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 VCU’s generous benefits package that includes: competitive health benefits, paid annual and holiday leave, retirement planning and savings options, tax-deferred annuity and cash match programs, Virginia Retirement System (VRS), professional development & certifications, tuition waiver, parental leave, caregiving leave and community service leave. Learn more about VCU’s benefits here: https://hr.vcu.edu/careers-at-vcu/why-work-at-vcu/

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.
Position Summary:

The VCUSchool of Medicine Clinical Research Office (SOMCRO) is seeking candidates withan interest in clinical research to join the School of Medicine Clinical TrialCollaborative (SOMCTC). Thisis an hourly (< 29 hours/week) non-benefited, entry-level position that willprovide an opportunity to learn about clinical research coordination and operationsin a fast-paced, diverse environment while helping to support the success ofthe VCU School of Medicine’s research enterprise.

SOM is committed to supporting VCUclinical researchers in advancing medical science in our region. The entrylevel Clinical Research Coordinator is a key part of a team focused on implementingcoordination services for SOM investigators with the goal of providing 24/7enrollment support for Acute Care Clinical Trials. The selected candidate(s)will be responsible for conducting Clinical Research in the SOMCRO under thedirection of the Senior CTC Program Manager and Senior Clinical ResearchCoordination Staff. This position will require day/evening/nights on a rotatingschedule. Team members are designated to work during “off hours” to obtain thegoal of providing 24/7 study enrollment coverage among a collaborative ofresearch professionals. The work schedule may include weekends (Saturday and/orSunday) or holidays, as needed. The position will also present opportunitiesfor career growth for those presenting a willingness and ability to learn, bepro-active, and work collaboratively.

*EntryLevel Clinical Research Coordination Opportunity*
CoreResponsibilities:

StudyConduct (50%)

• Assist in subject recruitment: pre-screening and screening.
• Enrollment of eligible study participants
• Conduct the informed consent process.
• Monitoring patients within VCU Health during participation and throughout the study follow up period.
• Access data capture/retrieval systems to identify potential study participants.
• Coordination and filing of study documents.
• As assigned, support the PI and other senior study staff in following study participants through all study activities to ensure that the study is conducted in compliance with all requirements.
• Assist with required study close-out activities.

Data Management &Documentation (25%)

• Entry of study data for new and ongoing clinical research studies.
• Maintain study files according to GCP guidelines and in audit ready condition.
• Enter subject data into sponsor case report forms, databases, and VCU’s OnCore system in a timely manner and in accordance with sponsor and university/school –level requirements.
• Assist with the review and response to all sponsor query replies as assigned and within required time frames.

Regulatory& Compliance Requirements (15%)

• Ensure proper research protocol compliance.
• Conduct clinicalresearch activities as authorized by Delegation of Authority and Training Logs.
• Assist in the preparation and collection of all necessary study documentation.
• Maintain appropriate study documentation/records.
• Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as required.
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols.
• Conduct all assigned activities in compliance with national, local, & institutional guidelines, according to all HIPAA, GCP, and other applicable requirements.
• Preparation of IRB submissions including initial submissions, continuing reviews, amendments, safety reports, and serious adverse event reporting.
• Participate in SOMCRO and SOMCTC internal meetings.
• Ensure accuracy of subject data and compliance with research protocol and regulatory requirements.
• Participate in auditing and monitoring activities as assigned.

General /Administrative (10%)

• Cross-coverageacross studies and working with the SOMCRO team in true collaboration.
• Completing assigned clinical researchactivities in a compliant and efficient manner.
• Coordination of clinical research processes and documentation which may include filing and office organization, research participant scheduling, and ordering of study materials and supplies.
• Follow all university and School of Medicine procedures for management of clinical research.

Minimum Hiring Standards:

• Must be able to prioritize work requirements and multi-task in fast-paced environment, seeking guidance from Principal Investigators and senior study team staff when necessary.
• Ability to be flexible with working hours and shift requirements
• Exhibits professionalism and ability to work both independently and collaboratively as part of a team.
• Establish and maintain productive relationships with VCU colleagues and all customers and contacts necessary to effectively support research studies.
• Must be dependable and attentive to detail.
• Must be able to work in a diverse environment and encourage inclusion.
• Must be able to prioritize work requirements and multi-task in fast-paced environment, seeking guidance from Principal Investigators and senior study team staff when necessary.
• Ability to read, interpret, and apply complex regulations, policies, and requirements studies.
• Excellent organization, time management and critical thinking skills.
• Accuracy, precision, and efficiency in work habits are required.
• Must be able to use time effectively, multi-task, and work independently.
• Must have a demonstrated commitment to fostering diversity and inclusion in past experiences or a commitment to do so as a staff member at VCU.

Preferred Hiring Standards:

• Degree or equivalent experience in the sciences preferred.
• Healthcare experience preferred.
• Familiarity with RedCap, Microsoft Programs, EPIC and/or OnCore a plus.
• Familiarity with VCU Health preferred.
• Active clinical licensure such as CMA, CAN, EMT, RN, LPN.
• No prior experience required, but prior experience working in clinical research is preferred.

Position will remain open until filled.

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: $16-$26

Department: SOMCRO
Employment Type: H1 - Hourly
Restricted Status: No
FTE: 
Exemption Status: Non-Exempt

ORP Eligible: No

University Job Title: Clinical Research Coordinator 1-3 (34111N-34113N)

Contact Name: Liliana Valladares

Contact Email: Liliana.Valladares@vcuhealth.org