Supervisor, Clinical Research Coordinator, Neonatology
About The Position
The Clinical Research Coordinator Supervisor (CRC-Su) independently coordinates multiple assigned human-subjects clinical research projects and performs all core Clinical Research Coordinator responsibilities. The Supervisor provides mentorship, education, leadership, and first-line supervisory oversight, including involvement in hiring, performance review, and termination of associates. Study management includes assessing protocol feasibility; preparing materials for regulatory review and Institutional Review Board submissions; identifying potential participants; coordinating and collecting research data and specimens; maintaining accurate and timely study records; participating in quality-assurance audits; managing study materials and supplies; communicating across teams; and archiving records according to applicable policies and procedures. The Supervisor also manages financial components of projects, documents investigator products (drugs or devices), develops source documents and/or case report forms, and runs research or project team meetings. The role may support investigator-initiated Investigational New Drug or Investigational Device Exemption applications, monitor or audit Research Institute studies, mentor and educate clinical staff and research personnel, and coordinate multi-center studies. The Supervisor evaluates CRC performance and assists the Site Manager with workload, protocol implementation, and data-collection issues. The position may also participate in Research Institute workgroups or committees focused on CRC operations. This is the most senior position in the Clinical Research Coordinator series.
Requirements
- At least six years of clinical research coordination experience.
- Bachelor’s degree, or equivalent additional experience in lieu of education.
- Working knowledge of Microsoft Office programs, including Word, Excel, and PowerPoint.
- Strong interpersonal skills and effective oral and written communication.
- Attention to detail and ability to work under pressure in a fast-paced environment while managing competing priorities.
- Working knowledge of human-subjects regulatory requirements and ICH-GCP guidelines.
- Ability to conduct informed consent.
- Strong knowledge of research sample identification, processing, and storage.
- Ability to manage conflict and create a culture of accountability within the assigned team.
- Good time and priority management and problem-solving ability.
- Basic Life Support (BLS) certification from the American Heart Association; if not held at hire or promotion, certification is expected within six months, subject to possible management-approved extension for extenuating circumstances.
- ACRP-CP, CCRP, or CCRC certification; if not held at hire or promotion, certification is expected within 12 months, subject to possible management-approved extension for extenuating circumstances.
- Able to meet the listed physical activity and functional demands, including lifting and carrying 25–35 pounds and pushing or pulling 50–100 pounds.
Nice To Haves
- Clinical research experience in a hospital setting and/or pediatric clinical research experience.
- Demonstrated leadership experience.
- Master’s degree in a relevant field.
- Working knowledge of Cerner or an equivalent electronic medical record system.
- Phlebotomy certification.
Responsibilities
- Coordinate multiple assigned human-subjects clinical research projects independently and perform core Clinical Research Coordinator responsibilities.
- Provide mentorship, education, and leadership, with first-line supervisory oversight that may include hiring, reviewing, and terminating associates.
- Assess feasibility of clinical research protocols.
- Prepare materials for regulatory review and Institutional Review Board submissions.
- Identify potential study participants.
- Coordinate and collect research data and specimens.
- Complete study records accurately and on time; archive records in accordance with applicable policies and procedures.
- Participate in quality-assurance audits and manage study materials and supplies.
- Communicate across multiple teams.
- Manage financial components of clinical research projects.
- Document investigator products, including drugs or devices, and develop source documents and/or case report forms.
- Run research and project team meetings.
- Support investigator-initiated Investigational New Drug or Investigational Device Exemption applications as needed.
- Monitor or audit Research Institute studies as needed.
- Educate and mentor clinical staff, research team members, and other coordinators.
- Coordinate multi-center studies as requested.
- Evaluate Clinical Research Coordinator performance.
- Assist the Site Manager in resolving operations workload, protocol implementation, and data-collection issues.
- Participate in Research Institute workgroups or committees focused on CRC operations.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
