Location: LOC_MAIN-Main Hospital
Req ID: 98854
Employment Status: Regular – Full Time
Functions independently in a clinical research setting and responsible for the complete coordination of a multi-site clinical trial. Partners with the Principal Investigators to develop and implement strategies to efficiently complete study. Capable of assisting with all clinical research coordinator responsibilities as detailed in the CRC job responsibilities but primary role is focused more on managing the execution of a trial across multiple sites.
Orients and trains staff handling research administration activities associated with the trial, including developing and administering training materials, standard operating procedures, and manual of study operations. Monitors service levels and identifies adequate coverage for trial and study workload across multiple studies.
- Supervise the implementation of and adherence to study protocols. Educate research and clinical staff on established policies, processes, and procedures.
- Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Develop consent forms for approval by Human Subjects Panel.
- Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.
- Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
- Monitor Institutional Review Board submissions, and respond to requests and questions.
- Provide leadership and expertise in identifying and completing research grants.
- Oversee financial resources, create internal and external budgets for research protocols, assure financial accountability, and serves as primary liaison between sponsor, department accounting, and Research.
- Provide guidance and support for clinical research coordinators who are assigned to project specific protocols and who will help with the overall clinical research of the study team.
- May have minimal supervisory responsibilities.
- Lead or chair committees or task forces to address and resolve significant issues.
- Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
- Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
- Assist with analysis of data and preparation of manuscripts and scientific presentations.
Job Responsibilities (Continued)
Job Responsibilities (Continued)
Required Licenses, Certifications, Registrations
Required Education and Experience
Required Education: Bachelor’s degree
Required Experience: Three (3) years relevant clinical research experience
Preferred Education, Experience & Cert/Lic
Preferred Education: Master’s degree
Additional Technical Requirements
- Responsible for overall management of the trial(s) to ensure compliance with study protocol, FDA, NIH and IRB policies.
- Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials.
All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.
Children’s Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children’s Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products.
Children’s Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.
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