Clinical Research Coordinator, Department of Pediatrics, School of Medicine

PositionSummary:

VCU Department of Pediatrics are not just caringfor kids and families: were discovering new treatments improving outcomesand researching innovative new ideas. The Pediatric Research Office iscommitted to supporting VCU clinical researchers in advancing investigativemedicine.

This entry level position will support the Divisionof Pediatric Endocrinology and others as a member of the Pediatric Research Office.

The Clinical Research Coordinator (CRC) 1 supports upperlevel/senior CRCs and Principal Investigators (PI) in activities required foractivation execution and management of clinical patient-oriented researchstudies or protocols. Typical duties include but are not limited to determiningparticipant eligibility; serve as patient/participant recruiter and educator;and perform a variety of complex activities involved in the collectioncompilation and documentation of clinical research data.

This role includes responsibilities of the CRC towork independently and as a member of a team. Working under generalsupervision they resolve most standard issues independently and refer complexissues to the upper-level manager or the PI as appropriate.

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

Core Responsibilities:

Study Conduct (60%):
-Maintain understanding of clinical research duties from study initiation to close-out 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 (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.
-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 shareinformation.
-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.

Minimum Hiring Standards:
-Bachelors degree in health research and/or healthcare-related fields or equivalent combination of education experience and training.
-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.
-Active clinical licensure such as CMA CNA EMT LPN RN.

Preferred Qualifications:
-Experience in clinical research including regulatory human subjects protection study conduct and/or data management requirements.
-Experience working with families and/or pediatric population in an educational or clinical setting.
-1 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.

Additional Information:
University Title:RS Clinical ResearchCoordinator 1 34111N

ORP Eligibility: No

This position is open until filled.

Vaccination Health:Please note that if you are employed as a university employee working in any of the health systems 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 VCUs sponsored research the School of Medicine is internationally recognized for patient care and education. VCU School of Medicine comprises 18 clinical departments eight basic health science departments and 11 affiliated institutes and centers and provides preeminent education to physicians and scientists in order to improve the quality of healthcare for humanity. 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 off12 paid holidays and more. Explore our benefits further here: 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.

Jewel Jefferson

Required Experience:

IC