Job DetailsJob Location: Ygnacio Valley Road GSM - WALNUT CREEK, CA 94598Position Type: Part TimeSalary Range: $60.00 - $75.00 Hourly
Golden State Dermatology is a physician-led and owned dermatology group rapidly expanding across California, with over 40 locations. 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.
Approximately 12-24 hours per week
The Senior Clinical Research Coordinator is the subject matter expert in complex clinical trial activities, following protocol and Principal Investigator directions. Strictly adheres to protocols, ICH-GCP guidelines, and FDA regulations. This role manages the full study lifecycle from conducting feasibility assessments and site qualification to coordinating day-to-day visit activities and overseeing study close-out. As a primary liaison for sponsors and CROs, the Senior CRC manages patient recruitment, informed consent, and safety reporting while ensuring high-quality data entry and query resolution in EDC systems. Beyond study conduct, the position involves preparing and maintaining essential regulatory documents and supporting financial tasks such as budget planning and invoicing.
The Coordinator implements quality assurance measures, participates in audits and periodic sponsor/CRO reviews, and identifies operational risks to ensure compliance. Additionally, this role provides mentorship and training to junior staff, develops standard operating procedures, and requires frequent travel to the Walnut Creek study site. Candidates must hold a BA/BS, and three years of pharmaceutical trial experience.
Essential Responsibilities-
Non-Study Responsibilities
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Travel to Walnut Creek frequently
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Review protocols and feasibility questionnaires to assess operational readiness
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Support budget, contract, and study start-up planning with operational input
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Identify potential study risks early and communicate mitigation strategies
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Participate in providing guidelines for assessing the adequacy of potential clinical investigators and sites, including evaluating facilities, personnel, patient referral base, and adherence to Good Clinical Practices (GCP). Study Start-Up & Regulatory
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Lead study start-up activities, including feasibility assessments, site qualification, and site initiation
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Prepare, submit, and maintain regulatory documents (IRB submissions, amendments, continuing reviews)
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Ensure compliance with ICH-GCP, FDA regulations, sponsor, and institutional requirements
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Maintain regulatory binders and essential documents.
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Prepare and participation in monitor visits and sponsor site visits.
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Contributes to GCP inspection-readiness activities.
Study Conduct & Coordination
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Participate in all aspects of assigned clinical studies and ensure studies are completed on time, within budget.
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Coordinate and oversee day-to-day study operations for multiple trials.
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Serve as the primary point of contact for sponsors, CROs, and monitors.
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Schedule and conduct study visits per protocol.
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Ensure accurate execution of study procedures and protocol adherence.
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Assist with the preparation of safety, interim and final study reports, and resolution of data discrepancies.
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Receive and catalog study supplies, devices, and equipment.
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Ship and handle laboratory material send out to central labs.
Subject Management
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Oversee patient recruitment, screening, enrollment, and retention strategies
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Obtain and document informed consent
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Ensure participant safety and rights are protected throughout the study
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Manage protocol deviations and corrective actions
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Escort patient to local phlebotomy lab
Data & Documentation
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Ensure timely, accurate data entry into EDC systems
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Review data for completeness and resolve queries
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Maintain source documentation that supports protocol and regulatory requirements
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Prepare for and participate in monitoring visits, audits, and inspections
Safety & Quality Oversight
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Identify, document, and report adverse events and serious adverse events per protocol and regulations
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Ensure timely safety reporting to sponsors and IRBs
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Implement quality control and quality assurance measures
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Assist with CAPA development and implementation when needed
Financial & Administrative Oversight
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Track study budgets, patient stipends, and timely invoicing in collaboration with finance
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Ensure study activities align with contractual and budgetary requirements
Leadership & Mentorship
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Provide guidance, training, and mentorship to junior CRCs and research staff
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Assist with the development and implementation of SOPs and workflows
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Support process improvement initiatives and operational efficiency
Close-Out
QUALIFICATIONS
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BA/BS in an equivalent field or equivalent years of experience.
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3 years of experience in pharmaceutical trials
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Experience working with CRO's is preferred.
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Excellent interpersonal, organizational, problem-solving, and written/verbal communication/influence skills.
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Proficiency in MS Word/Excel
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Experience with electronic data capture/reviewing/interpreting data desired.
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Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA); OR ACRP Certified Professional, Certified Clinical Research Associate, Certified Clinical Research Coordinator, Certified Principal Investigator, ACRP Medical Device Professional, or ACRP Project Manager from Association of Clinical Research Professionals (ACRP); OR Certified in Healthcare Compliance (CHC) from Healthcare Compliance Association (HCCA).
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Good Clinical Practices (GCP) Certifications
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.
Qualifications
