SoTalent
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
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