Clinical Research Coordinator

We need to output HTML fragment with sections: only those with real content. The posting includes Position Objective, Duties And Responsibilities (long list). No explicit sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can map: Position Objective could be under "About the role" maybe. Duties And Responsibilities is responsibilities. No explicit requirements/qualifications etc. So we should include sections for which we have content: maybe "About the role" (from Position Objective) and "Responsibilities" (the duties). No Benefits, Pay, Schedule etc. So output

About the role

...objective...

then

Responsibilities

• ... each duty as list item

. Need to preserve all substantive information, not invent. Must not repeat job title. No metadata like Job ID. Remove boilerplate etc. The duties list is long; we need to break into list items for each duty. The text includes many sentences separated by numbers and semicolons. We'll parse into separate items. Ensure we keep all details. We'll produce HTML fragment. Let's extract objective: "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." We can strip "Position Objective:" and keep sentence. Now duties: The text after "Duties And Responsibilities" includes many numbered items (1,2,3,4) and then many sentences. We'll split each sentence or clause that starts with a verb. Better to create list items for each distinct duty. We'll try to capture each bullet-like statement. Given the length, we can produce many

items each containing a duty as described. We need to be careful not to lose any info. Let's manually parse: After "Duties And Responsibilities" we have: 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 1Review and Identify suitable applications for award to be classified as Clinical TrialCT, working to ensure all approved applications are correctly specified 2Report findings of CT applications, by developing summary statements to identify Human Subjects Concerns and request any necessary corrections from the applicant via email; 3Work with Clinical Trial Coordinator CTC to advise applicants that Authorized Organizational Representative AOR concurrence is required responses 4Identify applications that meet the NIA criteria requiring a Data and Safety Monitoring Board DSMBFor 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 policiesAssist Principal Investigators PIs in revising DSMPs to be consistent with policies Advise Project officer PO of exceptions to get PO approval to move forwardTrack 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, protocolAssist PI to register applications identified by NIA staff as approved for award inclinicaltrialsgovReview 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 numberAfter 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 requiredAfter an application is awarded by NIA: Draft emails for PO approval and signature requesting additional data from investigators withAOR concurrence on safety or other issues arising during the projectAfter an application is awarded by NIA: Assist PIs, AORs and DSMBs in the coding of adverse events using the latest version of theMedical 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 queriesAfter an application is awarded by NIA: On a weekly basis, provide the list of coded adverse events to the PO and CTCFor awarded Applications, requiring a DSMB: The contractor shall provide administrative support services to PO specific to NIA appointed DSMBsFor awarded applications requiring a DSMB: Assist PO with assessments, recommendations, and general support in establishing the DSMBDepending 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 expertiseTrack receipt of DSMB signed Conflict of Interest and Confidentiality statements and required DSMB materials Recontact PI weekly until all required documentation has been receivedNotify the PO when all DSMB materials are received and complete and are ready for POs approval, subject to NIA Directors approvalPrepare emails for PO approval and signature to communicate any concerns regarding the proposed DSMB with the PI, and requestDSMB modifications as appropriate4Draft memo for PO approval and signature to the Director of NIA requesting approval of DSMBContractor will coordinate with CTC to request services such as power analysis if requested by DSMB or POCoordinate scheduling of PO availability for DSMB meetings, prepare calendar appointments, and make sure PO has all relevant materials prior to meetingsIf 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 protocolIdentify 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 policiesWork with CTC to compile a list of grants requiring a DSMB Work to obtain Clinical Research Liability Insurance coveringprofessional and general liability including punitive damages for the DSMB membersFor 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 meetingContractor shall update annual status of recruitment enrollment in NIH Human Subjects Reporting SystemIf required by PO, contractor shall track recruitment more regularly eg, some projects may require monthly trackingContractor shall review annual progress report of project If a project is on a quarterly reporting schedule, contractor shall closely monitor progress of such trialsContractor shall remain current on training specified by BSR, to include Good ClinicalPractice and Adverse Event trainingContractor 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 policiesContractor 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 POsCreate and communicate plans and templates for processes, which will remain BSRpropertyContractor 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 eqSharePoint 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 enrollmentWork 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 assessmentWork 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 providing lists of completed checklists used to review DSMBsWork products and documents related to track receipt of DSMB signed Conflict ofInterest and Confidentiality statements and required DSMB materialsWork products and documents related to tracking documents showing status of stages of complianceWork products and documents related to lists of coded adverse eventsWork products and documents related to draft emails and memos and minutes of DSMB meetings and BSR communications We need to split into list items. Could be many; but we can group similar items. Given the instruction: "Prefer a few substantive sections over many thin ones." So we could have one Responsibilities section with a long list (

• ... many items ...

). That's fine. We need to ensure we don't lose any substantive detail. We'll create list items for each major duty as we can infer from the text. Let's craft items: - 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 Trials (CT), ensuring all approved applications are correctly specified. - Report findings of CT applications by developing summary statements to identify human subjects concerns and request necessary corrections from applicants via email. - Work with the Clinical Trial Coordinator (CTC) to advise applicants that Authorized Organizational Representative (AOR) concurrence is required. - Identify applications that meet NIA criteria requiring a Data and Safety Monitoring Board (DSMB). For CT applications requiring a DSMB, work with CTC to inform applicants 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 (including Data and Safety Monitoring Plan (DSMP) and information on DSMB membership and contact information). - For applications identified by NIA staff as approved for award, take actions prior to award including but not limited to: * Work with CTC to review DSMP using the NIA-provided DSMP checklist, 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 the Project Officer (PO) of exceptions to obtain PO approval to move forward. * Track compliance with NIH/NIA policies for approved applications, including whether a risk assessment has been completed, final documentation received, and outstanding items (e.g., DSMP/DSMB materials, dissemination plan, compliance with single IRB policy, protocol). * Assist PIs to register approved applications on ClinicalTrials.gov. * Review the 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: * Collaborate with CTC to ensure review of regular data reports, including unmasked data needed on adverse events; document and advise PO of response resolution (PO review required). * Draft emails for PO approval and signature requesting additional data from investigators, with AOR concurrence on safety or other issues arising during the project. * Assist PIs, AORs, and DSMBs in the coding of adverse events using the latest version of the Medical Dictionary for Regulatory Affairs (MedDRA); communicate with PI to collect adverse events reported since the last reporting period or study start and resolve any