​​Clinical Research Coordinator 2​​ - Pediatrics

About the role

The Pediatric Clinical Trials Office (Peds CTO) is an existing centralized support office that provides services and high-level guidance to individuals involved in human subjects research. The Peds CTO is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research.

Responsibilities

• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications, ensuring compliance with federal regulations and institutional policies.
• Captures, processes, ships and stores specimens to appropriate laboratories according to established aseptic techniques.
• Coordinates and may participate in quality assurance reviews, including site visits, monitoring visits, and audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
• Prepares program conference lists for multidisciplinary conferences and workshops.
• May assist in the training of new or backup coordinators.
• Accountable for all tasks in moderately complex clinical studies.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence.
• Contributes to the problem solving on assigned clinical research studies and tasks.
• Performs other related work as needed.

Requirements

• Minimum requirements include a college or university degree in related field.
• Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Preferred Qualifications

• Education: Bachelor’s Degree.
• Experience: 2 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator-initiated; industry-sponsored; multi-site trials).

Benefits

• Benefits Eligible Yes

Pay

• Pay Rate Type: Salary
• FLSA Status: Exempt
• Pay Range: $60,000.00 - $75,000.00