Senior Clinical Research Coordinator - DDBP, Froehlich Lab

• Expected Starting Pay Range $74,297.60 - $94,744.00
• Starting pay is based on experience, skills, and equity; exceptions may apply for highly qualified candidates. Additional pay (e.g., shift, on‑call, or weekend differentials) and benefits may apply. Annual pay may vary based on FTE status.

Primary Location
MOB - 3430 Burnet

Department
DDBP

Shift
Day (United States of America)

Schedule
Full time

Weekly Hours
40

FTE
1

Employee Status
Regular

• Expected Starting Pay Range $74,297.60 - $94,744.00
• Starting pay is based on experience, skills, and equity; exceptions may apply for highly qualified candidates. Additional pay (e.g., shift, on‑call, or weekend differentials) and benefits may apply. Annual pay may vary based on FTE status.

The Froehlich Lab in the Division of Developmental and Behavioral Pediatrics conducts clinical research focused on improving outcomes for children with ADHD and other developmental-behavioral conditions, including those with complex medical, developmental, and psychosocial needs.

The Senior Clinical Research Coordinator will provide leadership for clinical research studies, overseeing study operations, regulatory compliance, participant engagement, data management, and study execution. This role will also serve as a key resource for the research team by providing supervision, training, mentorship, and day-to-day guidance to junior clinical research coordinators. The ideal candidate will bring 7+ years of clinical research experience, strong supervisory or management skills, and experience leading complex research projects.

Clinical trial experience is highly desirable, along with expertise in REDCap, regulatory processes, and Good Clinical Practice (GCP) standards. Experience working with individuals with intellectual and developmental disabilities is also highly valued. The successful candidate will thrive in a collaborative environment dedicated to advancing research that improves the lives of children and families.

• Study Conduct/ Clinical Research Practice
  - Serve as a resource for others for all aspects of conducting a clinical trial for complex and multi-center trials. Develop & implement associated projects related to studies under the guidance of the principal investigator. Collaborate effectively with others to ensure proper progress & completion of studies. Assist other members by educating, providing resources, & consulting on difficult protocols or projects.
  
  Indirectly (or directly) supervise other CRCs. Train new staff in preparation & conduct of clinical trials. Provide oversight and guidance as needed to research staff. Collaborate on multiple projects or studies, and support other staff or the work flow involved in research work. Provide oversight and guidance to research staff for all aspects of conducting a clinical trial for complex and multi-center trials.
  
  Collect and process specimens to meet study requirements. Work with other divisions as needed to ensure proper handling, processing, storage and tracking of specimens per study requirements.
• Regulatory Compliance and Documentation
  - Coordinate complex regulatory activities & periodic internal self-audit of records. May lead staff in regulatory activities. Provide oversight for the preparation, review, submission and maintenance of regulatory activities/submissions, ensure accuracy and timeliness to all collaborative parties. Provide oversight and guidance for project procurements. Coordinate and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner.
  
  Organize the review, correspondence and approval of human research protocols with all regulatory authorities, including study closeout. Determine which research protocols or issues have additional requirements, i.e. review by additional CCHMC Divisions, regulatory agencies, or consultants, and coordinate the process to meet these requirements. Act as a resource for regulatory affairs. Apply federal regulations; state and local law; and CCHMC and division policies and standard operating procedures (SOPs) to promote ethical practices in research involving human participants and to ensure compliance to…