Clinical Research Coordinator I - The Center for Precision Medicine for | Philadelphia, PA

Detailed Information

  • Location: Philadelphia, PA

  • Company: Children's Hospital Of Philadelphia

and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career. CHOP's Commitment to Diversity, Equity, and Inclusion CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace.

We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children. We strongly encourage all candidates of diverse backgrounds and lived

experiences to apply. A Brief Overview Under moderate supervision from study PI or other research study management staff, this role provides substantial coordination level support for all clinical research activities within the scope of clinical research protocols.

The Center for Precision Medicine for High-Risk Pediatric Cancer is focused on developing molecularly targeted anti-cancer therapies for pediatric patients with cancer, with the goal of expanding therapeutic options and improving the quality of life for our patients. This program is looking for a Clinical Research Coordinator I to assist with the coordination of various biospecimen collection protocols and early phase clinical

trials. The goal of these clinical trials is to evaluate both the safety and efficacy of novel anti-cancer drug therapies, as well as develop a bank of biospecimens to be used to advance clinical testing.

The program offers a diverse portfolio of trial options to patients; there are typically 20 or more clinical trials open to accrual. The Precision Medicine team is a member of various national consortia for drug development in childhood cancer, including the Children's Oncology Group (COG) Phase 1/Pilot Consortium. In addition to conducting COG studies, the team also conducts industry-sponsored and investigator-initiated clinical trials of new agents. Under moderate supervision, coordinates all clinical research activities within the scope of clinical research protocols.

What you will do 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 Under the supervision of PI 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, and with HIPAA and management of confidential materials Must comply with federal, state, and sponsor policies For multi-site studies or collaborations, support communication and meeting scheduling across teams Related responsibilities Manage essential regulatory documents Register study on Clinical Trials. gov as appropriate 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 as appropriate Facilitate study close out activities as appropriate Coordinate research/project team meetings Collect, process and ship samples as applicable to the protocol Schedule subject visits and procedures Retain records/archive documents after study close out Education Qualifications High School Diploma / GED Required Bachelor's Degree Preferred Experience Qualifications At least two (2) years of clinical or clinical related or research related experience.

Required At least three (3) years of clinical or clinical related or research related experience. Preferred Skills and Abilities Basic knowledge of IRB and human subject protection. (Required proficiency) Strong verbal and written communications skills (Required proficiency) Strong time management skills (Required proficiency) Ability to collaborate with stakeholders at all levels (Required proficiency) To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community.

As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more. Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed. EEO / VEVRAA Federal Contractor Tobacco Statement

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