Clinical Research Coordinator III

Children’s Hospital of Philadelphia•Philadelphia, PA

About The Position

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. A Brief Overview This role functions independently in 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/project team meetings 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 policies

Requirements

Bachelor's Degree - Required
At least four (4) years of clinical/research coordination experience - Required
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 levels

Nice To Haves

Master's Degree in a related field - Preferred
At least five (5) years of clinical/research coordination experience - Preferred

Responsibilities

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/project team meetings
Educates and mentors internal and external clinical staff, research teams and other coordinators
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 policies