Clinical Research Coordinator, School of Medicine/Department of Pediatrics - Virginia Commonwealth University

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.

This position will support the Division of Pediatric Gastroenterology and others, as a member of the Pediatric Research Office.

Clinical Research Coordinators support Principal Investigators (PI) in activities required for activation, execution, and management of clinical, patient-oriented research studies or protocols. Typical duties include but are not limited to: determining participant eligibility; establishing guidelines for clinical data collection; serve as patient/participant recruiters and educators; and perform a variety of complex activities involved in the collection, compilation, and documentation of clinical research data. They work under general supervision, resolving most standard issues independently and referring complex issues to the upper-level manager or the PI, as appropriate. CRCs may work independently or as a member of a team.

Position open to various levels, depending on candidate experience.

Core Responsibilities:

Study Conduct (60%):
--Maintain understanding of clinical research duties from study initiation to close-out and ensure protocol compliance.
--Evaluate patients for eligibility to participate in studies treating various levels of disease severity.  Review medical records pertaining to these patients and present data to the investigator(s).
--Recruit participants for multiple studies. Tasks include attending clinics/rounds to discuss studies with patients and care team members, screen patient charts, determine eligibility for multiple studies, develop recruitment plans and reports of expected vs observed enrollment rate.
--Obtain consent and assent and act as a patient/family resource for further questions and/or concerns.
--Coordinate patient study visits with studyinvestigators and other clinicians; study visits may include biospecimen, datacollection, and real-time instruction for medical team administering investigative medicine.

--Prepare IRB submissions, including initial submissions, continuing reviews, amendments, safety reports, and serious adverse event reporting. Ensure all IRB submissions are complete and submitted on time.

--Maintain effective and ongoing communication with sponsor, participants, Pediatric Research Office, care team, and investigators during the study.
--Ensure patient safety is a top priority in the conduct of clinical studies.
--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.
--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.
--Other duties as assigned.

Data Management & Documentation (25%):
--Enter subject data into case report forms, databases, and VCU/VCUHS systems in a timely and accurate manner, and in accordance with sponsor and institution requirements. Build databases and logs as needed.
--Maintain study files according to GCP guidelines and in audit ready condition. Retain all study records in accordance with sponsor requirements and/or university policies and procedures. Participate in auditing and monitoring activities as assigned.

General / Administrative (15%):
--Support the Pediatric Research Office and assigned divisions by attending/leading events and trainings, assist team members in various study tasks (as needed, or as based on individual skill/education), and share information.
--Provide cross-coverage across studies within the Pediatric Research Office in true collaboration, which may include supporting other team members and performing administrative tasks as assigned.
--Work closely with managers, administrators, and finance teams to ensure appropriate study and budgetary management.

Minimum Hiring Standards:
--Experience in clinical research including regulatory, human subject’s protection, study conduct, and/or data management requirements.

--Ability to read, interpret, and apply complex regulations, policies, and requirements for each study assigned.

--Must be able to set priorities, maketimely decisions, and meet deadline in a fast-paced environment while working on multiple projects, seekingguidance from Principal Investigators andsenior study team staff when necessary.

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

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

--Participate in professional education and advancement opportunities facilitating personal and program growth.

--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.

--Able to provide own transportation to service areas and meeting locations.

Preferred Qualifications:
--Experience working with families and/or pediatric population in an educational or clinical setting.

--3 or more years direct experience in clinical research; prior experience at an academic medical center strongly preferred.

--Familiarity with VCU and VCUHS organization, processes, and systems (Epic, OnCore, Veeva Vault, and/or REDCAP) strongly preferred.

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

--Active clinical licensure such as CMA, CNA, EMT, LPN, RN.

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

This position is open until filled.

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.

UNIVERSITY JOB CODE: Clinical Research Coordinator (1-3) (34111N, 34112N,34113N)
ORP Eligible: No

Salary Range: $58,000 – $75,000

Position Details:

Department: SOM/Pediatrics
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE: 100%
Exemption Status: Exempt

Contact Information:

Contact Name: Jewel Jefferson

Contact Email: jewel.jefferson@vcuhealth.org