Seeking a full-time Clinical Research Manager to provide clerical expertise to ensure all patients receive high quality, efficient care.
- Promote Research Department to various CRO’s (Clinical Research Organizations) and pharmaceutical companies to obtain clinical trials that are commensurate with its professional, financial and clinical goals and with its capability to complete them.
- Supervise Research Department Staff and coordinate clinical research trials conducted by Practice’s principal investigators meeting the objectives of assigned research protocol.
- Follow established guidelines in the collection of clinical data and /or administration of clinical trials; assist in establishing guidelines for new protocols.
- Ensure that study data is collected, assessed and reported in an appropriate and timely manner. Ensure that adverse events which may occur during investigational studies are appropriately investigated and reported.
- Confer with clinical staff and physicians to explain protocol and to elicit compliance with regulations; assure adherence to FDA and protocol guidelines, identify potential problems and/or inconsistencies and take action as appropriate.
- Draft reports, documents and correspondence for regulatory agencies, participating clinical trial sites, and for internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial program.
- Create and monitor budget for Research Department.
- Serve as primary liaison between Practice and Sponsors of various Clinical Trials. Serve as the primary liaison internally with staff.
- Ensure that protocols, agreements and investigator activities protect patient welfare; patient confidentiality and practice interests during all clinical investigations.
- Ensure that personnel at investigational sites are appropriately trained in the protocol and procedures prior to the initiation of any study. Provide ongoing management and support throughout the investigation.
- Identify barriers to clinical trial participation and foster approaches toward reducing them.
- Ensure distribution of appropriate forms, supplies, equipment, laboratory samples and drugs required for execution of research protocols.
- Engage for the purpose of marketing each Monitor at site visits.
- Review research and pertinent journals, abstracts and scientific literature
- Staff education
- Participate in professional development activities to keep current with health care trends and practices.
- Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”.
What Qualifications you will need:
- Graduate of an accredited school of nursing.
- Bachelor’s degree preferred
- Minimum of four years clinical research experience.
- Management experience preferred.