Employment Status: AF - Active - Regular - Full Time
The research coordinator position will contribute to the CHOP Mitochondrial Medicine team by supporting and leading a new phase 2/3 drug trial.
The ideal candidate will
* Conduct clinical research in full accordance of federal and institutional regulations and procedures (e.g., FDA, ICH, GCP)
* Under minimal supervision, complete daily core functions of assignments and protocols; achieve long-term study milestones and recruitment goals
* Ability to effectively execute and manage investigational drug protocols, while emphasizing patient safety and regulatory compliance
* Collaborate with sponsors and investigators for protocol development, study recruitment, informed consent procedures, data collection and analysis, safety reporting, IRB, FDA, and regulatory processes
Our ideal candidate should have
* Extensive knowledge and practice (at least 2 years) of human subjects research and regulatory affairs
* A relevant bachelor's degree and/or strong experience within the biomedical field
* Professional experience in hospital settings and clinical laboratories
* Ability to effectively communicate and interact with patients and families
* Responsible for the coordination of clinical research activities conducted within the CHOP healthcare network.
* Responsible for multiple projects and must possess full knowledge and understanding of all assigned protocols.
* Works with minimal supervision by a senior CRC or a clinical research team manager and within the scope of clinical research protocols, participates in research activities which may include: subject recruitment, confirmation of subject eligibility, informed consent process, completion of case report forms, data clarification, IRB preparations, chart abstraction, hosting monitor visits, organizing site initiation visits.
* Expected to meet enrollment projections within study-specified times.
* Hosts in-services on floors independently.
* Will be encouraged to attend appropriate local educational sessions each year.
* Must be knowledgeable on and have full understanding of good clinical practices (GCP) and regulatory responsibilities and will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources.
Required Education and Experience
Required Education:: BA/BS in a related field
Required Experience: 3+ year(s) relevant clinical research coordination experience
Preferred Education, Experience & Cert/Lic
Preferred Education: MA/MS in a related field
Preferred Experience: 1+ year(s) relevant clinical research coordination experience
Additional Technical Requirements
Requires effective writing and communication, work as part of a team, ability to multitask
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 or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).
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.
VEVRAA Federal Contractor/Seeking priority referrals for protected veterans. Please contact our hiring official with any referrals or questions.
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