Perform routine and moderately complex on-site and in-house site assessments independently for clinical trials research. Perform complex on-site and in-house site assessments with direction. Use critical thinking skills to monitor sites' compliance with study, sponsor, organizational, and government guidelines. Collect, document, update, and report study information according to procedures and timelines. Create new and customize existing templates and processes to meet project needs with some direction. Follow up, resolve, and report on issues identified during study monitoring and assessment activities with minimal to no direction.
- Participate in site selection and training site personnel regarding the trial; perform site routine monitoring of the trial and follow-up to ensure identified deficiencies are corrected; travel as required inside and outside of the U.S.A.to accomplish responsibilities.
- Coordinate the development of protocols, documentation and standard operating procedures for the administration and monitoring the clinical trials.
- Follow established guidelines in the collection of clinical data and/or administration of clinical trials; assist in the determination guidelines for new protocols.
- Coordinate the assessment of the suitability of potential investigative sites through telephone screening interviews, regulatory document review and disseminating clinical trial information; conduct site qualification visits to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of principal investigator to conduct and complete the planned clinical study.
- Conduct site initiation visits for the purpose of training site personnel on the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, case report form completion and retention requirements, drug accountability procedures, serious adverse events (SAEs), reporting procedures and overall management.
- Conduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and adherence to procedures through review of CRFs, source documents, medical records, and regulatory documents.
- Provide feedback to assist sites which includes summary of overall site functioning and detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved.
- Perform other related duties incidental to the work described herein.
Required Qualifications at this Level
Work requires graduation from. an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus two years of healthcare experience; or one of the following equivalents:
- Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of four years healthcare experience; or
- Completion of a master's degree in Public Health,., Health Administration or a related area with. one year directly related clinical trials research experience; or
- Completion of a bachelor's degree plus a Minimum of two years directly related experience in clinical trials research; or
- Completion of a bachelor's degree plus a minimum of three years closely related research experience.
**State of North Carolina license may be required.**
None :required beyond that described above.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE