Important Details:
- This is a 100% ON-SITE Research Site Manager role
- The Site Manager will also act as CRC as needed
- This position is ONLY open to LOCAL candidates, relation candidates will NOT be considered
- US based experience only
- Open to Senior CRC or Lead CRC that are ready for a management role
Position Summary
The Clinical Research Manager provides leadership and oversight to ensure the successful conduct of clinical trials across multiple therapeutic areas. This role focuses on driving study performance, maintaining patient safety, ensuring compliance with GCP and regulatory standards, and promoting operational efficiency. The position requires strong collaboration with cross-functional teams to achieve study milestones, deliver quality data, and uphold the highest ethical and procedural standards. This individual will also serve as a Clinical Research Coordinator (CRC) as needed to support research staff and maintain study continuity.
Key Responsibilities
- Provide team leadership and management support focusing on study performance, patient safety, and compliance with protocols, GCP, and regulatory requirements.
- Collaborate with internal departments including Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality Assurance to coordinate deliverables, meet study milestones (such as site activation and enrollment targets), manage budgets, and ensure data quality.
- Monitor performance dashboards and trial management systems to track site and patient activities, staff coverage, and operational execution, ensuring timely updates across all study metrics.
- Oversee study team assignments, workload distribution, and performance, proactively identifying risks to delivery, quality, or budget and implementing mitigation strategies as needed.
- Support initial and ongoing training for site staff on protocol details, CRF completion, SOPs, clinical plans, guidelines, and study timelines.
- Ensure strict adherence to company policies, SOPs, GCP, and FDA regulations.
- Evaluate site-level processes for compliance, training, and quality performance, and assist in developing and executing corrective or preventive action plans.
- Manage people operations including timecards, attendance tracking, onboarding, performance evaluations, employee development, and disciplinary actions as needed.
- Partner with investigators and clinical teams to safeguard patient safety and achieve project objectives within established timelines.
- Utilize strategic thinking and problem-solving skills to identify risks and implement effective mitigation plans.
- Participate in leadership and site meetings, providing updates and insights on study progress and team performance.
- Perform all other duties as assigned to support organizational and departmental goals.
Qualifications and Experience
- Bachelor’s degree and at least 2 years of clinical research experience, or an equivalent combination of education and experience, required.
- Minimum of 2 years of experience as a Clinical Research Coordinator (CRC).
- At least 1 year of management experience within a clinical research setting is highly preferred.
- Bilingual proficiency in English and Spanish is a plus.
Skills and Competencies
- Proficient with Microsoft Office applications, email, EHR systems, and web-based platforms; able to type 40 or more words per minute.
- Strong organizational, time management, and project management skills with the ability to meet strict deadlines.
- Excellent written, verbal, and interpersonal communication skills.
- Effective at managing multiple priorities and adapting to changing workloads.
- Self-motivated, professional, and dependable, with a strong sense of integrity and accountability.
- Demonstrated ability to work independently while maintaining collaboration across teams.
- Skilled at handling confidential and sensitive information in accordance with HIPAA guidelines.
*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
*As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.