Clinical Research Coordinator

Golden State Dermatology is a physician-led and owned dermatology group rapidly expanding across California. We are a leading medical, surgical, and cosmetic dermatology group specializing in skin, hair, and nail conditions, Mohs micrographic surgery for the treatment of skin cancer, surgical and non-surgical cosmetic skincare, anti-aging, body contouring, and plastic surgery.

The Clinical Research Coordinator supports the conduct of clinical trials under the direction of the Principal Investigator and research leadership. This position is responsible for coordinating assigned studies and ensuring study activities are completed accurately, efficiently, and in accordance with study protocols, ICH-GCP guidelines, FDA regulations, and institutional requirements.

The Coordinator works closely with study participants, investigators, sponsors, CROs, monitors, and other research staff. Responsibilities include study start-up and regulatory activities, participant recruitment and study visits, source documentation and EDC entry, safety reporting, study supply management, monitoring visit preparation, and study close-out.

This position requires strong organization, attention to detail, communication, and problem-solving skills, as well as the ability to manage multiple priorities and proactively identify and escalate study-related issues. Frequent travel to the Walnut Creek study site is required.

Essential Responsibilities
Study Start-Up & Regulatory

• Support study feasibility and start-up activities.
•  Review study protocols and study materials to understand operational requirements.
• Prepare and maintain regulatory documents, including IRB submissions, amendments, and continuing reviews.
• Maintain regulatory binders and essential study documents.
• Complete study-specific training and maintain required training documentation.
• Assist with preparation for site initiation visits, monitoring visits, sponsor visits, audits, and inspections.
• Perform study activities in accordance with ICH-GCP, FDA regulations, study protocols, and applicable institutional requirements.

Study Conduct & Coordination

• Coordinate day-to-day activities for assigned clinical studies.
• Communicate with investigators, sponsors, CROs, monitors, and other study personnel regarding assigned study activities.
• Review and stay current on sponsor and CRO communications regarding study updates, including protocol amendments, revised regulatory documents, updated study materials, and changes to study procedures or requirements.
• Schedule and conduct study visits according to protocol.
• Ensure study procedures are completed accurately and within required timelines.
• Track study milestones, outstanding items, and required follow-up.
• Identify study issues, delays, or potential protocol concerns and escalate them promptly.
• Receive, organize, and maintain study supplies, devices, and equipment.
• Process and ship laboratory specimens and other study materials according to protocol requirements.

Subject Management

• Support participant recruitment, prescreening, screening, enrollment, and retention.
• Obtain and document informed consent when appropriately delegated by the Principal Investigator.
• Coordinate participant visits and study-related procedures.
• Maintain communication with participants regarding study visits and requirements.
• Protect participant rights, safety, privacy, and confidentiality.
• Document protocol deviations and assist with required follow-up and corrective actions.
• Escort participants to local approved study sites (phlebotomy and radiology) when required.

Data & Documentation

• Complete accurate and timely source documentation.
• Enter study data into electronic data capture (EDC) systems within required timelines.
• Review study data and documentation for accuracy and completeness.
• Respond to and resolve data queries promptly.
• Maintain organized study files and documentation suitable for sponsor monitoring and regulatory review.
• Ensure study documentation supports protocol and regulatory requirements.

Safety & Quality

• Identify and document adverse events and serious adverse events and promptly escalate them to the Principal Investigator.
• Complete required safety reporting to sponsors and IRBs according to applicable procedures and timelines.
• Review assigned study work for completeness, accuracy, and protocol compliance.
• Identify documentation or process discrepancies and assist with their resolution.
• Participate in corrective and preventive actions when applicable.

Monitoring & Sponsor Coordination

• Prepare study records and materials for monitoring visits.
• Participate in sponsor and CRO monitoring visits.
• Respond to monitor requests and follow up on action items within required timelines.
• Maintain clear and professional communication with sponsors, CROs, monitors, and study personnel.
• Escalate unresolved sponsor, operational, or regulatory issues to research leadership or the Principal Investigator.

Financial & Administrative Support

• Maintain accurate records of participant visits, study activities, and participant stipends.
• Prepare and submit invoices to sponsors/CROs for billable study activities in accordance with study budgets and contracts.
• Track sponsor payments and assist with payment reconciliation, including identifying and following up on outstanding or discrepant payments.
• Maintain documentation necessary to support study billing and financial reconciliation.

Study Close-Out

• Assist with study close-out activities.
• Resolve outstanding documentation and data items before study closure.
• Ensure study records are complete and organized for appropriate archiving.

Qualifications

• BA/BS or equivalent combination of education and relevant experience.
• At least 2 years of clinical research experience preferred, including experience with pharmaceutical or industry-sponsored clinical trials.
• Experience working with sponsors and CROs preferred.
• Working knowledge of ICH-GCP and clinical research regulations.
• Experience with electronic data capture systems and clinical trial documentation.
• Strong organizational skills and attention to detail.
• Ability to manage multiple studies, deadlines, and competing priorities.
• Strong problem-solving skills and ability to recognize when issues require escalation.
• Excellent written and verbal communication and interpersonal skills.
• Strong computer and digital literacy, including proficiency with Microsoft Office and Google Workspace (Docs, Sheets, Drive), PDF editing software, and web-based applications.
• Comfortable learning and using new software, including AI productivity tools such as Gemini, clinical trial platforms, sponsor portals, and electronic data capture systems.
• Strong technology problem-solving skills, including the ability to independently troubleshoot routine software, access, file-format, and workflow issues and appropriately escalate more complex IT problems.
• Ability and willingness to travel frequently to the Walnut Creek study site.

Clinical research certification such as ACRP-CP, CCRC, CCRP, or equivalent is preferred but not required. Maintenance of Good Clinical Practice (GCP) certification is required.

GSD strongly encourages employees to receive the COVID-19 primary series vaccination.
Golden State Dermatology participates in the E-Verify program. E-Verify is a free, web-based system that allows employers to confirm their employees’ eligibility to work in the United States. It does this by comparing information from an employee’s Form I-9, Employment Eligibility Verification, to records from the U.S. Department of Homeland Security (DHS) and Social Security Administration (SSA).

Golden State Dermatology is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants for employment and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic.