Senior Clinical Research Nurse Coordinator - Pm&R

Position Summary

The Senior Clinical Research Nurse Coordinator (SCRNC) provides leadership and direct clinical research coordination of VCU CERSE (Center for Rehabilitation Science and Engineering) clinical trial research protocols (in collaboration with treating physicians, clinicians, and/or principal/co-investigators). The SCRNC helps ensure the safety and welfare of candidates for and participants in clinical trials, with an emphasis on randomized-controlled trials that evaluate the safety and efficacy of high-risk experimental interventions for vulnerable populations. The SCRNC coordinates all aspects of clinical trials, including human subject protection and regulatory compliance; nursing expertise; protocol development, implementation, documentation, and monitoring; data collection and quality assurance; team and institution-wide communication. The SCRNC serves as a VCU CERSE subject matter expert on clinical trial research protocol development, human subject protection, and federal and local regulatory compliance, with an emphasis on randomized clinical trials for high-risk experimental interventions in vulnerable populations. The SCRNC will also oversee the onboarding of industry-sponsored clinical trials.

Typical Duties

The Senior Clinical Research Nurse Coordinator’s general responsibilities include the following:

• Develops, establishes, and maintains productive relationships with VCU Central Virginia Veterans Healthcare System, Sheltering Arms Institute research team colleagues, and all customers and contacts at participating sites to achieve essential research outcomes.
• Serve as a senior research coordinator subject matter expert for an emerging central coordinator pool; work with leadership to lay the groundwork for expanding a coordinator pool, overall portfolio staffing, and management. Assume responsibility for oversight of additional CRC staff as support needs grow.
• Maintain advanced understanding of clinical research management duties from study initiation to close-out.
• Collaborates closely with Principal Investigator (PI), co-investigators, and clinical research team to ensure that key federal/state/local regulatory requirements are followed; that institutional operational research objectives are met; and that ethical obligations are kept.
• Evaluates, uses, and refines systems for data collection and collaborates with research team members to ensure data accuracy and integrity.
• Maintain all required credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as required.
• Be directly responsible for study coordination and regulatory management of an assigned portfolio of clinical research studies covering a variety of diseases and conditions.
• Collaborates with providers and research team members to facilitate the clinical research nursing, coordination and data management components of the clinical trial program.
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols.
• Follow VCU and SOM internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards.

Minimum Hiring Standards

• Ability to attend meetings within service area and at training locations.
• Strong communications skills, attention to detail and time management skills are key.
• Independent decision-making skills.
• Ability to work collaboratively and cooperatively in large and complex organizations with diverse and fast-paced work environments.
• CERSE supports a diverse faculty, staff, and student environment. The candidate will demonstrate experience that shows their commitment to fostering such an environment.
• Current Registered Nursing License in Virginia.
• Excellent interpersonal skills.
• 3 years minimum direct experience managing study coordination and regulatory affairs for clinical trials.
• Ability to provide own transportation to meet with patients within service area.
• Must be able to complete mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training.
• Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.
• Must possess the ability to set priorities, make timely decisions, and meet deadlines while working on multiple projects.
• Expertise with antineoplastic agent administration. Clinical experience in oncology.
• Current knowledge and advanced application of clinical trial research, human subject protection, and federal and local regulatory compliance, with an emphasis on randomized clinical trials for high-risk experimental interventions in vulnerable populations.

Preferred Hiring Standards

• Master’s Degree in Nursing from an accredited school of nursing, or an equivalent combination of training and experience.
• Active clinical research certification, e.g., SOCRA, ACRP, or ability to obtain certification
• BSN from an accredited school of nursing or an equivalent combination of training and experience.
• Knowledge and experience with rehabilitation populations, e.g. brain injury, spinal cord injury, stroke, limb loss, cancer, pain, etc.
• 5 or more years direct experience in clinical research management; prior experience at an academic medical center strongly preferred.
• 3 years of experience conducting industry-sponsored clinical trials.
• Experience managing multi-site trials, consortium studies, and/or large complex clinical research programs

Position will remain open until filled.

UNIVERSITY JOB: Senior Clinical Research Coordinator, Licensed 1-3
This is a restricted position with no set end date; continued employment is dependent upon the availability of funding.
Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education. All full-time university staff are eligible for our generous benefits package that includes choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off, 12 paid holidays, and more. Explore our benefits further here: https://hr.vcu.edu/current-employees/benefits/university-and-academic-professional-benefits/
Virginia Commonwealth University is an equal opportunity, affirmative action university providing access to education and employment without regard to race, color, religion, national origin, age, sex, political affiliation, veteran status, genetic information, sexual orientation, gender identity, gender expression, or disability.
The School of Medicine continuously strives for our workplace and learning environment to reflect the demographic and social milieu of the communities we serve. All qualified applicants are encouraged to apply.

Salary Range: Up to $90,000; Commensurate with Experience

Position Details:

Department: Physical Medicine and Rehabilitation
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE: 100
Exemption Status: Exempt

ORP Eligibility: No

Contact Information:

Contact Name: Nickie Thomas

Contact Email: [email protected]