Research Coordinator - DVAC

RESEARCH COORDINATOR–DVAC

This position is located at the Durham VA Medical Center and is part of the VISN6 Cancer Clinical Research Network (CCRN) Program. CCRN is a collaborative program between VA Office of Research and Development and the VA National Oncology Program to improve the care of Veterans with cancer and increase cancer clinical trials in the VA. The Durham VA Research Program Manager is responsible for managing the clinical-research program as part of the multi-site CCRN. The role of the Research Program Manager is to support and supervise all activities of the CCRN, provide procedural and regulatory knowledge, and support multiple research projects. The Research Program Manager performs a variety of complex tasks related to design, development, and implementation of research processes, and initiation and conduct of research protocols. This includes assessing feasibility of research studies, study initiation, subject recruitment and enrollment, data collection and review, sample collection, preparation, and shipping, regulatory tasks, financial oversight, national program building, and hiring assistance. The Research Program Manager works with others members of the research and clinical teams at the Durham VA and other VISN6 facilities, collaborators and supporting services at the Durham VAMC, research staff at other CCRN sites, and the national CCRN executive committee. These complex tasks directly impact the reputation of the CCRN program, both locally and nationally. The Research Program Manager is assigned to managing the CCRN program in VISN6, including decentralized and multi-site clinical trials and interfacility clinical programs. The Research Program Manager has knowledge of clinical trial activation and management, methods of program implementation and improvement, and conduct of human subject research. This includes the full scope of activities required to conduct clinical research, including study management, human subjects protection, and regulatory and policy compliance with the VA. The incumbent uses independent judgement to apply regulations to specific situations, monitors training and certifications of research team members, and advises investigators on research procedures specific to oncology clinical trials. The Research Program Manager provides expert advice to the Principal Investigator of the Durham CCRN site, the Durham research team, research staff at other VISN6 CCRN sites, and the executive committee of the CCRN program regarding study progress, obstacles and resolutions, and opportunities to improve study and program activities. The Research Program Manager prepares required reports as needed. Regular written and oral communication with the Durham VA research team and with research staff at other VISN6 CCRN sites through weekly in person meetings, regular emails, twice-monthly conference calls, and annual national meetings is obligatory.

MAJOR DUTIES AND RESPONSIBILITIES:

