Senior Clinical Research Coordinator - DDBP, Froehlich Lab
About The Position
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.
Requirements
- Bachelor's degree in a related field
- 7 years of experience in related job discipline OR Master's degree and 6 years experience
- Cert Clinical Research Coord within 18 months of external hire
- 7+ years of clinical research experience
- Strong supervisory or management skills
- Experience leading complex research projects
- Clinical trial experience
- Expertise in REDCap
- Expertise in regulatory processes
- Expertise in Good Clinical Practice (GCP) standards
- Experience working with individuals with intellectual and developmental disabilities
Responsibilities
- 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.
- 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 those regulations.
- Ensure the documentation of regulatory activities in appropriate systems.
- Coordinate and maintain up-to-date and accurate written and electronic records and files.
- Prepare study staff for recruitment/enrollment for medium to large/complex complexity projects.
- Oversee study staff performance.
- Proactively take initiative to ensure recruitment stays on track with the project time-lines.
- Implement successful plan to identify potential participants.
- Engage study staff to assist in identifying and enrolling participants.
- Proactively identify and monitor barriers to recruitment and problem-solve or innovate to overcome them.
- Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly.
- Create and maintain a detailed tracking system for participants considered for enrollment.
- Track progress at regular intervals and report out to PI and or management.
- Oversee data entry and validation to ensure accuracy, quality and compliance of data collection process.
- Create case report forms (CRFs) in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry.
- Create Data Dictionary, as per protocol and in conjunction with principal investigator and statistician.
- Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors.
- Maintain and audit data, providing status and activity reports as required.
- Organize data to analyze, identify, and report trends.
- Review reports, tables, and listings.
- Assist in data analysis and maintain record keeping and data storage for clinical research studies.
- Maintain master database files for clinical research protocols.
- Prepare reports from validation studies of clinical research projects.
- Evaluate and resolve issues regarding contents of reports.
- Ensure quality of data submitted from study sites and assure timely submission of data.
- Oversee the processing of laboratory and other external data.
- Serve as a regularly participating reviewer in the advancement process as established by the advancement ladder materials.
Benefits
- Additional pay (e.g., shift, on‑call, or weekend differentials) and benefits may apply.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
