Clin Research Coordinator I - Clinical Research Support Office: Staffing Core
Philadelphia, PA, US, 19104
LOC_COLKET-Colket Translational Research Req ID: 34041
Shift: Days
Employment Status: Regular - Full Time
This is a full time position within the Clinical Research Support Office Staffing Core. The CRSO Staffing Core is a central staffing office that provides research staff to investigators throughout the CHOP Research Institute. The coordinators within the RSC are assigned to assist investigators with many types of clinical research studies, such as PI-initiated, behavioral health, data abstraction, interview/survey based, registry, and all phases of intervention, drug, and device trials.
Under moderate supervision, coordinates all clinical research activities within the scope of clinical research protocols.
Core responsibilities
- Adhere to an IRB approved protocol
- Participate in the informed consent process of study subjects
- Support the safety of clinical research patients/research participants
- Coordinate protocol related research procedures, study visits, and follow-up care
- Screen, recruit and enroll patients/research participants
- Maintain study source documents
- Report adverse events
- Understand good clinical practice (GCP) and regulatory compliance
- Educate subjects and family on protocol, study intervention, etc.
- Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
- Must comply with federal, state, and sponsor policies
Related responsibilities
- Manage essential regulatory documents
- Register study on ClinicalTrial.gov
- Complete case report forms (paper & electronic data capture) and address queries
- Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
- Facilitate pre-study, site qualification, study initiation, and monitoring visit
- Facilitate study close out activities
- Coordinate research/project team meetings
- Collect, process and ship laboratory specimens
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
Required Education: Associates Degree or active enrollment in a Bachelor’s Degree Program
Required Experience: Three (3) years of relevant clinical research experience.
Preferred Education: Bachelor’s Degree in related field
- Excellent verbal and written communications skills
- Excellent time management skills
- Ability to collaborate with stakeholders at all levels
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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Job Segment:
Clinic, Medical, Medical Research, Clinical Research, Healthcare, Research
