Clinical Research Coordinator

Axle•Bethesda, MD

16h•Onsite

About The Position

Axle is a bioscience and information technology company specializing in translational research, biomedical informatics, and data science. They partner with leading research organizations, including the National Institutes of Health (NIH). Axle is seeking a Clinical Research Coordinator to join their team at the National Institutes of Health (NIH), specifically supporting the National Institute on Aging (NIA) in Bethesda, MD. This role involves providing comprehensive support services to meet the operational objectives of NIH/NIA, with a focus on managing and coordinating clinical trials, conducting risk assessments, overseeing Data and Safety Monitoring Boards (DSMBs), and ensuring compliance with relevant policies and regulations.

Requirements

Degree in a related discipline (Health and Medical Administrative Services, General Medical and Health Services).
Proficiency in MS Office Suite.
Strong oral and written communications skills.
Current on Good Clinical Practice training.
Current on Adverse Event training.

Responsibilities

Provide administrative and management support for experimental studies involving human subjects and behavioral interventions for applications identified by NIA staff for award consideration.
Review and classify suitable applications for award as Clinical Trials (CTs), ensuring accurate specification of all approved applications.
Report findings of CT applications by developing summary statements to identify Human Subjects Concerns and request necessary corrections from applicants via email.
Collaborate with the Clinical Trial Coordinator (CTC) to inform applicants that Authorized Organizational Representative (AOR) concurrence is required on responses.
Support clinical staff in developing, implementing, and maintaining clinical research data files and materials.
Identify applications that meet NIA criteria requiring a Data and Safety Monitoring Board (DSMB).
For CT applications requiring a DSMB, work with the CTC to inform applicants via email about NIH and NIA clinical trial policies, provide relevant templates, and request all appropriate information (e.g., Data and Safety Monitoring Plan (DSMP), DSMB membership contact information), requiring AOR concurrence.
For applications approved for award by NIA staff, review the Data Safety Monitoring Plan (DSMP) using the NIA-provided checklist, assessing its appropriateness and consistency with NIA and NIH policies.
Assist Principal Investigators (PIs) in revising DSMPs to align with policies.
Advise the Project Officer (PO) of any exceptions to obtain PO approval to proceed.
Track compliance with NIH/NIA policies for approved applications, including completion of risk assessments, receipt of final documentation (e.g., DSMP/DSMB materials, dissemination plan, single IRB policy compliance, protocol).
Assist PIs in registering approved applications in clinicaltrials.gov.
Review the Project Management Module (PMM) and Human Subjects Systems (HSS) for target enrollment and document the linkage between subject clinical trials, inclusion enrollment tables, and the clinicaltrials.gov ID number.
After an application is awarded by NIA, collaborate with the CTC to ensure regular review of data reports, including unmasked data if necessary, on adverse events.
Document and advise the PO on response resolution, requiring PO review.
After an application is awarded by NIA, draft emails for PO approval and signature to request additional data from investigators with AOR concurrence on safety or other issues.
After an application is awarded by NIA, provide a weekly list of coded adverse events to the PO and CTC.
For awarded applications requiring a DSMB, provide administrative support services to the PO specific to NIA-appointed DSMBs.
Assist the PO with assessments, recommendations, and general support in establishing the DSMB.
Review proposed DSMBs to ensure compliance with current NIH and NIA policies and sufficient appropriate expertise.
Track receipt of DSMB signed Conflict of Interest and Confidentiality statements and required DSMB materials, recontacting PIs weekly until all documentation is received.
Notify the PO when all DSMB materials are received, complete, and ready for PO's approval, subject to NIA Director's approval.
Prepare emails for PO approval and signature to communicate concerns regarding the proposed DSMB with the PI and request DSMB modifications.
Draft memos for PO approval and signature to the Director of NIA requesting approval of the DSMB.
Coordinate with the CTC to request services such as power analysis if requested by the DSMB or PO.
Coordinate scheduling of PO availability for DSMB meetings, prepare calendar appointments, and ensure the PO has all relevant materials.
If required by the PO, take minutes of DSMB calls, alert the PO to any issues (including adverse events) immediately, and submit minutes in electronic format within two business days.
Maintain records of DSMB approval of minutes and recommendations, keep a log of adverse events, and follow up on action items from calls.
Identify issues related to delayed-onset clinical trials and make recommendations to the PO to ensure complete and compliant documentation submitted by the PI with AOR concurrence.
Work with the CTC to compile a list of grants requiring a DSMB.
Work to obtain Clinical Research Liability Insurance covering professional and general liability for DSMB members.
For NIA-appointed DSMBs monitoring multiple NIA grants, coordinate with the CTC to ensure logistical support for face-to-face meetings (scheduling, travel arrangements, minutes, reports, communications, on-site support).
Update annual status of recruitment enrollment in the NIH Human Subjects Reporting System.
If required by the PO, track recruitment more regularly (e.g., monthly).
Review annual progress reports of projects.
If a project is on a quarterly reporting schedule, closely monitor the progress of such trials.
Remain current on training specified by BSR, including Good Clinical Practice and Adverse Event training.
Stay current on updates to relevant NIH and NIA policies, brief Division of Behavioral and Social Research (BSR) staff on updates, and ensure compliance.
Schedule bi-weekly meetings with POs to report on progress, discuss concerns, advise on policy updates, and other relevant topics, providing a written agenda in advance.
Create and communicate plans and templates for processes, which will remain BSR property.
Work with the CTC and other support staff to maintain and organize an online resource of documentation regarding BSR clinical trials (e.g., SharePoint or Shared Drive), including approved protocols, risk assessments, DSMPs, DSMBs, minutes, insurance policy amendments, clinicaltrials.gov ID numbers, and recruitment enrollment data.
Instruct data entry and clinical staff in procedures related to data management, protocol instructions, Standard Operating Procedures, and regulatory processes.
Collect research data and prepare information for inputs and analysis.
Support the development of forms and questionnaires.
Support the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
After an application is awarded by NIA, assist PIs, AORs, and DSMBs in coding adverse events using the latest version of the Medical Dictionary for Regulatory Affairs, communicate with PIs to collect adverse events, and resolve queries.
Monitor subjects' progress and report adverse events.
Support the assembly, development, and review of new research projects.
Support the creation and management of clinical websites and web-based tools.
Organize and perform clinical research, utilizing internet and other available clinical resources.
Provide assistance to staff in the collection, development, and quality control of essential clinical research efforts.
Develop and facilitate training for new research coordinators and mentor researchers in Good Clinical Practices.