Clin Research Coordinator II-Division of Human Genetics-Mitochondrial Medicine
Philadelphia, PA, US, 19104
Job Type:
LOC_ABRAMSON-Abramson Building Req ID: 71842
Shift: Days
Employment Status: Regular - Full Time
Job Summary
The Mitochondrial Medicine program is seeking to fill multiple clinical research coordinator roles to support new phase 2/3 drug trials.
Mitochondrial Medicine at Children’s Hospital of Philadelphia (CHOP) is emerging as the premiere center in the world for multidisciplinary clinical care, advanced diagnostics and therapies, and individualized basic, translational, and clinical research programs dedicated to improving the health of patients of all ages living with mitochondrial disease. The program is part of the Division of Human Genetics.
As a Frontier Program at CHOP, the Mitochondrial Medicine program is a unique, cutting edge program that will forge important discoveries...
Preferred applicant must possess strong experience with clinical trials, human subject research safety, and with regulatory procedures with FDA and industry studies.
Under minimal supervision, complete daily core functions of IRB studies
Ability to execute and manage investigational drug protocols according to internal timelines, while emphasizing patient safety and regulatory compliance
Professional experience in hospital settings; ability to effectively communicate and interact with patients and families
Job Responsibilities
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
Also may be responsible for any of the following:
- Manage study finances including sponsor invoicing & resolving study subject billing issues
- Develop advertisement materials
- Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
- Document investigational product (drug/device) accountability
- Self-monitor and self-audit responsibilities
- Develop informed consent document
- Maintain Clinical Trial.gov
- Develop Case Report Forms
- Assignments to include more complex studies
Job Responsibilities (Continued)
Required Licenses, Certifications, Registrations
Required Education and Experience
Required Education: Bachelor’s Degree in related field
Required Experience: Three (3) years of relevant clinical research coordination experience.
Preferred Education, Experience & Cert/Lic
Preferred Education: Master’s degree in a related field
Preferred Experience: Five (5) years of relevant clinical research coordination experience
Additional Technical Requirements
- 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 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.
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CHOP Careers Contact
Talent Acquisition
2716 South Street, 6th Floor
Philadelphia, PA 19146
Phone: 866-820-9288