Clinical Research Coordinator - SOM/Pediatrics

Job Details

Advertising Summary: 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.

Unit: School Of Medicine MBU

Department: Pediatrics

Duties & Responsibilities:

Position Summary:

VCU Department of Pediatrics 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 Hematology and Oncology and others, as a member of the Pediatric Research Office.

Clinical Research Coordinators support upper level/senior CRCs and Principal Investigators (PI) in activities required for clinical, patient-oriented research studies. Typical duties include, but are not limited to, determining participant eligibility, consenting participants, data entry, and simple laboratory tasks.

CRCs work independently and as a member of a team. Under general supervision, they resolve most standard issues independently and refer complex issues to the upper-level manager or the PI, as appropriate.

This role will report in-person in the VCU Health downtown area of Richmond, VA, with the potential for remote/hybrid work following onboarding, 3-6 months training, and manager approval.

Core Responsibilities:

Study Conduct (50%):

• Maintain understanding of clinical research duties and ensure protocol compliance.
• Assist in subject recruitment. Tasks may include attend 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, etc.
• Assist with consent and assent and act as a patient/family resource for further questions and/or concerns.
• Assist with coordination of patient study visits with upper level/senior CRC(s), study investigators and other clinicians; study visits may include biospecimen, data collection, and real-time instruction for medical team administering investigative medicine.
• Assist in the preparation of 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 (35%):

• 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.
• Assist in maintaining 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.
• Other duties as assigned.

General / Administrative (15%):

• Support the Pediatric Research Office and assigned divisions by attending 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.

Qualifications:

Minimum Qualifications

• Bachelor’s degree in health research and/or healthcare-related fields or equivalent combination of education, experience, and training.
• 1 or more years direct experience in clinical research; prior experience at an academic medical center strongly preferred.
• Must be able to set priorities, make timely decisions, and meet deadline in a fast-paced environment while working on multiple projects, seeking guidance from Principal Investigators and senior study team staff when necessary.
• Strong communications skills, attention to detail, organization, and time management are key. Please highlight these skills in your resume and/or cover letter.
• Demonstrated experience working in and fostering an environment of respect, professionalism and civility with a population of faculty, staff, and students from various backgrounds and experiences, or a commitment to do so as a staff member at VCU.
• 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.
• Able to provide own transportation to service areas and meeting locations.

Preferred Qualifications

• Experience in clinical research including regulatory, human subject’s protection, study conduct, and/or data management requirements.
• Experience working with families and/or pediatric population in an educational or clinical setting.
• 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.

Salary Range: Commensurate with Experience (up to $62,000)

Benefits: All full-time university staff are eligible for VCU’s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, 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.

FLSA Exemption Status: Exempt

Hours per Week: 40

Restricted Position: Yes

ORP Eligible: No

Flexible Work Arrangement: Hybrid

University Job Title: Clinical Research Coordinator 1, 34111N

Contact Name: Jewel Jefferson

Contact Email: jewel.jefferson@vcuhealth.org