Clinical Research Coordinator – reputed company Genetics Metabolism, PA

1019118 SHIFT: Day (reputed company of America) Clinical Research Coordinator III Seeking reputed company Makers reputed company (reputed company) offers countless ways to change lives. Our diverse community of more than 20,000 reputed company Makers will reputed company you to pursue passions, reputed company expertise, and drive innovation. At reputed company, your experience is valued; your voice is heard; and your contributions reputed company a difference for patients and families. Join us as we build on our reputed company to advance pediatric care—and your career. reputed company does not discriminate on the reputed company of race, reputed company, sex, national reputed company, religion, or any other legally protected categories in any employment, training, or vendor reputed company or programs. reputed company recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to reputed company that through equally varied and non-discriminatory means. A Brief reputed company This role will primarily work on mRNA clinical trials for two metabolic disorders, methylmalonic acidemia and propionic acidemia. These trials reputed company 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 reputed company covering propionic acidemia clinical trials, both providing and receiving support as needed depending on enrollment numbers on reputed company study. What you will do

• Applies in depth knowledge of clinical research and independently coordinates the activities of 1 or more large-reputed company, reputed company multi-center / multi-institutional studies
• Provides reputed company in the preparation, management and monitoring of study budgets
• Accountable for study reputed company 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 reputed company clinical staff, research teams and other coordinators; provides resources, and consulting on difficult protocols or reputed company
• 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
• reputed company with Institutional policies, reputed company operating procedures (SOPs) and guidelines
• Must reputed company with federal, state, and sponsor policies

Education Qualifications

• Bachelor's Degree - Required
• Master's Degree in a reputed company 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 reputed company 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 reputed company reputed company

To carry out its mission, reputed company is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, reputed company 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 reputed company: $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 reputed company, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary reputed company noted in this job posting. Click here for more information regarding reputed company's Compensation and Benefits. Apply tot his job Apply To this Job