Job Description

We are a innovative, customer-centric, and growth oriented organization. Our goal is to "Unlock the Power of Excellence in Clinical Research".

Our work environment includes the following:

• Modern office setting
• Work-from-home days
• Growth opportunities
• Flexible Schedules

Apex Medical Research is seeking a dynamic, growth-driven, and experienced leader to lead the operations of its growing number of clinical research sites.

About Apex

Our Culture

Our culture can best be summarized in the following points:

• We believe in giving people autonomy to express their creativity and harness their drive in light of our mission.
• Growth is essential, and as the organization grows, so should the people that support it.
• We believe in fostering a culture of transparency, trust, and meritocracy.
• We believe in being anti-bureaucratic and maintaining efficiency and speed.

Job Overview

The COO will be responsible for the operations of our growing number of sites. This includes leading the development and implementation of the study protocols, recruiting and retaining study participants, and ensuring the highest quality and compliance standards. The COO will also build and maintain 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 collectively grow the site.
• 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: Ensure studies are being executed successfully.

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: Work with Director of QA to ensure the research site follows 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: 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

Job Type: Full-time

Pay: $147,883.00 - $165,229.00 per year

Benefits:

• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Professional development assistance
• Relocation assistance
• Vision insurance

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Chicago, IL: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Experience:

• Clinical Research: 3 years (Required)

Work Location: In person

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