Clinical Research Coordinator 3, Non-Licensed, Department of Surgery

The Department of Surgery is seeking applicants for a Clinical Research Coordinator 3, Non-Licensed. A Clinical Research Coordinator 3, Non-Licensed (CRC-3, NL), holds a pivotal role in the clinical research field, performing a broad spectrum of duties with minimal supervision. This position demands an advanced understanding of clinical research procedures, Good Clinical Practices (GCP), and the federal and state regulations that govern clinical research. Here's a detailed overview of the key responsibilities and expectations for a CRC-3, NL:

Responsibilities:

Study Coordination and Management:

• Oversee the entire lifecycle of clinical trials from initiation to close-out.
• Ensure adherence to study protocols, GCP, and regulatory requirements.
• Facilitate the submission of regulatory documents to Institutional Review Boards (IRBs) and other regulatory entities.
• Prepare and maintain all study-related documentation, including case report forms (CRFs), informed consent documents, and regulatory binders.

Participant Interaction:

• Screen, recruit, and enroll study participants.
• Obtain informed consent and ensure participant comprehension.
• Schedule and conduct participant visits, including the collection of biological samples, data, and follow-up information.

Data Management and Analysis:

• Accurately record and enter data into electronic data capture systems.
• Monitor data quality and resolve data discrepancies.
• Collaborate with data management and biostatistical teams for data analysis and reporting.

Team Leadership and Training:

• Supervise and mentor junior CRCs and support staff.
• Provide training on study protocols, regulatory requirements, and best practices.
• Foster a collaborative and efficient team environment.

Liaison Activities:

• Act as a key contact between the research team, study sponsors, regulatory bodies, and other stakeholders.
• Coordinate study meetings, including site initiation visits, monitoring visits, and audits.
• Communicate effectively with Principal Investigators (PIs) and ensure they are kept informed of study progress and any issues that arise.

Regulatory Compliance and Quality Assurance:

• Conduct routine quality checks to ensure compliance with regulatory standards.
• Assist in the preparation for and conduct of internal and external audits.
• Implement corrective action plans as necessary to address compliance issues.

Knowledge and Skills:

• Regulatory Acumen: In-depth knowledge of FDA regulations, ICH GCP guidelines, and state-specific regulatory requirements.
• Clinical Expertise: Proficiency in clinical trial methodologies, patient care considerations, and medical terminology.
• Technical Proficiency: Familiarity with electronic data capture systems, clinical trial management systems (CTMS), and other relevant software.
• Communication Skills: Excellent written and verbal communication skills for effective interaction with study participants, team members, and external partners.
• Leadership: Strong leadership abilities to guide, motivate, and manage a team of CRCs and support staff.

Autonomy and Decision-Making:

A CRC-3, NL, is expected to operate with a high degree of autonomy, making informed decisions regarding study conduct and participant management. They work closely with Principal Investigators and may assume a leadership role in managing the day-to-day operations of the clinical research team.

Career Development:

This role is suited for experienced clinical research professionals seeking to advance their careers by taking on more complex duties and greater responsibility within clinical research. It provides opportunities for professional growth and the potential to contribute significantly to the success of clinical trials and the advancement of medical knowledge.

For questions about the position, please contact Robin Kelly, RN, at rlk5a@uvahealth.org.

MINIMUM REQUIREMENTS

Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.

Experience: Minimum of 3 years of clinical research experience required. Master's degree may substitute for 1 year of clinical research experience.

Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

This position will remain open until filled. This is a full-time, benefited position. For more information on the benefits at UVA, visit hr.virginia.edu/benefits . This position is a restricted position and is dependent upon project need, availability of funding, and performance. This position is eligible for a hybrid schedule, but will primarily be in person in Charlottesville, VA.

The University will perform background checks on all new hires prior to employment. A completed pre-employment health and drug screen are required for this position.

This position is not able to sponsor applicants requiring visas.

To Apply:

Please apply through the UVA job board , and search for R0061257 . Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'. Complete an application online with the following documents:

• Cover letter
• Curriculum vitae (CV)

Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.

References will be completed via UVA's standardized process Skill Survey. A total of five references will be requested via SkillSurvey during the final phase of the interview process.

For questions about the application process, please contact Jessica Russo, Recruiter, at sxv9zv@virginia.edu .

For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/.

The University of Virginia, i ncluding the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician's Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex, pregnancy, sexual orientation, veteran or military status, and family medical or genetic information.