Virginia Commonwealth University Richmond , VA 23234
Posted 2 months ago
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 and Primary Responsibilities:
The School of Medicine (SOM) Clinical Research Office (CRO) is seeking a candidate with strong skills in clinical research coordination and regulatory management to join our team as a Clinical Research Regulatory Coordinator. This position is a key part of the team focused on supporting SOM clinical research study teams with the management of clinical trials in a positive and dynamic environment. The SOM is committed to supporting clinical researchers in advancing medical science in our region. Working under the direction of the Associate Director for Clinical Research Operations, key responsibilities for this position include:
Core Responsibilities:
Responsibility 1 (60%): Regulatory Management and Study Activation
Provide direct regulatory management for assigned SOM Clinical Trials
Maintain and organize regulatory documents for SOMCRO studies
Prepare and manage IRB documents and protocols for submission
Ensure regulatory compliance
Possess knowledge of and experience working within FDA guidelines
Act as liaison between Regulatory Bodies, VCU, and the SOM personnel
Possess knowledge of GCP/ICH guidelines
Ensure adherence to all human subject protection and IRB regulations required for clinical research
Understand duty to report obligations related to research conduct
Familiar with IRB (and Advarra, WIRB, as applicable) to be able to assist with submissions
Keeps PI and leadership informed regarding study regulatory operations and activation progress
Ensures that study startup is carried out according to sponsor/funding agency requirements
Obtains all required internal approvals (ie: SOMCT, OSP, etc.)
Follow all VCU and School of Medicine procedures for activation and management of clinical research
Responsible for ensuring clinical trials are initiated in Veeva SiteVault for e-Regulatory requirements
Responsibility 2 (20%): Support and Assist SOM Study Teams
Provide education and guidance to investigators as it relates to regulatory compliance
Work with SOMCRO Training Coordinator to develop tools that align with regulatory requirements
Coordinate site selection visits and study selection activities for assigned studies.
Ensure OnCore study team task lists are current throughout the activation process.
Participate in SOM pre‐study planning meetings and follow‐up action items.
Complete PROC and intake forms for studies assigned from initiation
Keep PI and study team informed regarding study regulatory operations and activation progress.
Coordinate with PIs to support the development of coverage analysis, budget and time/effort estimates
Stay up to date on internal clinical trial submission policies and educate study teams on changes.
Assist with training CRCs on required regulatory and IRB ongoing study documentation
Responsibility 3 (10%): Establish Standard Operating Procedures to support Regulatory Compliance
Create Standard Operations Procedures that align VCU Clinical Research Regulatory best practices
Ensure compliance with School of Medicine policies and procedures
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.
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.
Responsibility 4 (10%): Excellence in Customer Service and Collaboration
Provide ongoing support for clinical research operations and administration in SOM including ongoing communication with departments/divisions, investigators, administrators, and staff.
Work in collaboration with the SOMCTC Senior Program Manager to develop tools for centralized staff
Serve as an ongoing resource for providing information and expert advice on regulatory compliance.
Regularly assess VCU SOM CRC performance by performing quality control check
Minimum Hiring Standards:
Demonstrated knowledge of federal regulations as well as protection of human subjects and HIPAA
Must have ability to analyze, interpret, and implement complex Federal, State, and sponsor regulations
Must be knowledgeable of GCP/ICH guidelines for clinical studies.
Bachelor's degree or equivalent experience
At least 2 years of direct Clinical Research Coordinator experience.
1 or more years' experience in Clinical Research Regulatory affairs.
Demonstrated understanding of clinical research including all types and funding sources
Maintain CITI credentials for Human Subjects Protection and Good Clinical Practice (GCP)
Excellent oral and written communication skills
Must possess the ability to set priorities, make timely decisions and meet deadlines.
Ability to work collaboratively in a large and complex organization.
Comfortability working in and fostering a diverse faculty, staff, and student environment
Extremely organized and detail-oriented
Strong communications skills, attention to detail and time management skills
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:
Regulatory management of multi-site studies strongly preferred
Clinical research certification or ability to obtain.
Experience in an academic medical center environment.
Prior experience using OnCore or other clinical trial management systems preferred.
Advanced degree in healthcare, research, or education.
Knowledge of VCU and/or VCU Health
Experience utilizing EPIC (Electronic Medical Record)
Proficient with Microsoft Office Suite
Active clinical research certification, e.g., SOCRA, ACRP, or ability to obtain certification.
Position is remote-hybrid eligible (40%-60% remote work). Selected candidate must be able to come into the office on VCU's MCV-Health Campus when needed as office days may vary weekly.
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.
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: SOM CRO
Employment Type: UF - University Employee FT
Restricted Status: No
FTE: 1
Exemption Status: Exempt
ORP Eligible: No
University Job Title: Clinical Research Coordinator 1-Sr Clinical Research Coordinator Licensed 3 (34111N-34086N)
Contact Name: Liliana Valladares
Contact Email: Liliana.Valladares@vcuhealth.org
Virginia Commonwealth University