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With an emphasis on personal growth and development, BioPharma Services strives to create an environment where our people matter. Everything we do – and we do it with passion – is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.

Our BioPharma family is key to our success. We create an environment where the brightest minds have space to innovate. Where there are always new opportunities to learn and grow. Where you can feel at home. Our award-winning dynamic teams, specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials, are at the forefront of medical research advances every day. Could this be the right place for you?

Review our currently available opportunities and explore the possibility of becoming a part of our community of Clinical Research Professionals.

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BioPharma Services is committed to creating an inclusive workforce that encourages, supports and celebrates the diverse voices of our employees from any background. We believe diversity and inclusion drives innovation and makes our company stronger. Our objective is to hire great people and build a culture where difference is valued.

  • IN TORONTO, ONTARIO
  • IN ST. LOUIS, MISSOURI
Toronto, Ontario - Senior Clinical Research Coordinator
Job title
Toronto, Ontario – Senior Clinical Research Coordinator
Position Summary
 
Duties and Responsibilities
  • Coordinates, monitors and supervises all study activities to ensure proper execution of assigned clinical research trials (BE, Phase I, etc.) and to ensure that study protocols, BPSI SOPs, ICH-GCPs and regulatory requirements are met
  • Act as a Leader by advising CRCs, Study Preparation Associates, Clinical Research Technicians, and Safety Staff on proper trial execution based on protocol, SOP, and regulatory requirements
  • Conducts CRC and CRCA training.
  • Meets and addresses issues with study monitors, sponsors and regulatory agencies as appropriate
  • Respond to queries by internal departments on trial conduct
  • Participates in review and development of study protocols, BPSI SOPs, and internal procedures
  • Analyzes and develops action plans to address QA findings, including development of CAPA reports
  • Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements
  • Performs CRC, CRCA and/or Study Preparation Associate duties if required
  • Maintains adequate, accurate, complete and legible records
  • Detailed review of subject and study documentation, CRFs and source documents
  • Conducts Protocol training for clinical research staff and Investigators.
  • Works with QC and QA during audits and audit follow-ups
  • Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
  • Performs other tasks as assigned and as training and experience allow
Qualifications
  • Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience.
  • 3-5 years work experience as a Clinical Research Coordinator or similar role in a CRO (preferably in conducting Phase I/IIa clinical trials)
  • Certification in Clinical Research is an asset.
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements.
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Ability to work in a fast paced environment with a high degree of organization.
  • Excellent in Microsoft Word and Excel.
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

 

Toronto, Ontario - Crew Chief, Clinical Operations
Job title
Toronto, Ontario – Crew Chief, Clinical Operations
Position Summary
The Crew Chief, Clinical Operations is responsible for providing leadership, support, and guidance to all Clinic team members, and to coordinate daily operational activities of a study within the department. The Crew Chief leads a team of Clinical Research Technicians (CRTs) and is responsible for all activities related to direct supervision of those staff. The Crew Chief, Clinical Operations will also, in the absence of, and in consultation with, the Supervisor, Safety Team, provide guidance, support and direction to the Safety Team staff as required. The Crew Chief will serve as the main point of contact for any daily operational issues which arise in the clinic. The Crew Chief, Clinical Operations will work on a rotating 12 hour shift schedule in order to provide 24 hour a day coverage to maintain clinic operations. Shift patterns may fluctuate to meet operational needs. The Crew Chief, Clinical Operations key role is providing leadership and ensuring that the daily operation is functioning efficiently and safely, while in accordance with BPSI SOPs and study protocol at all times. The Crew Chief is to act as a designate for the Supervisor, Clinical Operations, and BPSI, and will be the main point of contact for all clinic related issues 24 hours a day. The incumbent must maintain any BPSI related and required clinical designation they have achieved, and be available to work in the clinic due to operational need.
Duties and Responsibilities
•Provide leadership, coaching, mentorship, and oversight to all clinic staff and
oversight for all daily operational functions.
• Accountable for staff health & safety in the provision of their duties.
• Make every effort to prevent or resolve operational issues as, or before they
occur and escalate issues to the appropriate member(s) of the leadership team
as required.
• Ensure any and all documentation is completed with regard to any incidents
which occur.
• Report as required on the activities of the clinic to members of management,
sponsors or related agencies.
• Conduct annual performance reviews with front line staff.
• Be a main point of contact for all clinic related issues and inquiries and act as
the designate for the Supervisor, Clinical Operations and BPSI while on shift at
all times.
• Ensure the general clinical duties are performed to prepare for the clinical study
and proper monitoring of clinical activities.
• Oversees the execution of clinical trials; coordinating all clinic activities on study
to ensure all clinic needs are met (tasks, subject safety, work schedules,
breaks, clinic set-up, etc.)

