Study Coordinator - CRO

at  Pharma Medica Research Inc

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 an Study Coordinator to join our clinic location in Scarborough.
The Study Coordinator supervises the planning for clinical studies. Supervises and/or performs all technical functions necessary to generate data in compliance with protocols, SOPs and GCP. Ensure that procedures are performed in a timely manner. Answer technical questions from technicians. Monitor Adverse Events. 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.

QUALIFICATIONS:

• Minimum B.Sc. degree with 1 year Phase I clinic experience or
• 2 years related experience within a Phase I clinical center.
• Clinical Research Coordinator designation as per ACRP guidelines.
• Excellent understanding of Phase I study protocols and conduct.
• Understanding of the value and necessity of training and SOP’s relating to study conduct.
• GCP training.
• Excellent computer skills.
• 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.
• Exceptional organizational skills

• Ensure that the final protocol, signed regulatory documents, and NOLs are available prior to study conduction.
• Prepare the study-specific staff schedule.
• Ensure that the study CRFs are prepared, study supplies are available, and and the clinic is set up prior to study check-in.
• Coordinate with the Pharmacy department to ensure that the study drugs are available in the clinic prior to study check-in.
• Set up and conduct pre-study protocol review meetings of study activities for technical team.
• Coordinate ordering of study specific materials to conduct clinical studies.
• Supervise and/or perform all technical functions: phlebotomy, ECG, vital signs and other clinical tasks to generate data in compliance with protocol, SOP and GCP.
• Ensure subject safety by monitoring and documenting Adverse Events.
• Coordinate with the Accounting department regarding timely preparation of subjects’ compensation.
• Generate client update and forward to Client Services as required.
• Perform final review of study documentation, ensuring accuracy according to protocol, SOPs and GCP.
• Ensure all study documentation is accurate, current, and complete according to study protocol, SOPs, GCP, and regulatory guidelines.
• Coordinate transcription of raw data onto CRFs where necessary.
• Ensure the timely submission of study files to QA and Report Writers.
• Assist is resolving conflicts among subjects and address subjects concerns.
• Address queries and findings from QC unit and QA’s.
• Other duties as required.