Clinical Research Coordinator

Position Objective: The Clinical Research Coordinator will provide support services to satisfy the overall operational objectives of the National Institutes of Health (NIH), National Institute on Aging (NIA) within the National Institutes of Health.

Duties and Responsibilities:

• 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 1

• Review and Identify suitable applications for award to be classified as Clinical TrialCT, working to ensure all approved applications are correctly specified 2

• Report findings of CT applications, by developing summary statements to identify Human Subjects Concerns and request any necessary corrections from the applicant via email; 3

• Work with Clinical Trial Coordinator CTC to advise applicants that Authorized Organizational Representative AOR concurrence is required responses 4

• 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 review3 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 eg, DSMPDSMBmaterials, dissemination plan, compliance with single IRB policy, protocol

• Assist PI to register applications identified by NIA staff as approved for award inclinicaltrialsgov

• 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 clinicaltrialsgov ID number

• After an application is awarded by NIA : Collaborate with CTC to ensure review of regular data reports including unmasked data I 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: Assist PIs, AORs and DSMBs in the coding of adverse events using the latest version of the

• Medical Dictionary for Regulatory AffairsIe, communicate with PI to collect adverse events reported since last reporting period or since the study start, and resolve any PI queries

• 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

• Depending on the scientific focus of the project for awarded applications requiring aDSMB:

• 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 appropriate4

• Draft memo for PO approval and signature to the Director of NIA requesting approval of DSMB

• Contractor will 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 Contractor shall 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 Contractor shall 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 facet- 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

• Contractor shall update annual status of recruitment enrollment in NIH Human Subjects Reporting System

• If required by PO, contractor shall track recruitment more regularly eg, some projects may require monthly tracking

• Contractor shall review annual progress report of project If a project is on a quarterly reporting schedule, contractor shall closely monitor progress of such trials

• Contractor shall remain current on training specified by BSR, to include Good ClinicalPractice and Adverse Event training

• Contractor shall stay current on updates to relevant NIH and NIA policies, brief Divisionof Behavioral and Social Research BSR staff on updates, and ensure compliance with current policies

• Contractor shall 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 BSRproperty

• Contractor shall work with CTC and other support staff to maintain and organize an online resource of documentation regarding BSR clinical trials, including Standard5 Operating Procedure documents for all tasks related to BSR handling of clinical trials on the BSR eq

• SharePoint or SharedDrive

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; Clinicaltrialsgov Identifier number; Proposed and actual recruitment enrollment

• 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

Qualifications

Basic Qualifications:

• Master’s degree in Health and Medical Administrative Services or a related discipline.

• Skilled in MS Office Suite

Preferred Qualifications:

• Ability to communicate effectively, orally and in writing, with non-technical and technical staff

• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

* This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.

This position is contingent upon contract award.