Clinical Research Site Manager
Key Responsibilities
- Direct daily site operations and provide leadership to improve productivity, operational efficiency, participant safety, and compliance with clinical research standards and regulatory requirements.
- Coordinate with cross-functional teams responsible for recruitment, business operations, financial planning, contracts, and quality assurance to achieve study milestones, enrollment objectives, activation timelines, budget expectations, and data quality standards.
- Monitor operational reports, performance metrics, and clinical trial management platforms to evaluate site activity, staff coverage, participant engagement, and completion of required study procedures.
- Manage staffing assignments, workload distribution, and team performance to ensure study commitments are met. Identify potential delays, quality concerns, resource limitations, and budgetary risks, escalating issues when appropriate.
- Coordinate initial and ongoing staff education related to study protocols, electronic and paper-based data collection, procedural guidelines, internal processes, and project timelines.
- Maintain compliance with established procedures, Good Clinical Practice (GCP), applicable federal regulations, privacy requirements, and organizational standards.
- Supervise research personnel and routinely assess adherence to study requirements, training expectations, operational procedures, and quality standards while identifying potential compliance concerns.
- Develop, implement, and monitor corrective and preventive action plans to address operational deficiencies and improve site-level performance.
- Lead personnel management activities, including recruitment, interviewing, onboarding, performance evaluations, employee development, coaching, and disciplinary actions when necessary.
- Oversee scheduling, attendance tracking, payroll coordination, and employee training to support appropriate staffing levels and consistent site operations.
- Partner with principal investigators and other clinical stakeholders to maintain participant safety, support protocol adherence, and achieve study objectives within established timelines.
- Apply critical thinking and problem-solving skills to identify operational challenges, assess risks, and implement practical solutions.
- Attend and contribute to leadership discussions, operational reviews, and site meetings, providing updates on performance, staffing, study progress, and areas for improvement.
- Perform additional responsibilities as needed to support clinical research operations.
Qualifications, Skills, and Experience
Minimum Qualifications
- Bachelor's degree and at least five years of clinical research experience, or an equivalent combination of education and relevant professional experience.
- At least two years of experience managing clinical research sites or overseeing site-level operations.
- English and Spanish bilingual proficiency is preferred.
Required Skills and Competencies
- Proficiency with common business software, email platforms, electronic health record systems, web-based applications, and clinical research technology.
- Strong computer skills, including the ability to type at least 40 words per minute.
- Excellent organizational, time management, project coordination, and problem-solving abilities, with the capacity to meet multiple deadlines.
- Strong written and verbal communication skills, including the ability to communicate effectively with research staff, investigators, participants, leadership, and external partners.
- Effective interpersonal, listening, and collaboration skills, with the ability to work independently and as part of a multidisciplinary team.
- Demonstrated ability to manage competing priorities, adapt to changing workloads, and maintain productivity in a fast-paced clinical research environment.
- Professional demeanor, self-motivation, accountability, and a consistent commitment to high-quality work.
- High standards of integrity, reliability, and sound professional judgment.
- Ability to operate with limited supervision, recognize operational challenges, and implement appropriate solutions.
- Ability to safeguard confidential records and sensitive information while adhering to applicable privacy requirements, including HIPAA.
Site Director- 258809 in Fredericksburg at Medix™
This position is listed as contract and onsite. It was posted 3 days ago.