Opportunities
Project Leader
Department: Clinical Operations
Reports to: Project Manager
Overview: The project Leader is responsible for coordinating the team effort of executing the technical and clinical functions required by the study protocol and leading the study team to facilitate study completion to meet timelines.
Responsibilities:
- Executes technical and clinical functions as required by the study protocol and according to Good Clinical Practice (GCP ) and RadPharm’ s Standard Operating Procedures (SOPs).
- Reviews protocols, raw data forms and other study specific paperwork to assist the study team in the appropriate implementation of clinical operations and to ensure accurate data collection and recording.
- Guides, supports and leads the RadPharm project team in carrying out assigned clinical trials.
- Coordinates the initiation and implementation of assigned clinical trials.
- Coordinates and directs the appropriate and timely imaging QA and reads for assigned clinical trials.
- Assists the radiologist, project assistant and project coordinator in imaging QA and reads as required.
- Knowledgeable about medical and research terminology.
- Records raw data (source documents, CRFs, etc).
- Enters, maintains and tracks data in the computer databases.
- Frequent liaisons with sponsor, contract research organizations (CRO) and investigator sites staff.
- Identifies issues and contacts sites & sponsors for issue resolution.
- Ensures confidentiality of study protocols and subjects is maintained.
- Participates in sponsor site visits and audits as requested.
- Interacts with all customers appropriately and professionally.
- Communicates effectively, verbally and in writing, with all internal and external customers (physicians, investigators, study coordinators, CROs, sponsors, coworkers, etc.)
- Reports study needs and issues to the Manager, Clinical Operations.
- Collaborates with management to resolve technical/radiological/study concerns and problems.
- Identifies and participates in the performance improvement process.
- Participates in the development, review and evaluation of SOPs and study specific procedures.
- Responsible for managing team members work schedule.
- Responsible for training and developing team members.
- Maintains a safe work environment. Reports workplace hazards immediately.
Qualifications:
- A Bachelors degree
- Medical terminology and knowledge of anatomy and physiology an asset
- Experience in research, health care or related field an asset
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