Clinical Research Coordinator III - Gene Therapy
Reference #: 1010503
SHIFT:Day (United States of America)Seeking Breakthrough MakersChildren's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.At CHOP, your experience is valued; your voice is heard; 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 InclusionCHOP 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
This role functions independentlyin a clinical research setting and is responsible for the complete coordination of assigned clinical research activities within the scope of clinical research protocols. May have supervisory responsibilities of study team staff.What you will do
Applies in depth knowledge of clinical research and independently coordinates the activities of 1 or more large-scale, complex multi-center / multi-institutional studies
Provides oversight in the preparation, management and monitoring of study budgets
Accountable for study oversight at one or more sites/institutions
May be responsible for conducting monitoring activities at one or more sites/institutions
Prepares study sites for internal/external regulatory audits (sponsor, FDA, NIH, etc)
Facilitates and/or leads research/projectteammeetings
Educates and mentors internal and external clinical staff, research teams and other coordinators; provides resources, and consulting on difficult protocols or projects
Independent of the PI assesses and critiques protocol feasibility and provides recommendations
May support 1 or more PI sponsored INDs or IDEs
Liaises between Research billing (CTFM) and the research team
Participate in the informed consent process of study subjects
Scheduling, facilitating and/or leading research/project team meetings
Screen, recruit and enroll patients/research participants
Report adverse events
Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
Must comply with federal, state, and sponsor policiesEducation Qualifications
Bachelor's Degree Required
Master's Degree in a related field PreferredExperience Qualifications
At least four (4) years of clinical/research coordination experience Required
At least five (5) years of clinical/research coordination experience PreferredSkills and Abilities
Intermediate knowledge of IRB and human subject protection
Basic proficiency in data management systems/tools
Excellent verbal and written communications skills
Excellent time management skills
Solid analytical skills
Ability to collaborate with stakeholders at all levelsTo 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 StatementChildren'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.