Job Description

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

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