RESEARCH PROJECT ADMINISTRATION (40 Percent) Plan, develop, complete and submit documentation for initial and continuing review to IRBs. Analyze processes and documentation to ensure compliance with regulatory, privacy, and information security requirements for each individual clinical trial. Communicate with providers at other VA facilities in VISN6 regarding available clinical trials and potential research subjects. Develop and use evaluation metrics to improve recruitment and screening procedures. Evaluate data collection quality and establish and monitor remediation plans to correct deficiencies. Provide technical guidance to other members of research team regarding the conduct of human subjects research, including regulations, policies, and procedures. This may require researching and identifying individuals and written materials that serve as resources to be applied to the context of individual clinical trials. Independently respond to inquiries from research staff (locally and nationally) and other stakeholders. Independently correspond with others regarding the CCRN program and individual clinical trials, including memoranda and reports. Schedule meetings, arrange for space, notify participants, prepare agenda and minutes, and follow up. Assist local ACOS‑R, R&D service AO, and Research Budget Analyst in expensing and allocating VA CCRN research funds (from CSP). Assist staff at the Institute for Medical Research (IMR), the Durham VAMC affiliated non‑profit corporation in expensing and allocating non‑VA research funds. Research funds are to be expended in accordance with program goals and budgets/contracts. Manage subject compensation, maintain compensation records, and prepare invoices for reimbursement, as required by individual clinical trial budgets. Contribute to the development of local and national standard operating procedures and policies as they pertain to clinical trials and the CCRN program. Organize and maintain all required study specific documents, including regulatory and source documentation. Provide feedback to improve problem areas at the local and national levels as they pertain to the CCRN program and human subjects oncology clinical research. Monitor clinical trial progress and timelines. Establish and manage an electronic project tracking system, to assess and improve study timelines, from initiation to completion. Prepare and participate in meetings related to oncology clinical research and CCRN, which include weekly in person Durham research team meetings, every‑other‑week national CCRN conference calls, and annual in‑person CCRN annual meetings. Assist in hiring, writing Position Descriptions, performance‑based interviewing and selection of candidates in conjunction with the Principal Investigator. Assist in assessing feasibility of clinical research trials by reviewing protocols and discussing study procedures with clinical staff, including nurses, pharmacists, physicians, laboratory technologists, and other local staff. Track required training and certifications for study personnel and assure they are maintained and up to date. Prepare presentations for CCRN annual meeting and monthly CCRN conference call, as required by the program executive committee. CONDUCT RESEARCH (30 Percent) Initiate, carry out, and complete clinical trials in accordance with the study protocols. Prepare and submit regulatory documents to different agencies within a specified timeline. Review and prepare information related to privacy and information security that are study specific (e.g. websites and sponsor provided) and submit for approval by local and/or national privacy and information security officers. Work with members of the VA informatics and computing infrastructure (VINCI) to create pipelines for initial subject screening based on study‑specific eligibility criteria, and to identify potentially eligible research subjects. Screen potential research subjects to assess eligibility for clinical trials, using manual chart review. This involves working and communicating with other local research staff and oncology providers with knowledge of individual patients. Explain and educate potential research subjects regarding the nature and purpose of clinical research in general and specific clinical trials for which they are eligible. Obtain written informed consent and HIPAA authorization from eligible subjects. Assure required forms are complete, and work with study Principal Investigators to resolve problems related to accurate and appropriate completion of subject documentation. Prepare for, organize, and conduct research visits, as required by study protocols. This may include meeting and communicating with study subjects to assure required phlebotomy, biopsy, and/or imaging studies are completed, collecting data from subjects (e.g. medication reconciliation, adverse event), communicating with the investigational pharmacist and chemotherapy nurse to assure appropriate treatment is administered, and instructing providers and/or investigators as to required visit‑specific procedures that must be completed and documented. Prepare and participate in audits and monitor visits, for compliance with the sponsors, R&D and IRB, and NCI cooperative groups, as needed. Prepare follow up memoranda or minutes as required, and complete recommendations provided by monitors and auditors. Conduct studies in accordance with Good Clinical Practice, and other required standards for human subjects research as required by the VA. DATA COLLECTION (30 Percent) Collect baseline/screening data, communicate with research team and study subject to assure baseline and screening procedures are completed within the required window. Enter required data into study‑specific electronic data capture (EDC) system and randomization system (if applicable). Extract and review data from research subjects’ medical records and enter into EDC in timely fashion, as required by specific clinical trials. Collect, prepare according to study protocol, and ship samples (e.g. urine, blood, bone marrow, tumor) to study sponsor, as required by specific clinical trials, using methods approved by local and/or national information security officers. Collect, prepare, and ship imaging to study sponsor as required by specific clinical trials. Prepare personal health information (PHI) redacted imaging reports, and submit via EDC systems, as required. Assess for serious and non‑serious adverse events and communicate them in the required timeframe with the study sponsor and IRB using established documentation. Monitor data collection processes to ensure data integrity and completeness. Communicate with other CCRN sites to address inquiries related to data collection and submission. Ensure data collection and transmission activities are compliant with applicable information security and privacy policies. Performs other duties as assigned. Salary Range: $90,000 - $100,000 - Salary will be commensurate with experience level. This position is primarily in‑person and candidates must be available to work Monday‑Friday. Expected start date is typically 5‑6 weeks following job offer and is contingent upon completion and processing of VA paperwork. IMR offers a competitive benefits package which includes health, dental, vision and life insurance, a matching 403b retirement savings plan, and paid holiday, vacation, and sick leave. All IMR employees are required to obtain a WOC appointment at the DVAHCS. As a result, the successful candidate must undergo a federal background check and may be subject to a drug test. IMR employees must reside in the state of North Carolina. We will not sponsor applicants for work visas. Participation in the seasonal influenza and Coronavirus Disease 2019 (COVID‑19) Vaccination programs may be requirements for all Department of Veterans Affairs Health Care Workers Without Compensation (WOC). Equal Opportunity Employer, including disabled persons and veterans. Accessibility: The Institute for Medical Research endeavors to make the online application process accessible to any and all users. If you would like to contact us regarding the accessibility of our website, or need assistance completing the application process and/or accommodation as part of the employment process, please contact Human Resources. Phone: View phone number on click.appcast.io Email: View email address on click.appcast.io This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. #J-18808-Ljbffr Institute For Medical Research, Inc.