• Provide leadership as required during any emergencies or incidences which
occur and ensure that the Emergency Response Plan and related SOPs are
adhered to and all internal stakeholders are informed appropriately.
• Keep the Supervisor, Clinical Operations apprised of all incidents and issues
which occur through established reporting processes.
• Follow and provide feedback for action plans that address issues with study
monitors, sponsors and regulatory agencies.
• Ensure that Clinic staff attend onboarding and training, and ensure performance
reviews and coaching with staff occurs.
• Ensure clinical trial activities are conducted in accordance with the Protocol,
SOP, ICH, GCP and applicable regulatory requirements.
• Ensures the accuracy of the generated data in accordance with protocols, SOP,
ICH, GCP and applicable regulatory agencies.
• Provide insight for the creation and revision of SOP’s and internal procedures.
• Provide input for the maintenance of the clinic calendar, and address short tern
scheduling issues as they arise.
• Review and implement the clinic staff schedule and task assignments
• Lead, train and coach the team to ensure proper planning, organization and
execution of clinical research studies.
• Actively implement action plans to address issues brought up by QA, QC, Study
Monitors, sponsors and regulatory agencies.

Qualifications
  • Knowledge of Good Clinical Practice
    • Able to work in a research setting and aware of the confidentiality that is
    required
    • At least 2 years’ experience in clinical research or related field
    • Computer literacy: MS Office, good communication skills, problem solving,
    organizational and leadership skills
    • Relevant previous leadership experience required
    • Readily available to work a 12 hour rotating schedule 24 hours a day is a
    requirement
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

 

Toronto, Ontario - Pharmacy Technician
Job title
Toronto, Ontario – Pharmacy Technician
Position Summary
Responsible for the overall operation of the Pharmacy including study drugs receipt, preparation and documentation according to study protocols, company policies and procedures. Ensure timely completion of study drug related tasks.
Duties and Responsibilities
• Review the study protocol for specific study requirements prior to the preparation
of pharmacy document and drug dispensing.
• Receive, prepare and retain study drugs according to study protocol, sponsor
and/or applicable Standard Operating Procedures.
• Coordinate the acquisition of study drugs for method development studies.
• Interact with Project Management team in regards to the study drug shipment,
discrepancies and drug retentions.
• Responsible in training staff members in assist of drug dispensing and
reconciliation.
• Establish and maintain policies and procedures regarding drug preparation and
distribution according to GCP and company SOPs.
• Ensure timely, accurate and organized completion of assigned tasks within the
Pharmacy.
• Maintain restriction to Pharmacy area.
• Write and/or revise SOPs as required in accordance to the GCP/ICH, FDA and
TPD regulations.
• Facilitate pharmacy tour/orientation where required.
• Maintaining all pharmacy equipment and records.
• Dispose/destroy expired drugs and retention study drugs.
• Participate clinical meetings and training sessions as required.
• Provide reports to upper management as required.
• Execute other duties as assigned.
 

• Graduate from an accredited Pharmacy Technician program from Ontario.
• Ontario College of Pharmacist Certificate or equivalent may be an asset.
• Excellent verbal and written English Communication skills.
• Excellent interpersonal skills.
• Ability to work both independently and as a team member.
• Flexible in changing shifts or hours as required by study schedule.

Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

 

Toronto, Ontario - Project Manager
Job title
Toronto, Ontario – Project Manager
Position Summary
To oversee all associated activities related to a Phase I/BE study program from inception (i.e. Study award) to completion (i.e. issuance of final report). Maintain awareness of overall study requirements in accordance with finalized protocol and ensure this is adhered to in all projects managed under your responsibility.
Duties and Responsibilities

