Scope of the Job
Responsible for all aspects of research coordination for research studies ; Responsible for research specific quality nursing care for patients participating in clinical trials
1. Plan, implement and monitor participant recruitment and retention procedures
2. Interpret and implement protocol procedures and policy
3. Screen and interview study participants
4. Maintain case report forms, charts and documentation
5. Review lab and procedure results
6. Dispense medication and maintain records
7. Perform procedures as needed
8. Assists Division staff as needed
9. Assures that adverse events are reported in timely fashion
10. Maintain Regulatory documents as mandated by FDA regulations
Cross train with department research coordinators to act as back up to other study protocols, participates in on-call responsibilities for acute trials, and other duties as assigned by department director.
Coordinates recruitment and retention by in services. This may include physician referral letters and advertisements. Demonstrates knowledge of study protocol/policy by following study guidelines with 98 % accuracy. Continually establishes participant eligibility documents appropriately and reports to Research Manager. Appropriately documents with 98% accuracy and completion. Meets specified timelines. Refers abnormal lab or procedure results to MD or ARNP with appropriate follow-up. Appropriately dispenses and records study medications per guidelines. Evaluates participant overall health and study eligibility by review of subjective/objective data. Assists with filing, stocking of supplies scheduling, answering phones, and Division staff as requested by supervisor. Travels to appropriate study meetings or community in services. Accepts responsibility for additional assignments.
Coordinates special projects as needed
Fields research oriented calls/emails from physicians and other healthcare personnel
Must be able to perform under stress when confronted with emergency, critical, or unusual situations. Must be capable of dealing with periodic cyclical workload pressures and levels of responsibility. Required to make independent judgments without supervision. Must be able to make generalizations, evaluations, or decisions based on sound clinical, sensory or judgmental criteria. Must have the adaptability to perform a variety of duties, often changing from one task to another of a different nature without loss of efficiency or composure. Requires the ability to work with people beyond giving and receiving instructions.
Ability to perform phlebotomy
Knowledge of medical terminology
Understanding of clinical research process
Familiarity with the Code of Federal Regulations as they pertain to human subject clinical research
Strong interpersonal skills
Excellent communication and organizational skills
Strong computer skills including database management and spreadsheets
Strong calculation skills
RN with 2-5 years of nursing experience or Certified Clinical Research Coordinator 4 year degree in health science related field with clinical research experience
Educations & Certifications
Licensed Registered Nurse or Certified Clinical Research Coordinator required.
4 year degree in Health Science related field with Clinical Research experience