Clinical Research Project Manager - Medix : Job Details

Position Summary:

The Project Manager is responsible for overseeing all aspects of clinical trial conduct at the TRIAD Center. This includes regulatory compliance, patient safety, data quality, and personnel management. The role involves independently managing clinical research studies across multiple sites, ensuring compliance with protocols, timelines, and institutional and federal regulations. The candidate will also support the development of research projects, from proposal applications to scientific study design and regulatory submissions. Additionally, this role requires significant leadership in managing clinical research teams and maintaining relationships with key stakeholders.

Key Responsibilities:

Study Team and Conduct:

• Develop and revise the organizational structure, collaborating with the Center Director to meet research study needs.
• Lead the study team (including physician investigators) to develop data elements for clinical studies.
• Provide independent oversight of study conduct, regulatory compliance, and record-keeping at the site or institution level.
• Oversee all stages of clinical protocol studies, including screening, recruitment, and enrollment.
• Ensure that informed consent, eligibility review, protocol implementation, IRB approval, and data safety monitoring plans (DSMPs) are followed.
• Assist in audit preparation, site visits, and monitoring activities.
• Ensure overall subject safety and compliance with human subject regulations.
• Communicate regularly with participating sites to discuss study conduct and follow-up on data issues.

Study Maintenance:

• Maintain source documents and study files for each patient.
• Correspond with the study sponsor, IRB, CRO, and other affiliated agencies.
• Work with other departments to ensure proper routing of protocols and obtain necessary data.
• Report unanticipated events and collaborate with investigators to implement DSMPs.
• Review incoming clinical data to identify trends or issues and verify data relevance and accuracy.

Qualifications:

Required Education and Experience:

• Bachelor's degree required.
• At least three (3) years of management experience in clinical research.

Knowledge, Skills, and Abilities:

• In-depth knowledge of FDA, ICH GCP, and other regulatory compliance guidelines.
• Strong understanding of federal regulations and IRB procedures.
• Excellent organizational, problem-solving, and leadership skills.
• Proficiency in negotiation, communication, and people management.
• Ability to handle diverse operations functions (e.g., resource management, finance).
• Ability to maintain confidentiality and obtain necessary training certificates (CITI, institutional credentialing).
• Proven track record of successful clinical trial management, including meeting study timelines and stakeholder satisfaction.

Preferred Qualifications:

• Master's degree, Ph.D., or M.D.
• 5+ years of experience managing and training clinical research staff.
• 5+ years of experience in cardiovascular research studies.
• Certification as a Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) is preferred.
• Regulatory Affairs Certification (RAC), CCRC, or Certified IRB Professional (CIP) is also a plus.

Soft Skills/Attributes:

• Must have management experience and the ability to support teams across multiple sites.
• Strong communication skills and the ability to foster collaboration.
• Ability to adapt to changing priorities and handle multiple projects efficiently.

Job Logistics:

• Schedule: Monday-Friday, 8 AM - 5 PM.