Lead, Clinical Research Associate in New York at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Lead, Clinical Research Associate based in United States.

This is a leadership-focused clinical research role overseeing monitoring and site management activities across clinical trials and investigations.
You will lead and develop a team of Clinical Research Associates while ensuring high standards of quality, compliance, and delivery.
The role combines people management with hands-on involvement in study execution, sponsor relationships, and operational oversight.
You will help ensure clinical activities remain aligned with protocols, Good Clinical Practice, regulatory requirements, timelines, and budgets.
The position offers the opportunity to influence monitoring strategy, resolve complex study issues, and strengthen operational processes.
You will collaborate closely with sponsors, clinical project managers, investigators, vendors, and internal cross-functional teams.
Success in this role requires strong leadership, sound clinical judgment, attention to detail, and a commitment to continuous improvement.

• Lead, supervise, mentor, and coach Clinical Research Associates and contractors, ensuring adherence to organizational policies, procedures, applicable regulations, and quality standards.
• Support recruitment, interviewing, onboarding, training, and ongoing professional development of CRA team members.
• Develop and implement function-specific training programs covering procedures, best practices, regulatory expectations, confidentiality requirements, and clinical research standards.
• Assign CRAs to clinical projects, monitor workloads, and coordinate resource allocation to support effective utilization and timely delivery.
• Conduct performance reviews, establish objectives, support career development, and promote individual accountability and professional growth.
• Act as an escalation point for direct reports, helping resolve operational challenges, deviations, quality issues, and corrective and preventive actions.
• Develop action plans and provide strategic oversight to improve monitoring services and achieve individual, team, and departmental objectives.
• Support the day-to-day execution of clinical monitoring activities, ensuring deliverables are completed on time, within quality and budget expectations, and in accordance with sponsor requirements.
• Oversee clinical study implementation and monitoring to ensure investigator and sponsor obligations are fulfilled in compliance with protocols, Good Clinical Practice, and applicable regulatory requirements.
• Ensure monitoring activities follow contracts, monitoring plans, standard operating procedures, and study-specific requirements.
• Support the development and review of monitoring plans and study materials, including site initiation materials and related documentation.
• Perform co-monitoring or CRA activities on selected studies when required.
• Maintain oversight of clinical trial management systems, including monitoring visits, queries, issues, and other study activity tracking.
• Review monitoring metrics and deliverables to identify quality trends, compliance gaps, and opportunities for improvement.
• Collaborate with sponsors, clinical project managers, study teams, investigators, vendors, and other stakeholders to resolve study issues and maintain project momentum.
• Support the planning and execution of investigator meetings, study team meetings, training sessions, and other project-related activities.
• Participate in audits and regulatory inspections, including preparation, coordination, response, and follow-up activities.
• Support regulatory submissions and other sponsor obligations in accordance with applicable requirements.
• Maintain accurate documentation, reporting, administrative records, and trial-related systems in line with internal and client requirements.
• Contribute to process improvement initiatives and promote a positive, collaborative, results-oriented environment.

• Bachelor’s degree in a biomedical, life sciences, or related discipline, or equivalent professional experience.
• At least 5 years of experience in clinical operations or a related discipline within a CRO or pharmaceutical environment, including a minimum of 3 years of on-site monitoring experience.
• Demonstrated people-management experience, including the ability to lead, mentor, coach, and develop clinical research professionals.
• Strong knowledge of Good Clinical Practice, 21 CFR Part 11, and other applicable clinical research and regulatory requirements.
• Hands-on experience conducting Feasibility Assessments, Site Qualification Visits, Site Initiation Visits, Routine Monitoring Visits, Close-Out Visits, and other types of clinical site visits.
• Experience with investigational product accountability, Trial Master File maintenance, safety reporting, and Serious Adverse Event handling.
• Ability to oversee monitoring activities while maintaining compliance with protocols, monitoring plans, SOPs, GCP, and regulatory requirements.
• Excellent written and verbal English communication skills, with the ability to communicate effectively with sponsors, investigators, internal teams, and other stakeholders.
• Strong organization, analytical judgment, multitasking, prioritization, and time-management abilities.
• Exceptional attention to detail combined with tact, diplomacy, and sound professional judgment.
• Demonstrated commitment to quality, reliability, continuous learning, and knowledge sharing.
• Ability to work effectively and independently in a dynamic environment while contributing positively to a collaborative team.
• Strong problem-solving skills and the ability to manage escalations, deviations, and complex study issues.
• Self-motivated and capable of managing competing priorities while maintaining adherence to project timelines.
• Strong computer literacy and willingness to maintain proficiency with required clinical and organizational systems.
• Ability to maintain strict confidentiality of subject data and sponsor/client information.
• Flexible and willing to travel for planned and occasional short-notice meetings and clinical site visits.

• Opportunity to lead and develop a team of Clinical Research Associates within a clinical research environment.
• Broad exposure to clinical trials, monitoring operations, sponsors, investigators, and regulatory activities.
• Leadership responsibility combined with opportunities for hands-on involvement in clinical study execution.
• Collaborative environment centered on integrity, trust, teamwork, and respect.
• Opportunities to contribute to process improvement and strengthen clinical monitoring practices.
• Ongoing professional development, training, and knowledge-sharing opportunities.
• Opportunity to work on diverse clinical research projects and support high-quality study delivery.
• Equal opportunity workplace committed to fair and inclusive employment practices.
• Role includes travel opportunities for clinical site visits, meetings, and project activities.