Clinical Research Coordinator- Billingual Spanish at Retina Sacramento MSO LLC in Sacramento, California

Job Description:

Come and join our team! We are a local growing private medical practice specializing in the diagnosis and treatment of patients with diseases of the retina and vitreous. We are looking for individuals who would like to establish a career in healthcare working with nationally recognized physicians. We provide on the job training giving you the ability to grow and advance your skills along with gaining innovative knowledge. Established in 1977, we have locations all over Northern California including Sacramento, Grass Valley, Roseville, Stockton, Modesto, Merced, Fairfield, Elk Grove, Folsom, Yuba City and Chico. Our physicians are nationally known, and we continue to be on the leading edge of retina care by utilizing the latest equipment and both participating in and designing new clinical trials to advance the state of care for retinal diseases. Join 250+ other team members working for our nationally recognized retina specialty practice in a fast paced, high volume medical office.

The research coordinator is primarily responsible for coordinating research patient visits according to both the ICH-GCP guidelines and the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.

We seek a full-time clinical research coordinator to support our clinical research department. Although you must be able to work independently, you will be working directly with physicians, patients, research coordinators, clinical and business office staff and with pharmaceutical sponsor representatives to correctly and efficiently execute clinical research protocols. Collaboration and being a team player are essential to the success of this role.

As our clinical research coordinator, you will assist in the planning, development and implementation of clinical research trials involving the study of agents to treat diseases of the retina, macula and vitreous.
Responsibilities:
Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the studyWorks with team member responsible for ordering study supplies (lab kits, shippers, etc.) to ensure adequate inventory is on handEnsures study staff is properly trained on study-related information (i.e. protocol, ICF, manuals, etc.) and that the training is documentedCreates, manages, and maintains source documents for each trialAttends teleconferences and Investigator Meetings as requested by research directorReviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protectionsWorks with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goalsScreens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility accuratelyEfficiently completes all study tasks delegated to them (i.e. scribing, VFQ, IOP, etc.)Conducts and/or participates in the informed consent process/discussion with research participants, including answering any questions related to the studyAssures that amended consent forms are appropriately implemented and signedActs as a secondary reviewer to provide oversight so that the ICF process is conducted accuratelyCollects data as required by the protocol and enters information into the electronic data capture (EDC) system in the specified timeframe indicated in the study contract.Oversees data and ensures that it is being entered correctly and resolves any queries issued within required timeframeCollects and reports ALL Adverse EventsCollects and reports ALL Serious Adverse EventsResponsible for ensuring all SUSAR/Safety Reports are acknowledged and reviewedCoordinates monitor site visits and assists with preparation of site visit documentationWorks with the monitor to make any corrections needed to meet requirements and deadlines as neededCollects updated medical history, adverse events and serious adverse events that need to be reported to the sponsor and IRB within required timeframeManages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor.