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Clinical Research Coordinator-Division of Genomic
Philadelphia, PA, US, 19104
LOC_ABRAMSON-Abramson Building Req ID: 52481
Employment Status: Regular - Full Time
Children's Hospital of Philadelphia strives to be the world leader in the advancement of healthcare for children by integrating excellent patient care, innovative research and quality professional education into all of its programs. The Hospital was one of the first in the United States to recognize the importance of treating all aspects of the patient, including emotional well-being and that of the child's family. We work to educate families as partners in their children's care, and we rely on their feedback to improve our services.
At Children's Hospital of Philadelphia, we provide an environment that's as nurturing as it is dynamic. Our team-oriented approach allows for ample learning and career growth opportunities. We think you'll find that CHOP offers the ideal atmosphere in which to best use your skills and talents. We are eager for your input, ideas and inspiration.
The Roberts Individualized Medical Genetics Center (Roberts IMGC) together with the Division of Genomic Diagnostics at CHOP is currently recruiting a full time Clinical Research Coordinator I to join the exciting and growing research program with several medical geneticists, laboratory geneticists, researchers, genetic counselors, and other personnel.
The current position will include primary responsibilities for study coordination, clinical enrollment and consenting of patients and families who undergo a whole genome sequencing test. The individual will assist with relevant study protocol information updates and will be responsible for documenting the relevant patient information as outlined by the study protocol. The individual will participate in research team meetings, broader programmatic meetings, and continued education and training within the CHOP Research Institute related to this role.
* 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
* 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
Job Responsibilities (Continued)
Required Licenses, Certifications, Registrations
Required Education and Experience
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, Experience & Cert/Lic
Preferred Education: Bachelor's Degree in related field
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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