Clinical Research Coordinator
University Code 34111 University Title Clinical Research Coordinator 1 University Job Family Research - Support ORP Eligible No For more information on ORP, visit: Retirement Plans
Recruitment Pool All Applicants Recruitment Type Multi Title Scope of Search Local Working Title Clinical Research Coordinator Position Number 591310 Is this employee on a H1B Visa? Position Type Staff Job Status Full-Time FLSA Indicator Exempt Employee Group University Employee Department Physical Medicine & Rehabilitation Organizational Overview
At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.
Position Primary Purpose and General Responsibilities
For all clinical research studies assigned, the Clinical Research Coordinator is responsible for coordinating clinical research studies in a compliant and efficient manner. Under the direction of the Principal Investigator (PI), the incumbent will collaborate with all members of the clinical research team to ensure all federal, state, university, and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept. Activities include coordinating: screening/enrolling participants, regulatory and compliance requirements, maintaining appropriate study documentation/records, and managing study data.
Key responsibilities include:
• Ensure all Institutional Review Board ( IRB ) submissions are complete and submitted on time.
• Understand and adhere to all IRB requirements, Human Subjects protection regulations and all aspects of IRB approved protocols.
• Recruit, screen, and consent research participants and ensure compliance with IRB approved protocols as well as formulating study guidelines and responding to requirements of regulatory agencies.
• In conjunction with other research staff, formulate guidelines for the collection of clinical data and administration of studies. Coordinate and implement procedures for data collection.
• Coordinate and enable the collection, compilation, documentation, and analysis of research data from clinical trials and observational studies.
• Help principal investigators and other research staff to track, identify and report adverse events and protocol deviations. Ensure patient safety is a top priority in conducting clinical trials.
• Maintain regulatory binders in audit ready state- ensuring all documentation is complete and has been submitted to the IRB .
• In collaboration with research staff, evaluate and interpret data to ensure the successful completion of research projects.
• Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice ( GCP ), Clinical Research Coordinator, plus additional sponsor GCP certifications as required.
• Conducts all assigned activities in compliance with national, local, and institutional guidelines, according to all HIPAA, GCP, and other applicable requirements.
Minimum Hiring Standards
• Bachelor’s Degree.
• Experience as a Clinical Research Coordinator or completion of a clinical research certificate program.
• Demonstrated understanding of clinical research management duties from study initiation to close-out (regulatory, human subject’s protection, study conduct, and data management requirements).
• Demonstrated flexibility in terms of working with scholars and participants from various diverse backgrounds and personal experiences. Ability to work collaboratively and effectively in a diverse environment.
• Exhibits professionalism and ability to work both independently and collaboratively as part of a team; establishing and maintaining productive relationships with VCU colleagues and all customers and contacts necessary to effectively support research studies.
• Must be able to prioritize work requirements and multi-task in a fast-paced environment, seeking guidance from Principal Investigators and senior study team staff when necessary.
• Proficiency using Microsoft Office Suite products.
• Excellent communication, writing, critical thinking, and interpersonal skills.
• Ability to read, interpret, and apply complex regulations, policies, and requirements for each study assigned.
• Ability to manage time effectively, perform daily tasks with minimal supervision.
• Experience with interviewing individuals through previous employment, academic assignments, or community organization involvement.
• Experience with managing confidential personal information such as patient health information.
• Familiarity with SPSS and/or REDCap database entry and management.
• Reliable transportation and willingness to travel to study sites and meeting locations, as applicable.
Preferred Hiring Standards
• Master’s degree in Public Health, Psychology, Social Work, or a related field.
• Experience working with participants and scholars in a clinical research, academic or medical setting.
• Experience working with individuals who have disabilities.
• Experience with grant proposal development, writing, and submission.
Required Licenses/ Certifications
• Complete VCUHS orientation and training modules as required for the department & clinical research projects.
• Conduct applicable clinical activities only as approved & 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.
• Must maintain CITI certification.
• Must maintain all required VCU and VCUHS competencies related to performing research-related clinical skills.
• Job duties may include handling, transportation, access to and/or contact with medications and related supplies.
• This position does not perform tasks that require clinical licensing to perform.
Anticipated Hiring Range up to $60,000 Application Process/Additional Information Campus MCV Campus Hours/Week M-F 8-4:30 Normal Work Days/Hours 40 Job Open Date 03/19/2021 Posting will close on or before Open Until Filled Yes Job Category Research Is this a restricted position? Yes Is this position eligible to participate in alternative work arrangements? Yes Sensitive Position Yes- A pre-employment fingerprint background check will be required. Resource Critical No Quick Link https://www.vcujobs.com/postings/102345 Posting Specific Questions
Required fields are indicated with an asterisk (*).
Optional & Required Documents
Required Documents Optional Documents
- Cover Letter/Letter of Application