Fractional clinical research site director

Fractional Clinical Research Site Director / Senior Clinical Research Coordinator

Organization:
Specialists in Dermatology (SID)

Location:

Tucson, Arizona

Schedule:

Part-time / fractional - approximately 10–20 hours per week initially Work arrangement:
Hybrid, with regular on-site availability required

Reports to:

Principal Investigator and practice leadership

About the Opportunity

Specialists in Dermatology is a large, physician-owned practice in Tucson providing medical dermatology, surgical dermatology, Mohs surgery and aesthetic services. Led by Weimin Hu, MD, PhD, a board-certified dermatologist and Mohs surgeon, SID is building a clinical research program in dermatologic drugs, biologics, medical devices and procedural treatments. Dr. Hu will serve as Principal Investigator, and this role works directly with him rather than through layers of research administration.

We have the patient population, the physician expertise and the institutional commitment. What we need is an experienced research professional to build the operation around them.

This is not a study-coordinator position with a title attached. The first year is infrastructure work: assessing readiness, writing the SOPs, building regulatory systems, opening sponsor and CRO relationships, and getting the site through qualification and initiation so it can enroll its first participants well. The right candidate has personally done this at the site level, ideally in dermatology, and is comfortable working without an existing research department to lean on.

Responsibilities

Program design and infrastructure

• Assess trial readiness and build a practical startup plan
• Develop research SOPs, workflows and quality-control systems
• Establish regulatory binders, electronic study records, and investigational-product, specimen and equipment workflows
• Build a staffing, equipment and financial plan for sustainable growth

Study acquisition and startup

• Identify and pursue appropriate dermatology drug, biologic and device studies
• Complete sponsor and CRO feasibility questionnaires and review protocols for operational fit with our patient population
• Develop study budgets and support clinical-trial agreement negotiations
• Coordinate central IRB submissions, amendments, continuing reviews and closeout
• Prepare the site for qualification, initiation, monitoring and audit visits

Study conduct

• Build recruitment and prescreening workflows using SID's existing patient population
• Coordinate study visits, ensure protocol compliance, and support informed consent and source documentation
• Manage EDC entry, sponsor queries, adverse-event documentation and safety reporting
• Work with the Principal Investigator with clear documentation of delegated responsibilities
• Train physicians and staff in research procedures and documentation
• Help recruit and train a full-time research coordinator as the program grows

Required Qualifications

• Five or more years of clinical-research experience at an investigative site
• Direct responsibility for the startup and conduct of industry-sponsored trials
• Strong working knowledge of ICH-GCP, FDA requirements and human-subject protections
• Experience with IRB submissions, regulatory and source documentation, and EDC systems
• Experience preparing for sponsor monitoring visits and regulatory audits
• Demonstrated success recruiting and retaining trial participants
• Ability to build systems independently in a new research environment, and to work on-site in Tucson when required

Preferred Qualifications

• Dermatology, inflammatory skin disease, skin cancer, aesthetics, wound healing or medical-device study experience
• Experience helping launch a new independent research site
• Established relationships with dermatology sponsors, CROs or site networks
• Experience with feasibility, budget development and contract negotiation
• ACRP CCRC, ACRP-CP or SOCRA CCRP certification
• Nursing, healthcare or life-science background

What Success Looks Like

By the end of the initial engagement, the selected candidate will have completed a readiness assessment, established essential SOPs and regulatory infrastructure, built a targeted sponsor and CRO outreach pipeline, submitted SID for appropriate study opportunities, prepared the site for qualification and initiation visits, and helped activate and enroll our first clinical trials — along with a staffing and financial plan for what comes next.

Compensation

Competitive hourly or monthly consulting compensation based on experience, qualifications and scope of work; we are open to either…