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OUR CURRENT CAREER OPPORTUNITIES

Want to be inspired?

Seeking highly motivated, innovative thinking, medical and scientific professionals.

With an emphasis on personal growth and development, BioPharma Services strives to create an environment where our people matter.  To provide excellence by inspiring enhanced performance to advance medical research and creating a team to drive results.  We take pride in the work we do and welcome all individuals that want to join our dynamic culture and be a part of our brand.

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

Toronto, Ontario - Clinical Research Coordinator

Duties and Responsibilities:
  • Coordinates, executes and monitors all study activities to ensure conduct of clinical trials in accordance to study protocol, BPSI SOPs and/or Directives, ICH-GCPs and applicable regulatory guidelines
  • CRCA assists CRCs with Study related duties
  • Conducts protocol training for clinical research staff
  • Performs compliance check on subjects as applicable
  • Reports Adverse Events and Serious Adverse Events to appropriate department(s)
  • Supervises, administers and/or assists in a drug administration
  • Assists with dispensing, appropriate control, inventory, storage and record keeping of study drug(s) as required
  • Maintains study files for each clinical trial and performs detailed review of created and prepare by Study Preparation Associates subject and study source documentation and/or CRFs, as well as of completed Source Documents and CRFs
  • 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
  • Ensures the accuracy of the generated data in accordance with protocols, ICH, GCP and applicable regulatory agencies
  • Maintains adequate, accurate, complete and legible records
  • Collaborates 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.)
  • Participate in staff training sessions
  • 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.
  • Certification in Clinical Research is an asset.
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements.
  • 1-2 years work experience in a CRO (preferably in conducting Phase I /Bioequivalence clinical trials)
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Excellent in Microsoft Word and Excel.
Please send your application to resumes@biopharmaservices.com

Toronto, Ontario - Scientific Medical Writer

Duties and Responsibilities:
  • • Write Phase 1-IV and Bioequivalence Study Protocols and Informed Consent Forms.
  • • Perform Literature search, NDA review and scientific discussion relevant for designing a study protocol for BE and Phase 1-2a (Proof of concept)
  • • Review non-clinical data in preparation to transition to the First in Human clinical trial.
  • • Interact efficiently with PK Scientists and Biostatisticians to make sure that the study design is in line with the most updated regulatory and scientific requirements
  • • Interact with Institutional Review Boards with respect to Protocols, Informed Consent Forms and other documents as required.
  • • Assist in the development of Standard Operating Procedures (SOPs) and guidelines linked with the department activities.
  • • Assist with the preparation for Regulatory agencies and participate if needed in any discussion with the inspectors.
  • • Work closely with scientific, clinical personnel, and the Principal Investigator to ensure that clinical study protocol and other scientific documents are produced to the standard required by Good Clinical Practice (GCP), SOP and other applicable guidelines.
  • • Establish optimal timelines with external departments in order to meet study projects timelines.
  • • Perform other work within the Scientific Affairs department as needed.
  Qualifications:
  • • Minimum University degree, M.Sc. (i.e. Pharmacy, Pharmacology or other Life Sciences relevant degree).
  • • At least 2 years of Scientific Protocol design and Writing experience
  • • Experience in an CRO environment is an asset preferably in the conduct of Phase I and Bioequivalence studies
  • • Excellent scientific writing skills.
  • • Excellent interpersonal and communication skills.
  • • Attentive to details, good initiative and able to work with changing priorities under tight timelines.
  • • Previous participation in Scientific discussion with Agencies (e.g. Scientific Advice meeting in EU, Pre-IND packaging and meeting with FDA) is an asset.
  Please send your application to resumes@biopharmaservices.com

Toronto, Ontario - Biostatistician/SAS Programmer

Reports to:
  • Principal Biostatistician, Pharmacometrics
  Position Summary:
  • Biostatistician/SAS Programmer who will be responsible for the development of standard SAS Macros and programs in accordance with standard programming practices to design and develop Tables, Listings and Graphs as outlined in the Clinical Study Protocol and / or Data Analysis Plan. The qualified individual also is required to review the clinical study protocol and report, to assist in the development of the Data Analysis Plan, and development of SAS program of CDISC SDTM and ADaM according to dataset specifications
  Duties and Responsibilities:
  • Develop and validate SAS codes for the analysis of clinical study data, generate output tables, listings and graphs in according with the study protocol and the data analysis plan (DAP)
  • Create randomization scheme for clinical research studies
  • Perform the statistical data analysis for clinical research studies utilizing the validated in- house SAS codes according to study protocol and departmental SOP
  • Review data quality and statistical outputs (QC process)
  • Review the clinical study protocol and report
  • Assist in the development of the Data Analysis Plan for required clinical research studies
  • Involve in the creation of CDISC SDTM and ADaM datasets
  • Implement data specifications to transform study data into CDISC-compliant datasets (SDTM and ADaM) in XPT format using SAS for electronic submission under the supervision
  • Participate in the development of SAS codes to execute the back-end edit checks
  • Work closely with team to implement protocol methodology and statistical plan to assure timely, accurate, complete and consistent analyses for clinical data
  • Perform other miscellaneous activities as required
  Qualifications:
  • Sc in Statistics or Biostatistics, experience with SAS/Base, SAS/Macro, SAS/SQL and SAS/Graph
  • Experience with SAS/Stat is required
  • At least 1-2 years of Biostatistical consulting and/or SAS programming experience in the pharmaceutical industry or in the field of clinical research is required
  • Proficiency with Microsoft Office
  • Knowledge of clinical drug development process and knowledge of FDA and other regulatory requirements and ICH/GCP guidelines
  • Knowledge of Clinical Data Interchange Standards Consortium (CDISC) guidelines
  • Good interpersonal skills, good communication skills
  • Attentive to details, good initiative and able to work with changing priorities
Please send your application to resumes@biopharmaservices.com