• Maintain a tracking process for the studies managed; including initiation, tracking,
timelines reporting, budgeting and report writing
• Within scope of position, provide sound scientific advice to clients either directly or
via other BPSI staff; co-ordinate teleconferences with appropriate personnel,
address client questions, concerns or comments
• Negotiate client’s milestones and assist staff as required
• Use appropriate communication tools to update clients on the status of their
project(s); should there be any deviation, immediately handle them appropriately
and if required notify Director, Project Management and/or Operations
• Actively participate in the weekly tracking meeting making sure you are current
with the most current information from operations and provide any new client
information
• Create and develop quotations for review by DPM and receive appropriate
signatures as required
• Follow up with existing accounts on new business opportunities and manage
activities around outstanding quotations, Confidentiality Agreements, Contracts
etc.
• Whenever appropriate, maintain awareness and provide input on study designs
and protocols
• Assist in the preparation and maintenance of all departmental reports and all
tracking databases; ensure that they are updated accurately and issued in a
timeline fashion (includes quotation and contract templates, weekly tracking
reports, financial reports etc.)
• Ensure appropriate documents have been reviewed and circulated within BPSI
prior to providing to clients
• If required, assist in promotion of BPSI at industry meetings and trade shows
• Maintain a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA,
ICH, TGA, ANVISA) and understanding of basic pharmacokinetics and statistics
• Assist finance department in developing transfer of pertinent financial information
• Coordinate client visits and follow up on requested documents from clients
including, but not limited to, regulatory documents, study documents, validation
report and brochures
• Perform other tasks and projects as assigned

Qualifications

• Bachelor of Science (B.Sc.) degree or equivalent
• Relevant background in the healthcare, pharmaceutical industry
• Minimum of 2 years experience in a project management role in either Phase I/BE
or Phase I – IV setting
• Familiarity with the management of all phase I/BE
• Demonstrated experience dealing with a wide variety of project stakeholders at all
levels in and across various organizational departments
• Excellent interpersonal, communication and presentation skills
• Strong organization, prioritization and problem solving skills
• Ability to manage and handle several projects simultaneously
• Highly proficient in MS Office Suite (Word, Excel, PowerPoint, MS Project)

Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

 

Toronto, Ontario - Senior Biostatistician
Job title
Toronto, Ontario – Senior Clinical Research Coordinator
Position Summary
The Senior Biostatistician is responsible for application of statistical methods, for providing statistical inputs, for producing Tables, Listings and Figures as assigned projects, and for reviewing the statistical outputs. The Senior Biostatistician is responsible for the development of Statistical Sections of Protocol including statistical methodology, statistical programming procedures, and data handling rules, and for the development of statistical analysis plan (SAP) along with mock shells in conjunction with cross-functional teams. The Senior Biostatistician needs to interact with internal teams and external sponsors, auditors and clients and to provide technical solutions and advice to staff and clients on statistical processes.
Duties and Responsibilities
• Provide statistical inputs on study projects, especially in the field of statistical
methodologies in study design, sample size estimation, statistical modeling, data
handling, analysis and reporting
• Work with PK/PD scientists, Statistical Programming, and Data Management
(DM) team to prepare SAP along with mock shells
• Work with programming team to develop and validate SAS codes for the analysis
of clinical study data, to generate statistical outputs: tables, listings and figures in
according with the study protocol and the statistical analysis plan (SAP)
• Review statistical outputs and clinical study report (CSR), and address the
comments
• Review CRFs, DMP or DVP as required
• Generate randomization scheme for clinical studies
• Provide technical advice to junior Biostatisticians as well as Statistical
Programmers assigned to the projects.
• Review clinical study report
• Work with Data Management team to provide inputs for the specifications of
CRFs
• Work with Statistical Programming team for the specifications of SDTM, ADaM
domains, derived datasets, and TLFs
• Provide inputs on the study data review guide and analysis data review guide
• Provide statistical consultations to the clients
• Archive study files
Qualifications

•M.Sc or Ph.D in Statistics or Biostatistics, experience with SAS/Base, SAS/Macro, SAS/SQL and SAS/Graph
• Strong experience with statistical methods and modeling
• 3 years of Biostatistician experience in the pharmaceutical industry or in the field
of clinical research is required
• Proficiency with Microsoft Office

• Knowledge of GCP, guidelines and their application to global drug development
• Good interpersonal skills, good communication skills
• Attentive to details, good initiative and able to work with changing priorities

Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

 

Toronto, Ontario - Training Coordinator
Job title
Toronto, Ontario – Training Coordinator
Position Summary
 
