Job Description

Overview

We are seeking an experienced Clinical Research Manager who will also function as the Lead Clinical Research Coordinator (CRC) for a growing clinical trials program within a multi-physician dermatology practice.

The program currently manages approximately 6–7 active Phase III clinical trials with plans for significant expansion over the next 2–3 years. This role combines hands-on trial coordination with operational leadership, working closely with physician investigators, sponsors, and research staff.

The ideal candidate is a highly organized senior CRC capable of running trials independently while helping build and scale a growing clinical research program.

Key Responsibilities :

     -Trial Operations

• Serve as Lead CRC for active clinical trials

• Coordinate subject visits, assessments, and lab processing

• Maintain source documentation and ensure protocol compliance

• Manage EDC data entry and query resolution

• Prepare for and host sponsor monitoring visits

Regulatory and Study Startup

• Prepare and manage IRB submissions and regulatory documentation

• Assist with study startup activities, feasibility questionnaires, and site initiation

• Maintain regulatory binders and delegation logs

• Ensure compliance with GCP, FDA, and sponsor requirements

Sponsor and CRO Interface

• Serve as primary contact for sponsors, CROs, and monitors

• Coordinate monitoring visits and manage follow-up items

• Track protocol updates and amendments

Program Management

• Supervise and mentor junior research staff

• Work with physician investigators to coordinate trial activity

• Help optimize workflow, documentation, and study execution

• Assist with trial feasibility and program growth

Financial Tracking

• Track patient visit milestones and payments within the CTMS

• Ensure study activities are properly documented for accurate invoicing

Trial Development and Budget Support

• Assist physician investigators with study feasibility assessments

• Support evaluation of new clinical trial opportunities

• Review study budgets to ensure adequate reimbursement for procedures

• Coordinate with leadership on budget negotiation and contract execution

• Track potential trial opportunities and assist with study startup planning

Required Experience

• 5+ years of clinical research experience as a Clinical Research Coordinator (CRC)

• Experience coordinating industry-sponsored clinical trials

• Strong familiarity with GCP, FDA regulations, and IRB processes

• Experience interacting with sponsors, CROs, and clinical monitors

• Ability to manage multiple active studies simultaneously

• Excellent organizational and communication skills

Preferred Experience

• Experience as Lead CRC or Clinical Research Manager

• Experience with Phase II–III industry trials

• Dermatology clinical trial experience (preferred but not required)

• Experience with Clinical Trial Management Systems (CTMS)

• Experience supervising research staff

Personal Attributes We Are Seeking

• Highly organized and detail-oriented

• Comfortable operating independently in a physician-led environment

• Strong communicator with sponsors and monitors

• Proactive problem solver who can help build systems and processes

• Interested in helping grow and scale a clinical research program

How to Apply

For more information or to discuss this opportunity, please contact:

Chelsey Haibeck📧 chelsey.haibeck@gogpac.com📞 605-501-4307

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations. GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.