Clinical Research Operations Manager Jobs in Virginia

A Clinical Research Nurse (CRN) supports Principal Investigators (PI) in the day-to-day activities required for activation, execution, and management of clinical research studies or protocols. Active clinical licensure is required for duties expected to be directly performed by the Clinical Research Nurse. At Massey, the CRN has more complex and intensive participant contact in a clinical setting requiring an individual with high levels of clinical competency to perform the research related study work. In addition to performing clinical skills associated with research studies, typical duties of a CRN include but are not limited to: assist the PI in assessing study feasibility, determining participation eligibility, and establishing guidelines for clinical data collection; serve as patient/participant recruiters; and perform a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. A CRN may work independently or as a member of a team. They work under general supervision, resolving most standard issues independently and referring complex issues to an upper-level manager or the PI, as appropriate. This role reports in-person in downtown Richmond with the flexibility to work hybrid 5 days/month post-review, 3-6 months training and manager approval. Each CRN reports to a Clinical Operations Manager who oversees disease working group specific teams within the Clinical Research Operations Unit.

Recruitment, Enrollment, Retention, and Data Collection: A CRN drives study coordination and regulatory management with participant recruitment, enrollment, tracking, data collection, data processing/resolution (discrepancies, queries etc.), verification, case-finding, evaluation, abstraction of source documentation, case report form completion, database use/management, data abstraction/organization and archiving of data in the study database for research studies. A CRN leads development of best practice guidance and work aids for their respective research team for all data management documentation following standard practice guidelines, utilizing multiple data capture/retrieval systems & interacting with a variety of health care delivery systems to identify, track, evaluate, collate, analyze/submit subject data. Data may include but is not limited to paper data, electronic data & biological specimens.

Serve as a lead research coordinator for an emerging central coordinator pool, work with leadership to lay the groundwork for expanding a coordinator pool, and overall portfolio staffing and management;

Maintain advanced understanding of clinical research management duties from initiation to closeout including but not limited to: federal and state laws and regulations, sponsor guidance as well as university policies and compliance notices, with ability to consistently interpret and apply accurately;

Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as well as any other mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training as required;

Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols;

Follow VCU internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards, institutional operational research objectives are met and ethical obligations are kept;

Serve as an ongoing resource providing information and expert advice on clinical research for the research team including but not limited to the clinical study team coordinator, peer Clinical Research Nurses, Clinical Research Coordinators, Clinical Data Manager, Sponsors and PI with other duties as assigned.

Minimum Qualifications:

• Bachelor's degree in Nursing and active clinical RN licensure;
• 2+ years of relevant experience supporting data management activities with an exposure to data processes and flow or equivalent combination of education, training, and experience with the ability to learn basic data entry, understand complex protocols and motivation to learn the foundation of at least one oncology disease area;
• 2+ years of experience with various clinical research or healthcare technologies including but not limited to: EDC software, XML, OnCore, EMR (Cerner or EPIC), RedCap, DEEP6A;
• Advanced proficiency with Microsoft Excel, Word, Access, Outlook, Visio, Smartsheets and Adobe with the ability to adapt to a range of database applications;
• Interest in working in a fast paced, demanding environment and adapt to changing client status, regulations and work environment;
• 2+ years' of demonstrated professional knowledge of medical, oncology, clinical research and/or disease working group terminology;
• Ability to provide own transportation to meet with patients within the service area (Downtown Richmond, Stoney Point, etc.) and attend all meetings within service areas and at training locations.

Preferred Qualifications:

• Master's degree or equivalent combination of education, experience, and training;
• 3+ years of relevant experience supporting data management activities with an exposure to data processes and flow or equivalent combination of education, training, and experience with basic data entry, complex protocols and the foundations of at least one oncology disease area;
• 1+ years' experience with research studies, interpreting complex protocols, subject records and federal, state, local regulations;
• 1+ years current knowledge of oncology, cancer treatment and care;
• 3+ years evidence of effective communication with research participants and/or patients on clinical trials;
• Collaborative Institutional Training Initiative (CITI) Training or knowledge of regulations regarding the use of human subjects in clinical trials, outcomes research, nursing research, and other research areas or equivalent combination of education, experience, and training;
• Certification from the Society of Clinical Research Associates (SOCRA), the Association of Clinical Research Professionals (ACRP) or CRA certification for Research Administration.

Salary Range: Commensurate with experience, range minimum of $68,000

FLSA Exemption Status: Exempt

Restricted Position: No

ORP Eligible: No

Flexible Work Arrangement: Hybrid

University Job Title: 93408 - Open

Contact: MasseyHR@vcu.edu