Clinical Research Coordinator (50396)

Platinum Dermatology Partners LLC•San Diego, CA

5d•Onsite

About The Position

This role is responsible for performing all administrative aspects of clinical trial research studies based upon needs and goals of the Research Program. Tasks include, but are not limited to, recruitment completion of database logs for pre-screens, scheduling, consents, and close out of study per protocols. Provide support to PI/sub-I as requested at multiple clinics.

Requirements

Bachelor's Degree required.
Health Sciences background preferred.
3 years prior experience
knowledge of phlebotomy techniques
Knowledge of IRB regulatory submission process, GCPs, and CFR related to research.
Must have a valid driver's license.

Nice To Haves

Certified Clinical Research Coordinator (CCRC) designation a plus.

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.