Clinical Research Coordinator I - Endocrinology and Diabetes

Children's Hospital of Philadelphia•Philadelphia, PA

4d•$53,000 - $66,300

About The Position

The Division of Diabetes and Endocrinology at Children’s Hospital of Philadelphia is seeking a Clinical Research Coordinator I to support research addressing diabetes in children. Working with Dr. Lorraine Katz and an experienced investigative team, the coordinator will play a key role in the DISCOVERY Study, a national initiative focused on identifying and following children at elevated risk for type 2 diabetes. The role includes participant screening, enrollment, informed consent, and study visit coordination, with exposure to other diabetes research, including studies on early identification and prevention of type 1 diabetes. The coordinator carries out protocol-related clinical research activities in accordance with IRB-approved protocols, good clinical practice, regulatory requirements, institutional policies, and applicable federal, state, and sponsor policies. The role also supports participant safety, regulatory documentation and submissions, data collection, study-team coordination, sample handling, and study closeout activities.

Requirements

At least two years of clinical or research-related experience.
Basic knowledge of IRB processes and human subject protection.
Strong verbal and written communication skills.
Strong time-management skills.
Ability to collaborate with stakeholders at all levels.
High school diploma or GED.

Nice To Haves

Bachelor’s degree.
At least three years of clinical or research-related experience.

Responsibilities

Adhere to IRB-approved protocols.
Participate in the informed consent process for study subjects.
Support the safety of clinical research patients and research participants.
Coordinate protocol-related research procedures, study visits, and follow-up care.
Screen, recruit, and enroll patients and research participants.
Maintain study source documents.
Report adverse events under the supervision of the Principal Investigator.
Understand and follow good clinical practice and regulatory compliance requirements.
Educate subjects and families about the protocol and study interventions.
Comply with institutional policies, standard operating procedures, guidelines, HIPAA, and requirements for managing confidential materials.
Comply with federal, state, and sponsor policies.
Support communication and meeting scheduling across teams for multi-site studies or collaborations.
Manage essential regulatory documents.
Register studies on ClinicalTrials.gov as appropriate.
Complete paper and electronic case report forms and address queries.
Submit documents to regulatory authorities and review or monitoring boards, as applicable.
Facilitate pre-study, site qualification, study initiation, and monitoring visits as appropriate.
Facilitate study closeout activities as appropriate.
Coordinate research and project team meetings.
Collect, process, and ship samples as applicable to the protocol.
Schedule subject visits and procedures.
Retain records and archive documents after study closeout.