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Platinum Dermatology Partners · 6 hours ago

Clinical Research Coordinator (48718)

Research - La Jolla - San Diego, CA 92121

Full-time

Onsite

Mid Level

$28/hr - $31/hr

3+ years exp

Platinum Dermatology Partners is a network of high-quality dermatology clinics that focus on collaborative and innovative ideas to drive growth. This role is responsible for performing all administrative aspects of clinical trial research studies based on the needs and goals of the Research Program, including subject recruitment, data collection, and compliance with study protocols.

Health CareHospitalInformation Technology

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 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 principal investigator and appropriate agencies. Notifies Director, sponsor and IRB of any serious adverse events

Assist physician with all procedures to include excisions, injections, laser treatments, wound care, post-op care and dressing changes. Set up exam room for 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 physician’s schedule to maintain 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 in timely manner data entry, perform study monitoring in peer-to-peer inter-rated methodology

Enter all data within 2 days of study visit by Research Coordinators and query resolution performed within 2 days of query. Random QC monitoring process to be established by 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

Bachelor's DegreePhlebotomy techniquesIRB regulatory submissionGCP knowledgeCertified Clinical Research CoordinatorComputer literacyCommunication skillsTeam collaboration