Toronto, Ontario – Facility Cleaner

Shift Flexibility:
    • Mornings 6:00am-2:00pm / Afternoons 14:00-22:00 / Night Shift 22:00-6:00 / Weekends.
  Position Summary:
    • Cleaners are responsible for ensuring that the entire building is kept in a reasonably clean manner, at all times. They must follow their scheduled shifts and prioritize duties accordingly. Most importantly, they are to report all concerns immediately to a supervisor.
  Duties and Responsibilities:
    • Washrooms are first priority at the beginning, during and before finishing every shift. If there is a study in progress then this is the starting point of the shift.
    • Ensure all work is done with consideration to health and safety with regards to yourself and all others.
    • Consistently inspect the entire building for cleanliness
    • Dispose garbage from all rooms throughout the building
    • Ensure all the furniture is kept clean
    • Sweep and mop floor surface of the entire building including staircases
    • Ensure all carpets are vacuumed regularly
    • All glass is to be kept clean
    • All doorknobs, walls and countertops are to be wiped
    • Clean lunch room daily as often as necessary
    • Keep outside the building grounds and parking lot clean
    • Seasonal ice/snow remove salt
    • Making of beds throughout Clinic Dormitories
    • Report all problems and concerns to your supervisor, if a concern needs immediate attention and your supervisor is not available please inform an available supervisor.
  Qualifications:
    • Minimum High School or equivalent
    • Minimum 1-3 years prior work experience performing related or similar duties
    • Must be able to lift 50 lbs, bend, reach, climb stairs and stand for extended periods of time
    • Scheduling Flexibility:**
    •           Must be available to work day, afternoon and weekend shifts
    •           (variable shifts) based on business needs. **
    • Hard-working individual
    • Good communication skills
    • Professional mannerism
    • Ability to prioritize assigned tasks
    • Able to multi-task
  Please send your resume to resumes@biopharmaservices.com

Columbia, Missouri – Clinical Research Technician

Position Summary:

Responsible for collecting and processing blood samples from subjects as well as supporting the screening of subjects and ongoing compliance checks, collection of test specimens from subjects (with the exception of blood collection), assisting Nursing staff in obtaining Vital Signs, Height/Weight, Body Mass Index (BMI) and ECG data, and other activities in support of subject monitoring. Activities will also include processing of blood samples in a laboratory setting and assistance with preparing them for shipment. In addition, will serve meals and assist in keeping the Clinic clean. These activities require that the CRT read, understand, and train to the study protocol provided.

Duties and Responsibilities:

  • Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
  • Perform ECG and Vital Signs
  • Collect/process blood and urine samples as well as other specimens as required.
  • Perform drug/cotinine screen and alcohol test as well as urine pregnancy test.
  • Obtain body measurements, including height and body weight, and calculate Body Mass Index (BMI).
  • Proper collecting, handling, and processing of PK samples
  • Process and ship lab samples (if IATA certified)
  • Assist in drug administration by performing hand and mouth check
  • Serve and/or monitor meals
  • Maintain accurate, complete, legible and timely data entry
  • Perform screening reception duties as required, including but not limited to ID verification, recording of demographic information
  • Perform data review of the source and/or other related documents as required.
  • Perform any other duties as required by Management

Qualifications:

  • CRO experience a plus
  • CPR & First Aid certification a plus
  • Phlebotomy certification preferred
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements

Please send your resume to resumes@biopharmaservices.com

Columbia, Missouri – Clinical Assistant

Reports to:

Manager, Clinical Operations

Position Summary:

Responsible for assisting in screening of subjects and ongoing compliance checks, collection of test specimens from subjects (with the exception of blood collection), assisting Nursing staff in obtaining Vital Signs, Height/Weight, Body Mass Index (BMI) and ECG data, and other activities in support of subject monitoring. Activities will also include processing of blood samples in a laboratory setting and assistance with preparing them for shipment. Will also serve meals and assist in keeping the Clinic clean. These activities require that the CA read, understand, and train to the study protocol provided.

Duties and Responsibilities:

  • Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
  • Compliance check on subjects
  • Collect urine samples as well as other specimens as required.
  • Assist Nursing staff with obtaining Vital Signs, Height/Weight, Body Mass Index (BMI) and ECG
  • Perform drug/cotinine screen and alcohol test as well as urine pregnancy test.
  • Process and ship lab
  • Assist in drug administration by performing hand and mouth check
  • Serve and/or monitor meals
  • Maintain accurate, complete, legible and timely data entry
  • Perform screening reception duties as required, including but not limited to ID verification
  • Perform data review of the source and/or other related documents as required.
  • Perform any other duties as required by Group Leader, Manager, Designee

Qualifications:

  • CPR & First Aid certification preferred
  • International Air Transportation Association (IATA) Certification, preferred
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements

Please send your resume to resumes@biopharmaservices.com

Columbia, Missouri – QC Data Reviewer

Reports to: Supervisor, Quality Control   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 the 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.
Please send your resume to resumes@biopharmaservices.com