Job Description
Our client is looking for a seasoned clinical research professional to oversee daily operations within a growing clinical trials unit. This leadership role is responsible for managing a team of research coordinators and specialists, ensuring high-quality execution of research protocols involving human participants. The position requires expertise in study coordination, regulatory compliance, and team development, with a focus on process improvement and operational excellence across all phases of research.
Key Responsibilities
- Supervise a multidisciplinary team involved in clinical trial execution, including study coordinators, research specialists, and associates
- Lead the assignment and management of clinical studies, ensuring all project milestones and regulatory requirements are met
- Coordinate the planning, initiation, and closure of clinical research studies, supporting principal investigators and study teams throughout the lifecycle of each project
- Deliver ongoing training to staff on research procedures, ethical standards, and Good Clinical Practice (GCP) guidelines
- Collaborate with investigators and operational leadership to assess protocol feasibility, resource planning, and compliance with institutional and federal standards
- Act as a primary point of contact for study monitors, sponsors, and regulatory agencies
- Review study protocols and contribute to operational strategy, including risk assessment and mitigation planning
- Ensure timely and accurate data collection, entry, and reporting across assigned clinical studies
- Oversee documentation practices and support the development of internal SOPs and standardized workflows
- Participate in subject recruitment and ensure informed consent procedures are followed
- Assist in budget planning, productivity monitoring, and identifying opportunities for efficiency improvements
- Maintain accurate study records, including regulatory binders, case report forms, and subject files
- Facilitate effective communication between study stakeholders, including sponsors, investigators, and institutional departments
- Support quality assurance and audit readiness by ensuring adherence to study protocols and data integrity standards
Required Qualifications
- Bachelor's degree or higher and a minimum of 5 years’ experience in clinical research
- – OR –
- At least 9 years of hands-on research experience in lieu of a degree
- Certification from ACRP or SOCRA required within 6 months of start date
- Completion of IATA Dangerous Goods Regulations (DGR) training within 3 months of hire
- 4–7 years of clinical trial experience in hospital, academic, CRO, or industry settings
- Proven background in managing complex research studies and cross-functional teams
- Familiarity with cooperative group studies and early-phase trial coordination
- Experience with performance and productivity tracking tools or systems
Preferred Qualifications & Skills
- Clinical research certification (e.g., CCRC, CCRP, CRA) preferred upon hire
- Bilingual communication skills (English/Spanish) are a plus
- Prior experience in pediatric research or specialized areas like neurology, oncology, or neurosurgery
- Familiarity with electronic data capture platforms such as REDCap and clinical trial management systems
- Proficient in Microsoft Office Suite and commonly used research software tools
- Understanding of Phase I clinical trials and regulatory frameworks including FDA and NIH requirements
- Skilled in developing training materials and delivering protocol-specific education to clinical teams
- Excellent problem-solving, organizational, and leadership abilities
- Able to work independently, apply scientific logic to operational challenges, and ensure research integrity
- Willingness to work flexible or extended hours as required by study timelines
Please note: This job posting is just a preview of the full scope of the position. A comprehensive job description is shared by a member of our team