Clinical Research Coordinator

Axle•Bethesda, MD

23h•$135,000 - $145,000•Onsite

About The Position

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. They work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Axle is seeking a Clinical Research Coordinator to join their team at the National Institutes of Health (NIH) supporting the National Institute on Aging (NIA) located in Bethesda, MD. The primary objective of this position is to provide support services to satisfy the overall operational objectives of the National Institutes of Health (NIH), National Institute on Aging (NIA) through performance of support services and deliverables.

Requirements

Degree in a related discipline (Field of Study Health and Medical Administrative Services General Medical and Health Services)
MS Office Suite skills
Strong oral and written communications skills

Responsibilities

Work products and documents related to providing lists of applications approved for award that are classified as Clinical Trials (CTs)
Work products and documents related to providing lists of CT applications that require risk assessment
Work products and documents related to providing lists of CT applications that meet NIA criteria requiring a Data and Safety Monitoring Board (DSMB)
Work products and documents related to completed checklists used to review DSMBs
Work products and documents related to track receipt of DSMB signed Conflict of Interest and Confidentiality statements and required DSMB materials
Work products and documents related to tracking documents showing status of stages of compliance
Work products and documents related to lists of coded adverse events
Work products and documents related to draft emails and memos and minutes of DSMB meetings and BSR communications.
Provide administrative and management support of experimental studies with human subjects and the appropriate conduct of behavioral interventions on individuals, communities, and populations for applications identified by NIA staff as being considered for award
Review and Identify suitable applications for award to be classified as Clinical Trial CT, working to ensure all approved applications are correctly specified
Report findings of CT applications, by developing summary statements to identify Human Subjects Concerns and request any necessary corrections from the applicant via email
Work with Clinical Trial Coordinator CTC to advise applicants that Authorized Organizational Representative AOR concurrence is required on responses
Supports clinical staff develop, implement and maintain clinical research data files and materials.
Identify applications that meet the NIA criteria requiring a Data and Safety Monitoring Board DSMB
For CT applications that require a DSMB, work with CTC to inform applicant via email of NIH and NIA policies for clinical trials, attach relevant, current templates and request all appropriate information, with AOR concurrence required in response; which include but not limited to Data and Safety Monitoring Plan DSMP, Information on DSMB including membership contact information
For applications identified by NIA staff as approved for award the contractor shall take actions prior to award including but not limited to: Working with CTC to review Data Safety Monitoring Plan DSMP using the NIA provided DSMP checklist and assessing whether it appropriately addresses all required safety and monitoring issues, and consistency with NIA and NIH policies
Assist Principal Investigators PIs in revising DSMPs to be consistent with policies
Advise Project officer PO of exceptions to get PO approval to move forward
Track compliance with NIHNIA policies for applications identified by NIA staff as approved for award, including whether a risk assessment has been completed, final documentation has been received and which is outstanding e.g., DSMPDSMB materials, dissemination plan, compliance with single IRB policy, protocol
Assist PI to register applications identified by NIA staff as approved for award in clinicaltrials.gov
Review Project Management Module PMM and Human Subjects Systems HSS for target enrollment and document the linkage between subject clinical trial within a project, their respective inclusion enrollment tables, and the clinical trials gov ID number
After an application is awarded by NIA: Collaborate with CTC to ensure review of regular data reports including unmasked data if needed on adverse events
Document and advise PO of response resolution PO review is required
After an application is awarded by NIA: Draft emails for PO approval and signature requesting additional data from investigators with AOR concurrence on safety or other issues arising during the project
After an application is awarded by NIA: On a weekly basis, provide the list of coded adverse events to the PO and CTC
For awarded Applications, requiring a DSMB: The contractor shall provide administrative support services to PO specific to NIA appointed DSMBs
For awarded applications requiring a DSMB: Assist PO with assessments, recommendations, and general support in establishing the DSMB
Review the proposed DSMBs to determine compliance with current and relevant NIH and NIA policies and whether the DSMB includes sufficient appropriate expertise
Track receipt of DSMB signed Conflict of Interest and Confidentiality statements and required DSMB materials
Recontact PI weekly until all required documentation has been received
Notify the PO when all DSMB materials are received and complete and are ready for POs approval, subject to NIA Directors approval
Prepare emails for PO approval and signature to communicate any concerns regarding the proposed DSMB with the PI, and request DSMB modifications as appropriate
Draft memo for PO approval and signature to the Director of NIA requesting approval of DSMB
Coordinate with CTC to request services such as power analysis if requested by DSMB or PO
Coordinate scheduling of PO availability for DSMB meetings, prepare calendar appointments, and make sure PO has all relevant materials prior to meetings
If required by the PO, contractor shall take minutes of DSMB calls
Alert PO to any issues, including adverse events, immediately upon conclusion of the call
Within two business days of a call contractor shall submit minutes in electronic format to PO and DSMB chair
Maintain records of DSMB approval of the minutes and of DSMB recommendations; keep a log of adverse events; follow up on action items from the call, including ensuring that the PI has contacted their IRB if there are changes to the trial protocol
Identify any issues related to delayed-onset clinical trials and make recommendations to the PO to ensure that all documentation submitted by the PI with AOR concurrence is complete and in compliance with NIH and NIA policies
Work with CTC to compile a list of grants requiring a DSMB
Work to obtain Clinical Research Liability Insurance covering professional and general liability including punitive damages for the DSMB members
For NIA-appointed DSMBs that monitor multiple NIA grants, contractor will coordinate with CTC to ensure logistical support for face-to-face meetings: schedule meeting dates and locations; arrange flight reservations, lodging, and transportation; write meeting minutes and reports; communications and on-site support during the meeting
Update annual status of recruitment enrollment in NIH Human Subjects Reporting System
If required by PO, contractor shall track recruitment more regularly e.g., some projects may require monthly tracking
Review annual progress report of project
If a project is on a quarterly reporting schedule, contractor shall closely monitor progress of such trials
Remain current on training specified by BSR, to include 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 with current policies
Schedule bi-weekly meetings with POs to report on progress, consider concerns, advise on updates to policies, and other relevant topics
At least one business day in advance of meeting contractor will provide written agenda to POs
Create and communicate plans and templates for processes, which will remain BSR property
Work with CTC and other support staff to maintain and organize an online resource of documentation regarding BSR clinical trials, including Standard Operating Procedure documents for all tasks related to BSR handling of clinical trials on the BSR eq SharePoint or Shared Drive SharePoint or Shared Drive, to include: Approved protocols; Risk Assessments; Approved DSMPs; Approved DSMBs membership; Approved DSMB charters; Approved DSMB minutes and meeting materials; DSMB insurance policy amendment; Clinical trials gov Identifier number; Proposed and actual recruitment enrollment
Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations.
Collects research data and prepares information for inputs and analysis.
Supports the development of forms and questionnaires.
Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
Assist PIs, AORs and DSMBs in the coding of adverse events using the latest version of the Medical Dictionary for Regulatory Affairs, communicate with PI to collect adverse events reported since last reporting period or since the study start, and resolve any PI queries
Monitors subject's progress and reports adverse events.
Supports assembly, development and review of new research projects.
Supports the creation and management of clinical websites and web-based tools.
Organizes and performs clinical research, utilizing internet and other available clinical resources.
Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.
Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.