Apply on Employer Site

VCU Massey Comprehensive Cancer Center · 3 weeks ago

Clinical Research Coordinator, Clinical Operations, Restricted

Richmond, VA

Full-time

Hybrid

Entry, Mid Level

2+ years exp

VCU Massey Comprehensive Cancer Center is dedicated to reducing cancer burdens through impactful research and patient care. The Clinical Research Coordinator (CRC) supports Principal Investigators in managing clinical research studies, handling participant recruitment, data collection, and compliance with regulatory standards.

Clinical TrialsEducationHealth CareMedicalNon Profit

No H1B

Responsibilities

Assisting the PI in assessing study feasibility, determining participation eligibility, and establishing guidelines for clinical data collection

Serving as patient/participant recruiter

Performing a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data

Coordinating 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

Working independently and as a member of a team

Resolving most standard issues independently and referring complex issues to an upper-level manager or the PI, as appropriate

Driving 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

Leading 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

Engaging in various forms of communication about the studies they are assisting; engaging in effective communication with the study's Hub Site, community partners, community organizations, social media outlets, research participants, and others

Working 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

Ensuring trial visits, data for study participant tests and samples are done per the study schedule and entered in a timely fashion

Maintaining 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

Following 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

Maintaining 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

Understanding and adhering to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols

Serving 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

Qualification

Clinical Research ManagementData ManagementOncology KnowledgeEDC SoftwareMicrosoft ExcelCITI CertificationCommunication SkillsOrganizational SkillsProblem-Solving SkillsInterpersonal Skills

Required

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

Preferred

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

2+ years experience working with underrepresented populations and in communities

Previous phlebotomy training/certificate, Certified Medical Assistant and/or willingness to be trained in phlebotomy

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

Benefits

Comprehensive health benefits

Paid annual and holiday leave granted up front

Generous tuition benefits

Retirement planning and savings options

Tax-deferred annuity and cash match programs

Employee discounts

Well-being resources

Abundant opportunities for career development and advancement

Up to 5 remote days per month upon successful completion of training and leadership approval

Continuing education for undergraduate and graduate tuition for a maximum of 6 credits per semester

Professional development opportunities encouraged and offered for employees as part of annual career development, e.g. certifications, seminars, courses, annual conferences, mentorship

28 Vacation Days

12+ State Holidays

4 Days to volunteer

Medical, Dental and Vision Health Benefits to meet the needs of employees and their eligible family members from the Commonwealth of Virginia as well as optional FSA

Participation in the Virginia Retirement System (VRS) and other retirement saving options

Parental and Caregiver Leave

Short Term Disability (STD)

Disability Insurance

Voluntary Long Term Care Insurance

Employee Assistance Program