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Clinical Study Coordinator (Job 849)

Durham, North Carolina

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 Clinical Study Coordinator to serve on a multi-disciplinary team that supports research studies associated with the National Institute of Environmental Health Science (NIEHS) Clinical Research Unit (CRU). The CRU conducts a diverse array of research studies, including pulmonary diseases, medical genetics and reproductive health, as well as investigator-initiated IND/FDA regulated studies.

The Study Coordinator will manage study activities that include, but are not limited to, planning initiation of new protocols, assisting with protocol and document development, regulatory submissions, coordinating and performing responsibilities related to research participants, overseeing compliance to protocol and regulatory requirements, and developing and adhering to relevant Standard Operating Procedures (SOPs).

This position is based on-site at the NIEHS CRU in Research Triangle Park, NC.

Responsibilities

  • Collaborate with multidisciplinary teams to support clinical research protocol implementation, data collection and human subject protection.
  • Coordinate the day-to-day study activities including recruitment, eligibility screening, scheduling, consenting, data collection, sample collection, lab processing/transfer or shipment, and problem resolution.
  • Plan and coordinate the initiation of new protocols, including assisting with the development of protocol and consents, training materials, study specific SOPs and kick-off meetings. 
  • Serve as a primary study team contact and facilitate regular study communications and meetings with the team.
  • Track study milestones, enrollment progress, and ensure completion occurs on target.
  • Prepare and submit regulatory packages to the Institutional Review Board (IRB); maintain regulatory documents and compliance with regulations and protocols.
  • Follow local laws and regulations, NIH guidelines, SOPs and specific protocol procedures. Ensure study protocols and regulatory requirements for assigned studies are being followed.
  • Assist with data collection, electronic data entry and audit checks.
  • Prepare ad hoc, progress and technical reports.
  • Contribute to the development of new study procedures, including data collection forms, electronic databases, and checklists.
  • Work with a multidisciplinary team to develop SOPs and work processes to ensure the provision of the highest quality services.
  • Support the development of procedures by facilitating discussions and tracking progress between investigator(s), and study team.
  • Provide other support to cover various study needs as directed.

Qualifications

Skills Required

  • Ability to plan, prioritize, and organize workflow and procedures
  • Strong attention to details and documentation practices
  • Ability to effectively communicate verbally and in writing
  • Ability to write clearly and concisely for regulatory reporting and submissions
  • Ability to multi-task and manage time effectively
  • Proactive and self-directed, with an ability to take direction as needed
  • Ability to pivot to meet changing requirements as needed
  • Passion and dedication to research

Desired Skills and Experience

  • Experience drafting regulatory submissions for IRB
  • Experience with protocol development and consent writing
  • Experience working at a clinical research site and/or conducting federal clinical research
  • Familiarity with investigator-initiated IND trials and FDA regulations
  • Strong proficiency with MS Word, Outlook, and Excel; full MS Office experience preferred

Education or Equivalent Experience

  • Bachelor’s degree or equivalent combination of training and experience in public health, clinical research or related field.
  • BS or equivalent + 5 yrs related experience, or MS + 3 yrs related experience.
  • Minimum of 2 years of experience as a study coordinator in a clinical research facility or comparable organization.

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.

 

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EEO

DLH Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment.  DLH will provide reasonable accommodation to individuals with disabilities and disabled Veterans who need assistance to apply.

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