Manager, Clinical Research
The Clinical Research Coordinator is responsible for coordination and management of Phase I and Bioequivalence studies in accordance with the Protocol, Standard Operating Procedures (SOP’s), Directives, Good Clinical Practice (GCP) guidelines, and applicable regulations. The CRC is responsible for providing guidance and overseeing all aspects of assigned studies within the department as well as providing leadership, support and training to all study personnel
- Act as a project leader for assigned studies, coordinating all clinical activities throughout each stage of the project (including but not limited to: recruitment, screening, study planning and implementation through to completion of study).
- Monitor and track progress and execution of each study to ensure compliance with client timelines, study Protocol, SOPs, GCP guidelines and applicable regulations.
- Prepare, review and maintain study specific documents (Source Documents and Case Report Forms). Ensure quality and accuracy of data collected during the study.
- Participate in development, revision, and implementation of SOPs and Directives for Phase I and Bioequivalence studies as required.
- Review protocol and informed consent for accuracy, feasibility and resources.
- Interact with study Monitors, Investigators and Regulatory Authorities as necessary.
- Ensure the clinic is adequately set up with respect to staffing, equipment, supplies and facilities for assigned studies as per Protocol, SOPs and regulations.
- Provide leadership and support to all study personnel and act as a resource person on matters related to all clinical trials.
- Execute and lead various process improvement projects and assignments, as defined by the Department and/or Manager, Clinical Research.
- Responsible for remaining current with regulatory requirements (TPD, FDA, etc.)
- Participate in the development and implementation of staff training sessions and study initiation meetings
- Manage issues with volunteers, staffing and other study associated query resolution
- Maintain and communicate up-to-date study information and strategies to operatives, supervisors and managers.
- Additional tasks may also be assigned based on training, experience and qualifications e. vital signs, blood collection, assignment of more complex studies (first in man/innovator) training etc.
- Perform any other duties as required, as training and experience allow.
- A minimum of a post-secondary degree or diploma in a sciences or healthcare related
- Knowledge of research principles, ICH/GCP guidelines and applicable regulations
- Recognized certification in clinical research (e.g. ACRP or SoCRA) preferred
- Demonstrated experience with MS office (Word, Excel, Outlook, PowerPoint)
- Excellent interpersonal, verbal and written communication skills Good leadership skills are required.
- Ability to work effectively and efficiently in a fast paced, multitasking environment
- Detail oriented with effective decision making and problem-solving skills
- Ability to work flexible hours both day and evening shifts including weekdaysand evenings
- 1-2 years previous clinical research experience in CRO/pharmaceutical industry required
- (If internal) Successful completion of the Intern Clinical Research Coordinator