Study Coordinator

Company: DLH
Location: Bethesda
Posted on: May 27, 2023

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