Job Details
Chicago Clinical Research Institute
Job Title: Clinical Research Site Director
Job Overview:
The Clinical Research Site Director will be responsible for the overall operation and management of our clinical research site. This includes leading the development and implementation of the study protocols, recruiting and retaining study participants, and ensuring the highest standards of quality and compliance. The Clinical Research Site Director will also be responsible for building and maintaining relationships with key stakeholders, including patients, investigators, sponsors, and regulatory agencies.
The Ideal Candidate:
- Possess the ability to lead the site successfully along with leading its staff to actualize their individual potential to grow the site collectively.
- Independent critical thinker who can leverage resources to execute on mission critical objectives.
- Proven track record of achieving excellence
- Ability to operate independently in a deadline-driven, demanding workplace while being adaptive and paying attention to detail.
- Dynamic thinker who takes a multi-discplinary approach to solving problems.
Key Responsibilities:
- Study operations: Lead the development and implementation of study protocols, ensuring compliance with Good Clinical Practices (GCPs) and applicable regulations.
- Patient recruitment and retention: Develop and implement strategies to recruit and retain study participants in collaboration with the study investigators and the study sponsor.
- Quality assurance: Ensure that the research site is following the study protocol, GCPs, and applicable regulations. Implement and maintain systems to ensure the integrity of the data.
- Regulatory compliance: Ensure that the research site is in compliance with applicable regulatory requirements, including institutional review board (IRB) approvals and FDA regulations.
- Staff management: Recruit the best research coordinators and supervise and mentor the research site staff, ensuring that they are properly trained and qualified to perform their duties.
- Stakeholder management: Build and maintain relationships with key stakeholders, including patients, investigators, sponsors, and regulatory agencies. Represent the research site at relevant meetings and conferences.
- Budget and Resource Management: Plan and manage the research site budget, ensuring that resources are allocated efficiently and effectively.
Qualifications:
- Minimum of 5 years of experience in a clinical research setting
- Strong understanding of GCPs and FDA regulations regarding the clinical trial process
- Experience in leading and managing clinical research studies
- Excellent organizational, communication, and leadership skills
- Strong problem-solving and critical-thinking abilities
- Ability to work independently and in a team environment
Salary: Negotiable