Study Coordinator - Clinical Research

Pharma Medica Research Inc.•Toronto, ON

2d•CA$50,000 - CA$55,000•Onsite

About The Position

Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trails in healthy volunteers, special and patient populations. We are currently looking for a Study Coordinator to join our clinic location in Scarborough. The function of the Study Coordinator I is to plan the study activities under the supervision of the Study Coordinator II. Assist, and when necessary, supervise and/or perform all technical functions required to generate data in compliance with protocols, Pharma Medica Research Inc.’s (PMRI’s) SOPs, GCP requirements and other regulatory guidelines. Be aware at all times of the human safety factors. Ensure that procedures are performed in a timely manner. Answer technical questions from technicians. Monitor adverse events. Assist in the supervision and direction of technical staff on study in terms of performance of functions. This position reports to the Manager, Clinical Operations and/or designate.

Requirements

Minimum B.Sc. degree with 1 year experience in conducting clinical trials
Working knowledge of Phase I study Protocols and conduct.
GCP training.
Proficiency in computer usage and software applications.
Excellent communication skills including excellent English verbal and written skills.
Ability to communicate clearly and effectively with direct reports and other clinical staff.
Excellent interpersonal skills.
Ability to work both independently and as a team member.
Flexibility with changes in working schedules/shifts.
Exceptional organizational skills
Eligible to work within Canada.

Nice To Haves

M.Sc. degree with adequate knowledge of conducting clinical trials.

Responsibilities

Plan and supervise the timely execution of studies under the supervision of the Study Coordinator II.
Generate a study summary based on the protocol.
Ensure that regulatory documents like FDF, FDA 1572, QIU, ERB Letter of Approval, NOL, etc. are available prior to study check-in.
Coordinate the ordering of study-specific materials to conduct clinical studies.
Conduct pre-study protocol review meetings for the technical team.
Ensure that the study schedule is prepared in compliance with the study requirements.
Communicate with the Study Preparation Coordinator and the QC unit to ensure that appropriate CRFs are prepared prior to study check-in.
Liaise with the Screening department to ensure that queries pending at check-in are addressed prior to drug administration.
Ensure that the study drugs are received prior to study conduction.
Communicate with the Principal Investigator to ensure that an Investigator is present to perform the necessary physical examination and monitoring procedures.
Ensure that the ICF is provided to the subjects, answer any questions the subjects may have regarding the protocol and Informed Consent, and sign the Informed Consent forms.
Supervise and when required, assist and/or perform all technical functions: phlebotomy, ECG, vital signs and other clinical tasks to generate data in compliance with protocol, SOPs and GCP requirements.
Perform safety-related procedures as required (e.g. conducting vital signs, electrocardiograms, concomitant medication administration) and health monitoring.
Assist or administer certain types of investigational products as required for the conduct of a clinical study under the supervision/order of the investigator.
Ensure subject safety by timely documenting and following-up on Adverse Events.
Ensure all study documentation is accurate, current, and complete according to study protocol, SOPs, GCP, and other regulatory guidelines.
Coordinate with the Project Management department regarding study related issues and project deadlines.
Assist in resolving conflicts among subjects and address subjects’ concerns.
Generate client updates and forward to the Project Management department as required.
Coordinate with the accounting department regarding study subjects’ compensation.
Ensure the timely shipping of the clinical and analytical samples.
Assist in performing final review of study documentation, ensuring accuracy according to protocol, SOPs and GCP, and other regulatory guidelines.
Ensure timely completion of deviation forms as needed.
Ensure timely receipt and review of post-study laboratory reports.
Ensure timely completion of the study files according to project deadlines.
Address queries and audit findings from QC and QA.
Coordinate the transcription of raw data onto CRFs where necessary.
Update the subjects’ files for outstanding follow-ups, subjects’ behavior issues, non-compliance, etc.
Other duties as required.