POSITION: Certified Clinical Research Coordinator
POSITION SUMMARY: This positions primary responsibility is to manage all aspects of conducting clinical trials. Position must have thorough knowledge of the research process and the conduct of studies under Good Clinical Practice/ICH Guidelines according to the FDA federal regulations. The CRC is the hub of study activity at the site, acting as liaison between the investigator and sponsor/CRO/IRB/lab/PCPs, etc. As manager of the research studies, position is responsible for a myriad of tasks beginning with marketing/business development; data entry and management, communication and study close out.
ESSENTIAL FUNCTIONS AND JOB RESPONSIBILITIES:
- Reviews and works with Administrators, Investigating Physician, and Compliance Director on all contract-related matters.
- Plans for and tracks required education hours to maintain own certification status.
- Reviews and evaluates protocols with physicians and/or research team for feasibility.
- Prepares study start-up activities, including, but not limited to: budgets, worksheets (source documents), informed consents, IRB submissions and presentations, advertising, pre-investigation visits, study start-up meetings.
- Develops & implements subject recruitment strategy.
- Retrieves & evaluates patient medical records for determining subject eligibility.
- Assists investigators with patient screening, enrollment, interim visits, and final visits.
- Conducts clinical procedures (H&P, phlebotomy, ECGs, vitals, PFT, visual exams, assist physicians with any number of procedures).
- Answers phone calls and questions, review protocol & informed consent.
- Conducts subject interviews and schedule subject appointments.
- Assesses subjects as to compliance and adverse events.
- Follows up with subjects (study close-out, adverse events, change in medications, early termination, etc.)
- Administers study drug as needed and maintain the study drug dispensing/accountability log(s) if the pharmacy is not associated with the study.
- Assures timely completion of all study activity (physician’s and coordinator’s) as per sponsor request.
- Complies with documentation requirements by sponsor companies such as IRB reports & submissions (initial and interim), case report form completion, enrollment reports, adverse event and dropout dates.
- Addresses sponsor queries in timely manner.
- Performs study closeout activities.
- Processes, packages, and ships laboratory specimens.
- Data collection, recordkeeping, filing, copying.
- Specimen collection, processing, storage, and shipment.
- Maintains quality assurance, reviews source data & CRF entries, regulatory documents, recording & reporting study status information (study metrics).
- Attends study start up meetings conducted at the site for assigned duties.
- Maintains adequate communication among coworkers and physicians for study related issues.
- Fosters collaborative working relationships with coworkers, clinic, physicians, and their staff, hospital units and clinical research associates.
- Abides by the Code of Federal Regulations referring to Good Clinical Practice and International Conference on Harmonisation guidelines per protocol.
- Conducts physician and staff in-services.
- Knowledge of clinic policy and procedure manual.
- Participates as necessary in site audits by FDA or sponsors.
- Assists with management and training of ancillary staff and new Clinic Research Coordinators.
- Stays up to date on new legal guidelines impacting clinical research.
- Exhibits computer systems knowledge and proficiency as necessary to perform job functions.
- Demonstrates the attitudes and behaviors of The South Bend Clinic Service Standards.
- Performs other duties as assigned when appropriate.
- Adheres to HIPAA guidelines set forth in Clinic policies and procedures.
Qualified candidates must be a graduate of an accredited RN or LPN school with current IN license or baccalaureate degree in a health related field. Clinical experience required. Must be certified in clinical research or willingness to obtain.
Knowledge, Skills, and Abilities:
Must have a complete understanding of the clinical research process. Must be organized, meticulous, detail-oriented by nature. Must possess excellent communication skills including the ability to effectively communicate with individuals in varying socio-economic backgrounds. Must have the ability to manage multiple projects at one time. Must be able to work in close proximity to coworkers and maintain professional attitude. Must maintain professional conduct in the presence of subjects, peers, sponsors, monitors, and physicians. Must have the flexibility to work both independently and as a team member on assigned projects. Must have a working knowledge of computers.
Travel is required. Must attend investigator meetings, industry meetings/classes for continuing education as needed.