The Clinical Research Manager plans, directs, and manages all Clinical Research staff and resources. The Manager oversees the clinical monitoring process, the administration of clinical trials, and acts as the liaison between the investigators, primary care providers, the institutional review boards (IRBs), and the sponsor or other study management firm.
- Find research studies
- Negotiate budget and contracts
- Watch balance sheet to assure Center is being paid for work performed
- Account research payments
- Invoice for negotiated items
- Negotiate for payments not received
- Maintain investigator payments
- Generate payments sheet quarterly so that accounting can make the research payment.
- Ensures the maintenance of accurate and complete documentation of regulatory documents, signed informed consent forms, relevant IRB approvals, source documentation, drug dispensing logs, subject logs, and other study-related communications.
- Oversees the organizational management of all aspects of the trial, including timeliness in completing case report forms (CRFs), data entry, adverse drug experiences (ADEs) reporting, communication with the IRB, caseload management, study files management, and trains clinical staff and physicians on the scope and requirements of research studies.
- Is responsible for budgets and contracts for research studies and the management of all aspects of study implementation (visits by the sponsor and their monitors, physician payments for Clinical Research Duties, profitability and annual financial goals for the department).
- Develops a department budget for staffing, supplies, capital expenses, and other expenses that apply and ensures that the department operates within allocated funds.
- Successfully solicits research studies from sponsors, CROs, and other sources.
- Develops policies and procedures (SOPs) for Clinical Research Studies, manages all Clinical Research personnel, and ensures adherence to SOPs, Good Clinical Practice and FDA regulations.
- Ensures that investigators and sub-investigators are properly trained and credentialed under Corvallis Clinic policies and procedures and provides quality assurance regarding activities and documentation performed by the investigators.