Lead, Clinical Research Associate

Accountabilities

• • 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.

  Requirements

  • 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.

  Benefits

  • 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.