Social & Scientific Systems (S-3)

Study Coordinator II

US-NC-Research Triangle Park
Job ID
2017-1710
Category
Clinical
Type
Regular Full-Time

Overview

Social & Scientific Systems (SSS) works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.

 

Responsible for implementing research studies and providing study coordination for research associated with the National Institute of Environmental Health Science (NIEHS) Clinical Research Program. The Study Coordinator will be part of a team that consists of research nurses, study coordinators, a participant coordinator, a respiratory therapist, and operations manager. The study coordinator will interact regularly with the CRU team as well as NIH research scientists and academic collaborators. The position is based onsite at the NIEHS CRU in Research Triangle Park, NC where s/he will work as part of a team with both SSS and Federal employees.

Responsibilities

  1. Collaborate with multidisciplinary teams to support clinical research protocol implementation, data collection and human subject protection.
  2. Conduct and coordinate a variety of clinical research studies within the CRU, NIEHS, or at off-site research institutions where collaborative studies occur.
  3. Coordinate the day to day study activities including recruitment, obtaining consent, eligibility screening, scheduling, data collection, sample collection, lab processing/transfer or shipment, problem resolution, and regular study communications and meetings with the study team.
  4. Develop and implement recruitment plans and strategies, actively pre-screen and schedule participants, track and report on efforts and study enrollment/completion.
  5. Support the development of procedures to operationalize investigator initiated protocols by facilitating discussions and tracking progress between investigator(s), study team, and protocol writer as needed.
  6. Support coordination of response to scientific reviewers and update documents as required through pre-IRB and IRB approval.
  7. Prepare and submit regulatory packages to the Institutional Review Board (IRB) including amendments and annual reporting; maintain regulatory documents and compliance with regulation and protocols.
  8. Plan and coordinate the initiation of new protocols, including the development of training materials, study specific procedure manuals and kick-off meetings.
  9. Serve as a primary study team contact, tracks study milestones, enrollment progress and ensures completion occurs on target.
  10. Follow local laws and regulations, NIH guidelines, SOPs and specific protocol procedures. Ensure study protocols and regulatory requirement for assigned studies are being followed.
  11. Assist with data collection, electronic data entry and audit checks.
  12. Prepare ad hoc, progress and technical reports.
  13. Contribute to the development of new study procedures, including data collection forms, electronic databases, checklists, and informed consents as new studies are implemented.
  14. Work with a multidisciplinary team to develop Standard Operating Procedures (SOPs) and work processes to ensure the provision of the highest quality services.
  15. Occasional weekend work might be required.

Qualifications

A Bachelor's degree or equivalent combination of training and experience in public health, clinical research or related field. Minimum of 3-5years of experience as a study coordinator in a clinical research facility of comparable organization and a good understanding of conducting clinical research studies according to current laws and regulations, established SOPs, Good Clinical Practices (GCP) and federal guidelines. Experience working on clinical research projects from study start up through close out and ability to work collaboratively with interdisciplinary study teams. Experience at a clinical research site and/or conducting federal clinical research preferred. Experience with REDcap and/or Clinical Conductor CTMS a plus.

 

Skills

Effective communication, organization, and technical skills. Proficient in computer usage (i.e. word processing, spreadsheets, data entry, electronic mail and internet functions).

 

SSS is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.

 

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