Senior Clinical Research Coordinator (51328)

Platinum Dermatology Partners LLC•San Diego, CA

49d•$38 - $41•Onsite

About The Position

Responsible for performing all administrative aspects of clinical trial research studies based upon the 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.

Requirements

Bachelor's Degree required.
3 years of prior experience; knowledge of phlebotomy techniques
Knowledge of the IRB regulatory submission process, GCPs, and CFRs related to research.

Nice To Haves

Health Sciences background preferred.
Certified Clinical Research Coordinator (CCRC) designation is 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 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.