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Platinum Dermatology Partners · 1 day ago

Senior Clinical Research Coordinator (48749)

Research - La Jolla - San Diego, CA 92121

Full-time

Onsite

Mid, Senior Level

$30/hr - $34/hr

3+ years exp

Platinum Dermatology Partners is a network of high-quality dermatology clinics focused on collaborative and innovative growth. They are seeking a Senior Clinical Research Coordinator responsible for performing all administrative aspects of clinical trial research studies, including subject recruitment, data collection, and ensuring compliance with FDA guidelines.

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Responsibilities

Perform all research coordinator duties required to adhere to FDA guidelines and study protocols, and facilitate the daily clinical trial activities required to conduct the study, including, but not limited to:

Subject recruitment, screening, and enrollment

Collection of laboratory specimens, informed consent, and other data from the subject

Maintenance of source documents, including CRF (case report form) completion and review for accuracy

Participation in site monitoring visits and audits

Documentation of laboratory and histological procedures. Ensure accurate labeling of slide photos

Filing and maintenance of all study-related documents

Documents adverse events and notifies the principal investigator and appropriate agencies

Notifies Director, sponsor, and IRB of any serious adverse events

Assist the physician with all procedures, including excisions, injections, laser treatments, wound care, post-op care, and dressing changes

Set up the exam room for the specific procedure as indicated

Provide patient education and literature. Take pre- and post-treatment pictures

Clean pack and sterilize instruments. Assists in cleaning rooms

Monitor the physician’s schedule to maintain a timely flow

Ensure studies are conducted according to protocol and in accordance with GCP, ICH, and FDA guidelines. Ensure IRB guideline and SOP compliance

Ensure all study timelines are met, and study folders are kept updated and accurate

Work closely with the physician(s) and medical provider(s) assigned to the study

Oversee, participate, and enter data on time, perform study monitoring in peer-to-peer inter-rated methodology

Enter all data within 2 days of the study visit by the Research Coordinators, and query resolution is performed within 2 days of the query. Random QC monitoring process to be established by the Director and conducted by Research Coordinators in peer-to-peer inter-rated methodology

Perform other tasks/duties as requested or assigned by PI/sub-I and Director

Must be able to travel to oversee studies in multiple sites as required

Coordinate study schedules with practice personnel

Train other team members on study protocols and visits

Qualification

Clinical Research CoordinationPhlebotomy TechniquesIRB Regulatory SubmissionCertified Clinical Research CoordinatorGCP KnowledgePatient ServiceComputer LiteracyCommunication SkillsTeam Collaboration