Senior Clinical Research Project Coordinator

Job Opportunity:

We are seeking a highly skilled and experienced Senior Clinical Research Manager to lead and manage clinical trials and research studies.

About the Role:

• Clinical Trial Management:
  • Plan, initiate, and manage clinical research projects from start to finish, ensuring timely completion and compliance with regulatory standards.
  • Coordinate and oversee the execution of clinical trials, guaranteeing adherence to protocols, timelines, and budgets.
  • Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards, providing oversight on the recruitment, enrolment, and monitoring of clinical trial subjects.
  • Manage relationships with clinical research organizations (CROs), investigators, and external vendors, fostering effective collaboration and communication.
• Team Leadership:
  • Lead and mentor clinical research staff, ensuring they are trained and performing effectively, assigning tasks and responsibilities based on project needs.
  • Develop training programs and provide ongoing professional development for research teams, promoting continuous improvement and process optimization.
• Regulatory Compliance:
  • Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications, ensuring timely reporting of adverse events.
  • Monitor compliance with federal, state, and local regulations, as well as company policies, guaranteeing that the study meets ethical and regulatory standards.
• Study Design & Protocol Development:
  • Work with scientific and medical teams to develop clinical trial protocols, ensuring they meet study objectives, regulatory standards, and ethical guidelines.
  • Evaluate feasibility and risk of proposed studies, identifying areas for process improvement and implementing best practices to optimize research efficiency and compliance.
• Data Management and Reporting:
  • Ensure data collection, monitoring, and analysis are conducted efficiently and accurately, reviewing and analyzing clinical trial data to ensure quality and integrity.
  • Prepare and present progress reports to senior leadership and stakeholders, highlighting key findings and recommendations.
• Budget and Resource Management:
  • Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints, overseeing resource allocation, including personnel, equipment, and materials.
• Collaboration and Communication:
  • Foster open communication between internal teams, external partners, and key stakeholders, resolving any issues related to clinical trial execution and providing solutions.

Key Qualifications:

• Extensive experience in clinical trial management, team leadership, and regulatory compliance.
• Proven track record of success in leading and managing cross-functional teams, ensuring effective collaboration and communication.
• Strong understanding of Good Clinical Practice (GCP), regulatory requirements, and ethical standards.
• Excellent problem-solving and analytical skills, with the ability to identify areas for process improvement and implement best practices.
• Effective communication and interpersonal skills, with the ability to foster open communication and resolve conflicts.

What We Offer:

• A dynamic and supportive work environment, with opportunities for professional growth and development.
• Competitive salary and benefits package, reflecting your value to the organization.
• Recognition and reward for outstanding performance and contributions.

Contact Us:

To learn more about this exciting opportunity, please submit your application, including your resume and a cover letter outlining your qualifications and experience.