Clinical Research Coordinator

Massey Comprehensive Cancer Center

Clinical Research Coordinators (CRC) support Principal Investigators (PI) in the day to day activities required for activation, execution, and management of clinical, patient-oriented research studies or protocols. Typical duties of a Clinical Research Coordinators include but are not limited to: assisting the PI in assessing study feasibility, determining participation eligibility, and establishing guidelines for clinical data collection; serving as patient/participant recruiter; and performing a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. CRCs coordinate the evaluation, treatment and follow-up of clinical trial candidates and participants in inpatient and ambulatory settings, educating staff at local and partner sites about clinical trials and related patient care while consulting with physicians/staff about patient care issues. This role includes responsibilities of the CRC to work independently and as a member of a team. Working under general supervision, a CRC resolves most standard issues independently and refers complex issues to an upper-level manager or the PI, as appropriate. This role reports in-person in downtown Richmond or Stoney Point with the flexibility to work hybrid 5 days/month post-review, 3-6 months training and manager approval. Each CRC 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 CRC 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 CRC leads development of best practice guidance and work aids for CRCs 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.

• Engage in various forms of communication about the studies they are assisting; engage in effective communication with the study's Hub Site, community partners, community organizations, social media outlets, research participants, and others;
• Work collaboratively and independently to develop electronic clinical research charts, conduct data retrieval, entry and quality control using eMR, CTMS (OnCore), other IT system and supporting documentation;
• Ensure trial visits, data for study participant tests and samples are done per the study schedule and entered in a timely fashion;
• 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;
• 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;
• 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;
• 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, Clinical Research Nurse, peer Clinical Research Coordinators, Clinical Data Manager, Sponsors and PI with other duties as assigned.

Minimum Qualifications

• Bachelor’s degree in health research and/or healthcare-related fields or equivalent combination of education, experience, and training;
• 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 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.

Candidates whose resumes highlight the following previous experience will be prioritized:

• Demonstrated experience working in and fostering an environment of respect, professionalism and civility with a population of faculty, staff, and students from various backgrounds and experiences, or a commitment to do so as a staff member at VCU;
• Advanced proficiency with data entry and word processing skills, with the ability to analyze and interpret information effectively;
• Advanced organizational abilities and a keen eye for detail to ensure accuracy and efficiency in all tasks with the ability to multitask and prioritize autonomously;
• Clear and professional written and verbal communication skills, with the ability to interact effectively with colleagues and stakeholders;
• Interpersonal skills, capable of building relationships and collaborating with team members at all levels to gather information and support compliance efforts;
• Problem-solving and organizational aptitude, with the ability to manage multiple tasks, meet deadlines in a dynamic environment and independently make critical decisions.

Please note VCU is not able to provide ongoing visa sponsorship for this position.