Social & Scientific Systems, Inc.
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Study Coordinator II
at Social & Scientific Systems, Inc.
- Job ID
- Regular Full-Time
Social & Scientific Systems (SSS) works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. Our research and support for domestic and international health programs enable policymakers, medical professionals, communities, and citizens to improve public health. Please join our dedicated staff in an environment that values diversity and supports health, wellbeing, 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 study team that consists of a lead project manager, research associates, programmers, data managers and analysts. Additionally, this position will serve as the team liaison to the NIEHS Clinical Research Unit (CRU) and the CRU team comprised of medical director(s), investigators, research nurses, study coordinators, a participant coordinator, a respiratory therapist, and operations manager. The position is based at SSS headquarters in Durham, but will spend 25-50% of their time at the NIEHS CRU in Research Triangle Park, NC.
- Collaborate with multidisciplinary teams in the planning, coordination, execution and oversight of a variety of clinical research studies within the CRU, NIEHS, or at off-site research institutions where collaborative studies occur.
- Lead the planning (including budget and timeline estimates and resource identification) and execution of study activities that may include recruitment, screening, scheduling, data and sample collection, lab processing/transfer or shipment.
- Serve as a primary study team contact at the NIEHS CRU, track project milestones including enrollment progress, compliance with budget and timeline parameters.
- Track and document study communications and meetings with the study team, CRU staff, investigators and other key contributors.
- Contribute to the development of new study procedures, including data collection forms, electronic databases, checklists, and informed consents as new studies are implemented.
- Work with a multidisciplinary team to develop and implement Standard Operating Procedures (SOPs) and work processes to ensure the provision of the highest quality services.
- Plan and coordinate the development of training agenda and materials as needed.
- 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.
- Follow Federal regulations, NIH guidelines, SOPs and specific protocol procedures. Ensure study protocols and regulatory requirement for assigned studies are being followed.
- Assist with data collection, electronic data entry and audit checks as needed.
- Engage in participant recruitment, follow up, engagement and retention efforts.
- Prepare ad hoc, progress and technical reports.
- A Bachelor's degree or equivalent combination of training and experience in public health, clinical research or related field.
- Minimum of 3-5 years 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 studies collecting survey data and biological specimens also preferred.
- Experience with protocol-development and investigator-initiated IND studies a plus.
- Strong 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.