Senior Clinical Research Coordinator, School Of Medicine, Clinical Research Office

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 School of Medicine (SOM) Office of Research Administration is seeking a candidate with strong skills in clinical research coordination and management to join our clinical research organization (SOMCRO). SOM is committed to supporting VCU clinical researchers in advancing medical science in our region. Clinical research is a continually expanding area in healthcare. This is a team lead position with an opportunity to help build a team of clinical research professionals with advanced job responsibilities in acute care. This position provides an opportunity to work in a fast-paced environment with potential for career growth in the field of clinical research management for those presenting a willingness to learn and ability to work collaboratively with a diverse group of faculty and staff.

This position is a key part of the team focused on supporting SOM clinical investigators with activation and management of clinical trials in a positive and dynamic environment. This position reports to the Senior Program Manager of SOM Clinical Trials Coordination where key responsibilities include:

• Maintain an advanced understanding of clinical research management duties from study initiation to close-out.

• 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.

• Be directly responsible for study coordination and regulatory management of an assigned portfolio of clinical research studies covering a variety of diseases and conditions, including acute care.

• Serve as a senior research coordinator for an emerging central coordinator pool; work with leadership to lay the groundwork for expanding a coordinator pool overall portfolio staffing and management. Assume responsibility for oversight of additional CRC staff as support needs grow.

• Train clinical research staff in the growing SOM Research Coordinator pool; participate in the development and delivery of standard orientation and onboarding programs for CRCs school-wide.

• Serve as an ongoing resource for providing information and expert advice on clinical research issues.

• Lead the development of best practice guidance and work aids for CRCs in areas such as study activation, study coordination, data management, and records management.

• 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.

Core Responsibilities:

Responsibility 1 (5%): Accountability, empowerment, and excellence in customer service.

• Promote accountability by maintaining clear documentation of internal SOPs and working guidance as well as providing clear communications to our investigators and study sponsors. Understand the importance of ownership of tasks and responsibilities. Grow relationships with investigators and study sponsors, develop trust, deliver on the services we are to provide. Support study administrative activation and amendment processes, study coordination, right-size clinical research staffing, interface with VCUHS.

• 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.

• Manage study coordination activities for studies supported by a pool of clinical research coordinators or other study team personnel, ensuring transparency with investigators and others involved in study management.

• Communicate with clinical trial sponsors as appropriate, e.g., study activation responsibilities, essential document collection, and ongoing study management and coordination.

Responsibility 2 (35%): Clinical research coordination and management, including training, onboarding, and assistance for coordinator staff in the pool.

• Work with leadership to lay the groundwork for expanding the coordinator pool.

• Supervise junior CRCs as the pool expands; manage portfolios assigned to all CRCs on the team to ensure equitable workloads across the team.

• Assist management with developing standardized onboarding and training activities for new personnel in the pool. Ensure CRC training on all protocols assigned.

• Serve as an ongoing resource for providing information and advice on clinical research issues.

• Ensure timely and accurate data entry into OnCore.

• Serve as a role model to provide information, expert advice, and instruction to investigators, research nurses/coordinators, and research support staff for planning, development, implementation, conducting, monitoring, and termination of clinical research trials.

Responsibility 3 (60%): Perform study implementation and coordination tasks for studies assigned.

• Participate in the protocol feasibility process for new research studies placed with investigators. Review and evaluate protocols to identify issues, challenges, and potential problems related to subject recruitment and clinical issues; gather information for solutions; and determine whether the trial is appropriate to conduct at this institution.

• Work with the SOMCT administrative activation team; 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 procedures.

• Day-to-day clinical research management of assigned studies; study activation, regulatory, human subject protection, study recruitment/conduct, data management, study close-out.

• Review, understand, and champion trials in the portfolio. Proactively communicate with investigators for any gaps in understanding. Perform staff in-service/education for 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.

• Screen for potential research participants through the evaluation of inpatients and outpatients using inclusion/exclusion criteria and protocol-specified eligibility requirements.

• Coordinate with physician investigators to explain research studies to potential participants and ensure that informed consent is obtained prior to initiation of study-related procedures. Ensure proper administration/execution of informed consent and proper documentation. Ensure ongoing consent of study participants.

• Coordinate with physician investigators to monitor and manage patients' care on research protocols. Ensure protocol compliance. Maintain confidentiality.

• Collect, record, and maintain records of all data collected for research participants. Provide safekeeping of records during the study and for a designated period after study closure.

• Ensure timely and accurate data entry into OnCore (clinical trial management system) for both study level and participant level data for studies in the portfolio. Collaborate with financial personnel to ensure appropriate information is provided to manage the research budget.

• Prepare or assist with required regulatory and IRB ongoing study documentation, including annual progress reports, protocol amendments, and safety reports.

• Conduct all assigned activities in compliance with national, local, & institutional guidelines according to all HIPAA, GCP, and other applicable requirements.

• 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.

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

• Coordinate and organize the administrative activities related to the pre-study assessment visits, the study initiation visit, monitoring visits, and close-out activities. Participate in visits as appropriate.

• Create and maintain source documents, assuring the collection, recording, and maintenance of records for all data collected from research participants; and the collection of various laboratory specimens and performance of various medical procedures required by the research protocol. Ensure documentation of all study activity according to ALCOA standards (Attributable, Legible, Contemporaneous, Original, Accurate).

• Assist in resolving clinical, operational, and administrative problems related to studies in the portfolio.

• Participate in cross-training and cross-coverage for other members of the pool, ensuring no lapse in administrative aspects of study management or study conduct for studies managed by SOMCT.

• Occasional ability to shift schedule to provide on-call/after-hours coverage for research projects as needed.

• Complete VCUHS orientation and training modules as required for the department and clinical research projects. Conduct applicable clinical activities only as approved and required for each clinical research project. Follow all VCUHS requirements for training to acquire and maintain access to VCUHS clinical systems and clinical data. Any clinical skill conducted in VCUHS clinical areas requires VCUHS competency verification/documentation prior to performing each activity.

Minimum Hiring Standards:

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

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

• Strong communication 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 management; prior experience at an academic medical center strongly preferred.

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

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

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

Position will remain open until filled. This is a restricted position with no set end date and continued employment is dependent upon project need, availability of funding, and performance.

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.

VCU is committed to hiring veterans! VCU will include a veteran's period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!

Salary Range: Commensurate with experience

Department: SOMCRO

Employment Type: UF - University Employee FT

Restricted Status: Yes

FTE: 1

Exemption Status: Exempt

ORP Eligible: No

University Job Title: Sr Clinical Research Coordinator 1-3 (34114N-34116N)

Contact Name: Liliana Valladares

Contact Email: Liliana.Valladares@vcuhealth.org