Clinical Research Coordinator

Job Summary This role is 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 the study per protocols. Provide support to PI/sub‑I as requested at multiple clinics. This role is in clinic and works at the following locations: Los Alamitos, Anaheim Hills, Long Beach, and Newport Beach. 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. Assist 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 data in a timely manner; perform study monitoring in peer‑to‑peer inter‑rated methodology. Enter all data within 2 days of study visit by Research Coordinators and resolve queries within 2 days. 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. Education 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. Certified Clinical Research Coordinator (CCRC) designation a plus. Essential Skills and Abilities Committed to executing exceptional patient service and satisfaction. Ability to support the organization’s preferences and priorities. Ability to generate respect and trust from colleagues and leadership. Excellent listening, oral and written communication skills. Tactful, mature and able to interact well with diverse personalities. Able to exemplify professional behavior in all aspects of position. Computer literate with good keyboarding skills. Ability to operate basic office equipment such as a phone, fax, copier, printer etc. Must have a valid driver's license. Benefits Medical, Dental, and Vision insurance Short-term/Long-term disability Life and other voluntary plans 401(k) plan Employee Referral Program Paid Time-Off Company-Paid Holidays Equipment Operated Standard office equipment including computers, fax machines, copiers, printers, telephones, etc. Physical Requirements Must possess manual dexterity to operate office machines including computer and calculator; stooping and bending to handle files and supplies; and mobility to complete errands or deliveries. Includes handling of sharps and chemicals. Equal Employment Opportunity Platinum Dermatology Partners is committed to a policy of equal employment opportunities for applicants and employees. Employment decisions will comply with all applicable laws prohibiting discrimination in employment, including Title VII of the Civil Rights Act of 1964, the Age Discrimination in Employment Act of 1967, the Americans with Disabilities Act of 1990, the Immigration and Nationality Act, the California Fair Employment and Housing Act, and all other applicable state and federal laws. Platinum Dermatology Partners does not permit discrimination of any type against an employee because of any of the following legally protected characteristics: gender, race, color, religion, country of origin, mental disability, physical disability, marital status, gender identity, gender expression, ancestry, genetic information, medical condition, age, sexual orientation, or pregnancy. Please note that any offer of employment is contingent on the successful completion of pre‑employment background checks. #J-18808-Ljbffr The Voluntary Protection Programs Participants' Association, Inc