Clinical Research Coordinator – Human Genetics Metabolism, PA

1019118 SHIFT: Day (United States of America) 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. 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

Education Qualifications

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

Experience Qualifications

• At least four (4) years of clinical/research coordination experience - Required
• At least five (5) years of clinical/research coordination experience - Preferred

Skills 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 levels

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 receive an annual influenza vaccine. Learn more. EEO / VEVRAA Federal Contractor | Tobacco Statement SALARY RANGE: $61,360.00 - $78,230.00 Annually Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly. ------------------- At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits. Apply tot his job Apply To this Job