Senior Clinical Research Coordinator, School Of Medicine/Department Of Pediatrics

Senior Clinical Research Coordinator, School of Medicine/Department of Pediatrics Benefits of working at VCU

All full-time university staff are eligible for VCU's robust benefits package that includes: comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefit, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more. Learn more about VCU's benefits here.

Job Code Recruitment Pool All Applicants Posting Number req5734 Unit School Of Medicine MBU Department SOM/Pediatrics Department Website Link Location VCU Address 1000 East Broad Street, Richmond, VA 23219 USA Duties & Responsibilities

Position Summary:

VCU Department of Pediatrics and Children's Hospital of Richmond at VCU are not just caring for kids and families: we're discovering new treatments, improving outcomes, and researching innovative new ideas. The Pediatric Research Office is committed to supporting VCU clinical researchers in advancing investigative medicine.

The Division of Pediatric Hematology-Oncology seeks an experienced research professional to join their team as a Developmental Therapeutic Research Coordinator. This role will assist physician-investigators in managing complex clinical trials, with a likely opportunity for continued advancement as program growth continues.

This position will report to the Program Manager and work directly with Pediatric Hematology-Oncology Physician Investigators, and other divisions as assigned. This is an experienced coordinator role, with an intention to provide project management and support to researchers with investigator initiated and/or multi-site research studies with advanced job responsibilities across a variety of clinical and research areas. As a team lead, this position will provide mentorship and training to other coordinators, with the ability to assume responsibility for oversight as support needs grow or as department needs dictate.

Core Responsibilities:

Support the ongoing advancement of the Pediatric Department and Pediatric Research Office. (25%)

• Work with leadership to identify, develop, and evaluate resources and ongoing requirements to ensure Pediatric Research Office is current on Institution and clinical research standards and can implement process improvement and updated workflows.

• Provide information, expert advice, and instruction to investigators, research nurses/coordinators, and research support staff for planning, development, implementation, conducting, monitoring, and termination of pediatric clinical research trials.

• Model the development of best practice guidance and work aids in areas such as: study activation, study coordination, participant enrollment and consent, and data management.

• Develop and nurture relationships with principal investigators, all other members of the study teams, departmental personnel, colleagues, and co-workers throughout VCU, SOM and VCUHS, and study sponsors. Participate in study development/solicitation/identification to build portfolio of Pediatric research.

Perform study implementation and coordination tasks for studies assigned. (75%)

• Maintain an established, portfolio driven knowledge base of federal and state laws and regulations, sponsor guidance, as well as university policies, compliance notices, and internal processes, with ability to consistently interpret and apply accurately.

• Independently manage complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) clinical trials and registries. Responsible for initiating investigator-initiated IND/IDE clinical trials in collaboration with faculty supervisor.

• Work directly with physicians to design, set-up, and execute studies. Coordinate with physician investigators and clinical care to recruit, monitor, and manage participants on research protocols. Ensure protocol compliance and data quality are maintained. Ensure patient safety is a top priority in the conduct of clinical studies. Be directly responsible for day-to-day clinical research management.

• Be actively involved in participant recruitment (evaluate strategies, review medical records of upcoming new and return patient clinic visits and discuss with investigators, reach out to potential referring physicians, approach potential subjects, and ask pre-screening eligibility questions, etc.). May participate in the clinic to explain a trial and conduct informed consent with the patient and family.

• Review, understand, and champion trials in portfolio. Proactively communicate with investigators for any gaps in understanding. Perform staff in-service/education for nursing and ancillary units (e.g., laboratory, radiology, Investigational Drug Service) involved in the study. Perform ongoing study management in collaboration with other medical and nursing personnel and ancillary departments.

• Serve as a liaison between industry sponsors, contract research organizations, faculty investigators, other academic medical centers, and the Institution for promoting the conduct of clinical research in the Institution and in managing expectations and workflow for specific protocols.

• Participate in the protocol feasibility process for new research studies. Review and evaluate protocols for the following: identify issues/challenges and potential problems related to subject recruitment and assessment logistics; gather information for solutions; and to determine whether the trial is appropriate to conduct in this institution.

• Work with SOM administrative activation team; independently participate in the coverage analysis and budget feasibility process for new studies and amendments. Assist with identifying the protocol procedures specific to the research and the time required for the procedure. Collaborate with financial personnel to ensure appropriate information is provided to manage the research budget.

• Complete VCUHS orientation and training modules as required for the department and clinical research projects to obtain access to VCUHS clinical systems and clinical data. Conduct applicable clinical activities only as approved for each position on the clinical permission table and required for each clinical research project. Follow all VCUHS policies & procedures, including vaccination requirements and requirements for annual training. Job duties may include: entering information into the medical record; provide documentation assistance with transcribing provider orders; performing study assessments, including point of care testing; providing documentation assistance with transcribing provider orders in EPIC; the handling, transportation, access to and/or contact with medications and related supplies; minimum qualifications include HIPAA training, EMR navigation/computerized order entry. Performance and continued competence will be periodically assessed.

• Participate in cross-training and cross-coverage for other members of the Pediatric Research Office, ensuring no lapse in administrative aspects of study management or study. Occasional ability to shift schedule to provide on-call/after-hours coverage for research projects as needed.

• Other duties as assigned.

Qualifications

Minimum Hiring Standards:

• 3 years minimum direct experience managing study coordination and regulatory affairs for complex investigator initiated and industry-sponsored clinical trials.

• Bachelor's degree or equivalent applicable combination of training, education, and experience.

• Strong communications skills, attention to detail, and time management skills are key.

• Must possess the ability to set priorities, make timely decisions, and meet deadlines while working on multiple projects.

• Ability to work collaboratively and cooperatively in a large and complex organization and in a diverse and fast-paced work environment.

• 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.

Preferred Qualifications:

• 5 or more years direct experience in clinical research; prior experience at an academic medical center strongly preferred.

• Experience working with families and/or pediatric, adolescent, and young adult population in an educational or clinical setting.

• Experience managing multi-site trials, consortium studies, and/or large complex clinical research studies.

• Active clinical research certification, e.g., SOCRA, ACRP, or ability to obtain certification.

• Active clinical licensure such as CMA, CAN, EMT, RN, LPN.

University Job: Senior Clinical Research Coordinator (1-3) (34114N, 34115N, 34116N)

ORP Eligible: No

This position is open until filled.

This is a restricted position with no set end date; continued employment is dependent upon project need, availability of funding, and performance.

Please note that if you are employed as a university employee working in any of the health system's facilities, you will need to follow VCU Health System policies, which will include but will not be limited to, vaccination requirements.

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.

FLSA University Employee Job FTE 1 Exemption Status Exempt Restricted Position Yes E-Class UF - University Employee FT Job Category University Employee ORP Eligible No Salary Range $65,000 - $95,000 Compensation Type Salaried Target Hire Date 6/27/2024 Contact Information for Candidates

Jewel Jefferson

jewel.jefferson@vcuhealth.org

Documents Needed to Apply