Clinical Research Coordinator - Neonatology

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Clinical Research Coordinator V

Seeking Breakthrough Makers

Children'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 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
This role functions independentlyin a clinical research setting and is responsible for the complete coordination of complex clinical research activities within the scope of clinical research protocols.

May supervise/lead one or more study team members.

What you will do

• Applies in depth knowledge of clinical research and independently coordinates the activities of multiple large-scale, complex multi-center / multi-institutional studies
• In partnership with other business units, prepares, negotiates and manages study budgets and finances with the PI
• Coordinates and participates in the process of contract negotiation and finalization and is well-versed in contract language and study team responsibilities
• Accountable for study oversight and monitoring activities at multiple sites/institutions
• Prepares study sites for internal/external regulatory audits (sponsor, FDA, NIH, etc)
• Supervises and trains new staff, contributes and completes staff annual performance reviews as appropriate
• Leads research/projectteams
• 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 high level recommendations
• May support multiple PI sponsored INDs or IDEs
• Serves on clinical research committees/activities within division or institution.
• Screens, recruits 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 policies

Education Qualifications

• Bachelor's Degree Required
• Master's Degree in a related field Preferred

Experience Qualifications

• At least seven (7) years relevant research experience Required
• At least nine (9) years of clinical/research coordination experience Preferred

Skills and Abilities

• Intermediate knowledge of IRB and human subject protection (Required proficiency)
• Advanced proficiency in data management systems/tools (Required proficiency)
• Basic knowledge of Clinicaltrials.gov (Required proficiency)
• Excellent verbal and written communications skills (Required proficiency)
• Excellent time management skills (Required proficiency)
• Excellent analytical 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.

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