Senior Clinical Research Coordinator

JOB SUMMARY:

The Dragoo Research Program, located at the Inverness Orthopedics and Spine Center - Steadman Hawkins Clinic, is seeking a Senior Clinical Research Coordinator (Sr. CRC) with Clinical Research experience. The Sr. CRC role requires proficient communication with several entities, physicians, and researchers, as well as leading clinical trials and regulatory requirements for human subject research.
The Sr. CRC will be responsible for maintaining a thorough understanding of assigned human subject research protocols and projects, particularly focusing on the biobanking initiative (CUREBANK), investigator-initiated studies, and industry-sponsored research. The Sr. CRC will report to the Program Manager and provide technical and administrative assistance to Dr. Jason Dragoo’s research team. Duties include engagement in technical research activities, laboratory functions, data entry and oversight using electronic systems, and ensuring compliance with reporting requirements for protocols and projects.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in any field
• A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis
• Two (2) years Clinical Research or related experience

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in science or health related field
• Three (3) to four (4) years of Clinical Research or related experience
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification.
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Four (4) years of Clinical Research, preferably clinical trials, or related experience.
• Knowledge and understanding of Good Laboratory Practices (GLP).
• Experience with RedCap, EPIC EHR, OnCore, and Microsoft products.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
• Ability to communicate effectively, both in writing and orally
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
• Outstanding customer service skills
• Demonstrated commitment and leadership ability to advance diversity and inclusion
• Knowledge of basic human anatomy, physiology medical terminology
• Ability to interpret and master complex research protocol information

• Assist with and oversee the day-to-day operations of clinical trials and studies
• Obtain study subject’s medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
• Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
• Updates study calendar of various clinical protocols and coordinates logistics needed for successful completion of the studies.
• Serve as a primary contact for regulatory bodies, study participants, Sponsors, and fellow researchers, handling tasks such as scheduling, confirming appointments, etc.
• Screens, recruits, and obtains informed consent from potential candidates for research studies.Coordinates study clinic visits, and performs protocol-specific research activities including, but not limited to, concomitant medicine checks, physical histories, AE/SAE/UAP checks.