Clinical Research Coordinator - NIH - Bethesda, MD

Company: Kelly Services
Location: Bethesda
Posted on: September 13, 2020

Job Description:

Clinical Research Coordinator - NIH - Bethesda, MD Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Operations Coordinator with the National Institutes of Health in Bethesda, MD.

This is a long-term contract position which offers:

- Competitive salary with comprehensive benefit package

- Opportunity to work at NIH, the world's foremost medical research center

- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com at http://www.kellygovernmentsolutions.com/

**TASKS.** The contractor shall:

+ 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.

+ 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 PO of exceptions to get PO approval to move forward.

+ 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 (e.g., DSMP/DSMB 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 clinicaltrials.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: Assist PIs, AORs and DSMBs in the coding of adverse events using the latest version of the Medical Dictionary for Regulatory Affairs. ( _I.e.,_ 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 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.

+ Manage scheduling of PO availability for DSMB meetings, prepare calendar appointments, and make sure PO has all relevant materials prior to meetings.

+ As requested 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 directed 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 Standard Operating Procedure documents for all tasks related to BSR handling of clinical trials on the BSR (e.q. 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

+ Clinicaltrials.gov Identifier number

+ Proposed and actual recruitment/enrollment.

**REQUIREMENTS.** The contractor must have:

+ Masters degree in a related discipline; three (3) to 5 years of experience in clinical research or a related field.

+ Three (3) years of specialized experience plus a BA/BS degree in Biological, Behavioral, or healthcare sciences is equivalent to a Masters Degree.

+ Three years of experience in Clinical research or a related field. Demonstrates strong experience with data collection.

+ Demonstrates superior knowledge of research protocols and clinical, scientific and/or medical terminology.

+ Expertise in Microsoft Office Suite (MS Word, Excel, PowerPoint, Excel, Access) and WordPerfect.

+ Strong communications skills, both oral and written.

+ Excellent interpersonal, analytical, organizational and time management skills.

+ Experience working in clinical trials.

+ Minimum 2 to 4 years experience working with human subjects research protocols.

+ Knowledge of federal and local regulations and policies pertinent to research involving human subjects.

+ Current certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) preferred. Certified Clinical Research Associates (CCRA) may also apply.

PLEASE APPLY ONLINE.

Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.

**Why Kelly** **** **?**

Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.

**About Kelly** ****

Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. Were always thinking about whats next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law.

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Keywords: Kelly Services, Bethesda , Clinical Research Coordinator - NIH - Bethesda, MD, Other , Bethesda, Maryland