Study Coordinator
Company: DLH
Location: Bethesda
Posted on: May 27, 2023
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Job Description:
SSS, a DLH Corporation company,serves federal government clients
throughout the United States and abroad delivering technology
enabled solutions in key health and human services programs. The
Company's core competencies include secure data analytics and
statistics, clinical trials and laboratory services, a full suite
of public health research offerings, performance evaluation, system
modernization, operational logistics and readiness, and strategic
digital communications. DLH has over 2,000 employees serving
numerous government agencies. DLH's portfolio consists of Defense &
Veteran Health Solutions, Human Services Solutions and Public
Health & Life Sciences.We are currently seeking a Study Coordinator
to serve on a multi-disciplinary team that conducts, analyzes, and
reports on findings from epidemiological and clinical studies on
behalf of the federal government. The studies that we conduct focus
on autoimmune diseases and environmental exposures. The ideal
candidate will have a minimum of five year of experience in
clinical research with preference of two years' experience either
monitoring and/or in the role of a clinical study coordinator
working on FDA/IND trials. The candidate should also be a
motivated, detail-oriented individual with excellent communication
and organizational skills.The full-time position will be based
onsite in Bethesda, MD at the NIH Clinical Center with tasks
assigned by the Project Manager, Study Investigators, and other
staff.Manage study activities that include, but are not limited to,
patient enrollment and scheduling, regulatory submissions,
providing laboratory support, timely preparation of adverse event
reports, assisting with general study administrative
responsibilities, coordinating and performing responsibilities
related to research participants, overseeing compliance to protocol
and regulatory requirements, and developing and adhering to
relevant SOPs. Essential FunctionsImplement study activities in
accordance with NIH and FDA regulationsComplete patient enrollment
activities including recruitment, screening, scheduling, follow-up
and payment processingDraft and finalize IRB submissions and
stipulations including initial and annual reviews, amendments;
assembly and mailing of regulatory packages to the FDACreate,
prepare, and review study forms and complete quality control checks
per FDA and NIH guidelinesWork with Data Managers and Data Team
members for forms preparation, and completion of adjudication
proceduresDraft changes to protocol and protocol related study
materials as neededLiaise with internal and external study team
members and collaborators and Study Sponsor(s)Develop and maintain
study manuals and tracking sheetsTimely preparation and submission
of adverse event and problem reportsCoordinate and assist with
sample delivery and pick-up as neededProvide progress and technical
reports on a regular basis, and as requestedProvide other support
to cover various study needs as directedCoordinate, attend, and, on
occasion, lead study-related meetings Train study membersReport to
campus at scheduled and ad-hoc times to assist with patient
enrollment and study-related needsSkills RequiredAbility to plan,
prioritize and organize workflow and proceduresAbility to enter and
audit data into web/PC-based software using Windows based
applicationsExcellent communication skillsAbility to multi-task and
manage time effectively with minimal supervisionAbility to write
clearly and concisely for regulatory reporting and submissionsWork
independently with minimal supervisionDesired Skills and
ExperienceFamiliarity with NIH and/or FDA regulations for
conducting human subject's researchExperience with patient
interaction, phone screening and schedulingAdverse event reporting
per clinical standards and FDA requirementsStrong proficiency with
MS Word, Outlook, and Excel; full MS Office experience
preferredExperience working in a research environment Knowledge of
medical terminologyEducation or Equivalent Experience Master's
degree or equivalent combination of training and experience in
public health, clinical research, nursing, epidemiology, or related
field5 or more years supporting clinical trials or clinical
research in an applied setting that fosters development of the
skills described aboveBasic Compensation: $70,000- $80,000
yearlyThe salary offered within this range will be based on the
selected candidates' skills, experience, education, market data,
and internal parity. DLH may offer other rewards that may include
performance incentives and program-specific awards. An applicant's
salary history will not be used to determine compensation.DLH is
committed to fostering a diverse workforce and is proud to be an
Equal Opportunity Employer. All qualified applicants will be
considered without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, disability or
protected veteran status.#LI-POST
Keywords: DLH, Bethesda , Study Coordinator, Other , Bethesda, Maryland
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