Senior Clinical Research Coordinator

Golden State Dermatology•Walnut Creek, CA

1d•$60 - $75•Onsite

About The Position

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. 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.

Requirements

BA/BS in an equivalent field or equivalent years of experience.
3 years of experience in pharmaceutical trials
Excellent interpersonal, organizational, problem-solving, and written/verbal communication/influence skills.
Proficiency in MS Word/Excel
Good Clinical Practices (GCP) Certifications

Nice To Haves

Experience working with CRO's is preferred.
Experience with electronic data capture/reviewing/interpreting data desired.
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).

Responsibilities

Travel to Walnut Creek frequently
Review protocols and feasibility questionnaires to assess operational readiness
Support budget, contract, and study start-up planning with operational input
Identify potential study risks early and communicate mitigation strategies
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
Lead study start-up activities, including feasibility assessments, site qualification, and site initiation
Prepare, submit, and maintain regulatory documents (IRB submissions, amendments, continuing reviews)
Ensure compliance with ICH-GCP, FDA regulations, sponsor, and institutional requirements
Maintain regulatory binders and essential documents.
Prepare and participation in monitor visits and sponsor site visits.
Contributes to GCP inspection-readiness activities.
Participate in all aspects of assigned clinical studies and ensure studies are completed on time, within budget.
Coordinate and oversee day-to-day study operations for multiple trials.
Serve as the primary point of contact for sponsors, CROs, and monitors.
Schedule and conduct study visits per protocol.
Ensure accurate execution of study procedures and protocol adherence.
Assist with the preparation of safety, interim and final study reports, and resolution of data discrepancies.
Receive and catalog study supplies, devices, and equipment.
Ship and handle laboratory material send out to central labs.
Oversee patient recruitment, screening, enrollment, and retention strategies
Obtain and document informed consent
Ensure participant safety and rights are protected throughout the study
Manage protocol deviations and corrective actions
Escort patient to local phlebotomy lab
Ensure timely, accurate data entry into EDC systems
Review data for completeness and resolve queries
Maintain source documentation that supports protocol and regulatory requirements
Prepare for and participate in monitoring visits, audits, and inspections
Identify, document, and report adverse events and serious adverse events per protocol and regulations
Ensure timely safety reporting to sponsors and IRBs
Implement quality control and quality assurance measures
Assist with CAPA development and implementation when needed
Track study budgets, patient stipends, and timely invoicing in collaboration with finance
Ensure study activities align with contractual and budgetary requirements
Provide guidance, training, and mentorship to junior CRCs and research staff
Assist with the development and implementation of SOPs and workflows
Support process improvement initiatives and operational efficiency
Coordinate study close-out activities
Ensure proper archiving of study records according to regulatory requirements