Clinical Research Coordinator - NIH - Bethesda, MD Kelly
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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
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**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
+ 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,
+ 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
+ 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
+ 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
+ For awarded applications requiring a DSMB: Assist PO with
assessments, recommendations, and general support in establishing
+ 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
+ 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
+ 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
+ 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
+ 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
+ Experience working in clinical trials.
+ Minimum 2 to 4 years experience working with human subjects
+ 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** **** **?**
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**About Kelly** ****
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