Duties and Responsibilities
  • Orientation of New Hires and participate in onboarding of management staff
  • Create, review and revise Curriculum Vitae (CV) for new and existing employees
  • Create Job Profile in Dot Compliance
  • Create Training Plan for newly created Job/Standard Operating Procedure (SOP)
  • Create Training Plan (TP) in Dot Compliance and assign Standard Operating Procedure (SOP) requirements to TP
  • Assign employee to Job Profile in Dot Compliance
  • Management of SOPs:
  • Support Document Management Users (writers and approvers in Dot Compliance)
  • Create Classrooms in Dot Compliance
  • Generate Reports for audits (internal/external) and sponsor, management requests
  • Coordinate internal/external Trainings
  • Monitor Expiration of CVs and other training certificates
  • Create Audits in DOT Compliance
  • Facilitate preparation of training certificates for employees upon successful completion of course
  • Organize the process to maintain and archive employee training records
  • Create and update Presentations for Annual trainings
  • Coordinate Co-op student trainings
  • SOP Index: Notify SOP authors of upcoming expirations
  • Performs other tasks and projects as assigned
Qualifications
  • Bachelor’s degree in related field or minimum 2-4 years prior work experience performing related or similar duties
  • Three (3) or more years of experience developing and deploying Regulatory, Quality and Compliance related training and development programs in a highly regulated environment highly desired
  • Good written and verbal communications skills
  • Excellent interpersonal skills with a strong customer service focus
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

 

Toronto, Ontario - Principal Investigator
Job title
Toronto, Ontario – Principal Investigator 
Position Summary

The principal biostatistician will be responsible for all matters relating to planning, preparation, review and interpretation of data for clinical studies for regulatory submissions, and providing both leadership skills as well as technical expertise to the project teams. The incumbent will participate in developing clinical trial protocols, write/review SOPs relative to Biostatistics, write Statistical Analysis Plans, perform statistical analyses, and generate Statistical and Clinical Study Reports.

Duties and Responsibilities
  • Serves as the primary statistical role which is accountable for coaching, mentoring and developing, other statisticians and programmers
  • Supervise the activities of the biostatistics team to meet corporate goals and objectives
  • Develop SAS codes to create accurate, complete and efficient statistical analysis datasets and to generate statistical analysis output tables, listings and graphs
  • Implement SAS programming validation
  • Collaborate with management across functional areas to set priorities and timelines
  • Provide critical review of clinical trial protocols and clinical study reports
  • Provide advice on study design including identification of clinical endpoints and sample size estimation
  • Review Ensure the quality and integrity of the clinical study report
  • Develop statistical analysis plan for clinical studies
  • Contribute expert statistical input on regulatory questions
  • Represent department and the company to provide scientific consulting of external and internal clients and to take a leadership role in scientific research activities in the field of biostatistics
  • Write/review SOPs relative to Biostatistics
Qualifications
  • Sc. in biostatistics and 6+ years clinical research experience in pharmaceutical industry or CRO
  • 10+ years of biostatistics experience in related fields
  • In-depth knowledge of pharmaceutical clinical development and ability to apply technical principles, theories and concepts to clinical drug development
  • Strong leadership and guidance on statistical matters to interdepartmental clinical and regulatory teams
  • Understand regulatory drug submissions and approval process at the regional level
  • Understanding of statistical concepts and techniques and of clinical trial principles
  • Thorough knowledge of SAS procedures and clinical data processing with emphasis on regulatory agency requirements for data reporting
  • Extensive knowledge of FDA, TPD, and EMEA /ICH regulations/guidelines
  • Excellent written and verbal communication skills and interpersonal skills
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

 

St. Louis, Missouri - QC Data Reviewer
Job title
St. Louis, Missouri – QC Data Reviewer
Position Summary
Responsible for reviewing of all study related documentation to ensure the quality, reliability, accuracy, completeness and consistency according to Protocol, SOPs and Regulatory requirements. Other responsibilities as assigned.
Duties and Responsibilities
• Review study files after completion and ensure that they are accurate and legible according to protocol, SOPs and regulations
• Ensure all prepared study source documents and/or forms are in accordance to protocols, SOPs and regulations
• Review all other study related documentation: medical screening files, pharmacy labels and files, final report tabulations and PK STAT input and output as assigned
• Observe, on a random basis, clinical procedures during the conduct of studies, sample bundling and shipping process
• Provide reports of the reviewed data to relevant personnel/department
• Perform other duties as assigned by supervisor
Qualifications
• Post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
• 1-2 years of relevant clinical research experience, knowledge of ICH-GCPs and professional experience working in CRO
• Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.
• Excellent communication skills
• Excellent computer skills
• Certification in Clinical Research is an asset.
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to:  resumesstl@biopharmaservices.com

