Clinical Research Coordinator - Human Genetics Metabolism

Children’s Hospital of Philadelphia•Philadelphia, PA

14d•$61,360 - $78,230

About The Position

Clinical Research Coordinator III 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 does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means. A Brief Overview This role will primarily work on mRNA clinical trials for two metabolic disorders, methylmalonic acidemia and propionic acidemia. These trials provide mRNA infusions to participants, currently on an every 2 week schedule. You will independently manage communication with potentially eligible participants, enrollment, coordination of study procedures, and regulatory submissions for protocol amendments and other updates. You will have primary responsibility for the methylmalonic acidemia clinical trials and will work closely with the team covering propionic acidemia clinical trials, both providing and receiving support as needed depending on enrollment numbers on each study.

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

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