Clinical Research Coordinator

Deliverables:

• Work products and documents related to providing lists of applications approved for award that are classified as Clinical Trials (CTs) Ad-HocWork products and documents related to providing lists of CT applications that require risk assessment - Ad-Hoc

• Work products and documents related to providing lists of CT applications that meet NIA criteria requiring a Data and Safety Monitoring Board (DSMB) - Ad-Hoc

• Work products and documents related to completed checklists used to review DSMBs - Ad-Hoc

• Work products and documents related to track receipt of DSMB signed Conflict of Interest and Confidentiality statements and required DSMB materials Ad-Hoc

• Work products and documents related to tracking documents showing status of stages of compliance - Ad-Hoc

• Work products and documents related to lists of coded adverse events - Ad-Hoc

• Work products and documents related to draft emails and memos and minutes of DSMB meetings and BSR communications. - Ad-Hoc

Statement of Work Details:

• 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 Trial CT, 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 on responses - 4
• Review and Identify suitable applications for award to be classified as Clinical TrialCT, working to ensure all approved applications are correctly specified - 5

• Supports clinical staff develop, implement and maintain clinical research data files and materials.

• 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

• 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: 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

• 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 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

• Contractor shall 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

• 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 Clinical Practice and Adverse Event training

• Contractor shall 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

• 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 BSR property

• 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 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.

• 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

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

• Contractor shall 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

• Collects research data and prepares information for inputs and analysis.

• 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

• 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 Supports the development of forms and questionnaires.

• Track compliance with NIH NIA 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, DSMPDSMB materials, dissemination plan, compliance with single IRB policy, protocol

• 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 Supports 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 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

• Create and communicate plans and templates for processes, which will remain BSR property Monitors subject's progress and reports adverse events.

• 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 Supports assembly, development and review of new research projects.

• 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 clinicaltrials.gov ID number

• After an application is awarded by NIA: On a weekly basis, provide the list of coded adverse events to the PO and CTC

• Contractor shall 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

• 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 Supports the creation and management of clinical websites and web-based tools.

• Identify applications that meet the NIA criteria requiring a Data and Safety Monitoring Board DSMB

• Organizes and performs clinical research, utilizing internet and other available clinical resources.

• Assist PI to register applications identified by NIA staff as approved for award in clinicaltrials .gov

• Contractor shall 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 Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.

• 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: 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 a 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

• 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 Supports clinical staff develop, implement and maintain clinical research data files and materials.

• 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

• 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

• 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

• 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 Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.

• 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