 

St. Louis, Missouri - Nurse Practitioner – Sub Investigator
Job title
St. Louis, Missouri – Nurse Practitioner – Sub Investigator
Position Summary
Sub-Investigator will be responsible for promoting Good Clinical Practice (GCP) in the conduct of clinical investigations by ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of the data generated and directing the conduct of the clinical investigations according to government regulations and guidance documents. Nurse practitioner to support Principal Investigator for clinical research studies. Apply medical techniques and principles under the direction of a physician for the successful execution of clinical research studies.
Duties and Responsibilities
• Ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.
• Read laboratory values and report abnormal values to investigator and patient.
• Regulatory document review.
• Verification and review and reporting of adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
• Provides Investigator Qualifications And Agreements; updated CV’s, current licenses, clinical investigations, signing regulatory documents
• Ensuring Protocol Compliance
• Ensures Initial And Ongoing Review By An IRB; provided information, documents, securing approval for studies
• Determines Adequate Resources Are Available To Conduct The Study; timing to conduct studies, adequate staff and supervision
• Manage The Medical Care of Subjects; responsible for trial related decisions, physical exams, evaluating adverse events etc.
• Protects The Rights And Welfare Of Subjects; GCP, reposting adverse events to sponsor and IRB, providing new info about the study
• Ensures Validity Of The Data Reported To The Sponsor;
• Ensures The Documentation Of Study-Related Procedures, Process And Events
• Ensures The Proper Use And Storage Of Investigational Products
• Direct Site Operations
Qualifications
• Master’s Degree in Nursing and graduation from a Nurse Practitioner Program.
• Updated active license with no restrictions
• Experience applying the following regulations and guidelines: GCP, HIPPA, The Protection of Human Research Subjects, OSHA
• Updated CPR or BCLS (ACLS is preferred)
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to:  resumesstl@biopharmaservices.com
St. Louis, Missouri - Office Administrative Coordinator
Job title
St. Louis, Missouri – Office Administrative Coordinator
Position Summary

First point of contact for visitors and callers to BPSI and to undertake a range of administrative duties.  As the “face” of our company, you will ensure visitors receive a heartwarming welcome by providing professional and friendly service.

Office Administrative Coordinator is able to identify and address the needs of senior managers and perform administrative tasks to ensure our company’s workflow runs smoothly.

Provide high-quality administrative and clerical assistance to senior management.  The Office Administrative Coordinator main duties are outlined below As an Office Administrative Coordinator, you should combine a pleasant personality with a dynamic professional attitude. Our ideal candidate can deal efficiently with complaints and has a solid customer service approach.

This role has a strong focus on schedule coordinating for our clinic. The ideal candidate will be highly detail oriented and working with management to efficiently and effectively generate, communicate, and manage schedules as per business needs.

Duties and Responsibilities

Reception:

  • Greet visitors, manage phone calls on company switchboard and emails in a professional manner
  • Check company voicemail, and transfer to appropriate person in a timely manner
  • Tracking and monitoring access cards and maintaining sign in logs
  • Sorting/distribution of incoming and outgoing correspondence

Administrative:

  • Ordering office supplies and managing inventory
  • Respond promptly to managers’ queries
  • Performs any other reasonable assignments given by the Department Management or his/she designates

Shipments – Outgoing/Incoming:

  • Schedules transportation requirements including shipment notification, tracking and proof of delivery (FedEx, Purolator, and occasionally world courier)
  • Compares identifying information and counts items of outgoing shipments to verify information against bills of lading, invoices, orders, or other records
  • Verifying and accepting deliveries and coordinating distribution

Scheduling

  • Coordinate and/or prepare the technical team activities, scheduling, task assignment, vacation request and replacements
  • Review scheduling and availability of Clinical Operations Staff
  • Create study tasks list reflecting procedures required by study protocols and internal SOP’s
  • Assist in the organization of training programs including SOP, GCP training, regulatory requirements, and other pertinent in-house training modules
  • Liaison with Managers, and Group leaders to keep track of attendance and/or changes in schedule
Qualifications
  • 2 years Customer Service experience
  • 1 year of supply ordering and inventory control experiences
  • 1 year of Schedule Coordination
  • College Diploma or Degree from a recognized University related to Business Administration
  • Fluent in written and spoken English with strong communication skills (via phone, email, and in-person) handling customer requests or challenges
  • Available to occasionally work on weekends
  • Proficient in office management systems, MS Office, online calendars, knowledge of office procedures and experience using office tools including printers/copiers and fax machines
  • Professional attire / appearance and manners
  • Organizational, planning, and multitasking skills with strong attention to detail
  • Able to work under pressure, action oriented and self-motivated with a demonstrated commitment to work as part of a team and independently
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumesstl@biopharmaservices.com
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    What are early phase clinical trials?

