Study Coordinator Jobs

About Us

DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. Our experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike by leveraging advanced tools – including digital transformation, artificial intelligence, data analytics, cloud enablement, modeling, and simulation, and more. With over 3,200 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to innovation to improve the lives of millions.

Overview

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 four years of experience in clinical research with a strong preference of two years’ experience in the role of a clinical study coordinator working on FDA/IND trials in an academic environment. 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. This position is an excellent opportunity for an early-stage clinical research professional to plug into the NIH system and develop one’s career. We will consider candidates with less work experience or varied work experiences on a case-by-case basis. DLH is highly interested in finding a candidate for this role who has a positive attitude, is motivated to learn and grow in the field of research, goal-oriented, empathetic, and self-aware.

Responsibilities

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 Functions

• Provide other support to cover various study needs as directed
• Draft and finalize IRB submissions and stipulations including initial and annual reviews, amendments; assembly and mailing of regulatory packages to the FDA
• Provide progress and technical reports on a regular basis, and as requested
• Timely preparation and submission of adverse event and problem reports
• Liaise with internal and external study team members and collaborators and Study Sponsor(s)
• Coordinate and assist with sample delivery and pick-up as needed
• Draft changes to protocol and protocol related study materials as needed
• Train study members
• Implement study activities in accordance with NIH and FDA regulations
• Create, prepare, and review study forms and complete quality control checks per FDA and NIH guidelines
• Report to campus at scheduled and ad-hoc times to assist with patient enrollment and study-related needs
• Work with Data Managers and Data Team members for forms preparation, and completion of adjudication procedures
• Coordinate, attend, and, on occasion, lead study-related meetings
• Develop and maintain study manuals and tracking sheets
• Complete patient enrollment activities including recruitment, screening, scheduling, follow-up and payment processing

#IND123

Qualifications

Skills Required

• Experience with drafting regulatory documents under supervision of the Principal Investigators in order to submit to the NIH Institutional Review Board (IRB) and monitoring the approval process
• Ability to verbally and in writing, effectively communicate workflow and procedures to Principal Investigators, Staff Scientists, and other Federal employees
• Aptitude for and interest in clinical and public health research
• Work independently with minimal supervision

Desired Skills And Experience

• Experience working in an academic or NIH research environment preferred
• Experience with adverse event reporting per clinical standards and FDA requirements strongly preferred
• Knowledge of medical terminology preferred
• Familiarity with NIH and/or FDA regulations for conducting human subject’s research strongly preferred, through certification (CCRP, CCRA, or equivalent), prior experience, or both

Education Or Equivalent Experience

• Bachelor's degree req'd with 2 years experience in public health, clinical research or related field.
• 2 or more years supporting clinical trials or clinical research in an applied setting that fosters development of the skills described above

Basic Compensation: $70,000-$80,000 yearly salary.

The 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.

Benefits

DLH Corp offers our employees an excellent benefits package including - Personal Time Off (PTO), medical, dental, vision, supplemental life with AD&D, short and long-term disability, flexible spending accounts, parental leave, legal services and more. We want our employees to save for their future, therefore we offer a 401(k) Retirement Plan, which includes a matching component. DLH is dedicated to your career development, providing training to help drive success, with access to our best-in-class e-Learning suite for formal and informal learning, professional and technical certification preparation, and education assistance at accredited institutions.

EEO

DLH Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.