    Clinical Trials are divided into 4 phases.  Phase 1 and 2 trials constitute early phase trials, Phase 3 and 4 research studies are late-phase trials.

    The primary objective of Phase 1 studies is to determine the correct drug dosage by evaluating drug safety and determining if there are any side effects.  Phase 1 trials are conducted in healthy volunteers.

    Phase 2 studies also study the safety of a drug but focus on evaluating its effectiveness. These studies can be conducted in healthy volunteers or in individuals who have a certain disease or condition.

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    What is a clinical trial?

    A Clinical trial is a process which is performed to determine whether an investigational drug, device or therapy is safe and effective.   In early phase research (i.e. Phases 1 and 2), the safety and effectiveness of the drug will be evaluated in healthy volunteers.

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    What is an investigational drug?

    An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:

    • If the drug is safe and effective.
    • How the drug might be used in that disease.
    • How much of the drug is needed.
    • Information about the potential benefits and risks of taking the drug.
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    Why do you need to take blood draws and how many blood draws will be required?

    In order to evaluate the drug profile, we need to understand its pharmacokinetics. This is essentially how the body reacts to a drug after its administration through the mechanisms of absorption, distribution, as well as the metabolic changes. Therefore, blood draws are collected at various time points to better understand this mechanism. Each study requires a specific number of blood draws and total blood volume. These values will be provided to you and clearly stipulated in the informed consent form (ICF). The amount of blood that will be taken is outlined in the ICF.

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    Should I expect to experience any side-effects while doing studies?

    As every study is testing an investigational product, there may be side effects. You will be provided with a list of side effects that have been reported in previous trials (if any), so you can make an informed decision whether or not to participate in the trial. During the trial you will be required to immediately inform clinic study staff of any adverse effects that you are experiencing. These side effects usually resolve upon discontinuation of the study drug.

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    Will I be compensated for doing a clinical study?

    Volunteers are compensated and the amount varies depending on the length of the clinical trial, length of stay and number of follow-up visits. The compensation is not specifically related to the risks or type of drug involved in the trials or studies. Every study is different and therefore, the compensation will vary. Study volunteers may receive between $1000 to $4000 for a trial (based on the factors listed above).

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    Are food and accommodation provided over the course of the trial?

    Food – Clinical trials are conducted in a controlled setting which means that all food is provided and  trial volunteers receive standardised meals.  Individual meal plans or meal preferences cannot be provided.  If you have any food allergies or hypersensitivity to food product(s) that are clinically significant or life-threatening you may not be able to participate in a trial.    Please contact us to discuss any food issues.

    Accommodation – During your in-clinic stay you will share sleeping areas with other volunteers who are of the same gender.  Similar to a hospital setting, supervision will be provided to ensure that your health and safety are being monitored.

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    What is the length of a study and do I have to complete all the visits?

    Details of the duration of a study can be found on the Volunteer Hub.

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    Can I bring my own device?

    Yes, we encourage you to bring items that will help to pass the time while you are in the clinic. You can use the time to study or work or catch up on the movies you’ve been meaning to watch.

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    What do I need to pack?

    Wondering what to pack before your site visit? Visit our Packing List page to learn more.

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    When do I receive compensation for taking part in a study?

    You will receive compensation as outlined during the Informed Consent process. Typically, you will receive compensation once all study visits have been completed. If, for any reason, you do not complete all study visits, your compensation will be on a pro-rated basis (i.e. for the time that you have participated in the trial)

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    Where will I sleep during the clinical study?

    We provide a clean, safe socially distance sleeping environment, in a dormitory of hotel room style. Watch video

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    What COVID-19 precautions are you taking?

    The safety of our volunteers is a top priority. Learn more about the measures we are taking to create a safe environment for you.

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    Can I bring my own food?

    All aspects of clinical trials are closely monitored including the food and drink consumed by participants. While you are in the clinic, you will be provided with all meals as per the study guidelines. You will need to eat all the food provided to ensure the guidelines are met. Watch video

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    Privacy

    We respect and value the privacy of our volunteers. View our Privacy and Cookie Policy here.