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 Supervisor 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.
Responsibilities:
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Responsible for overseeing day-to-day research activities, program operations, and administration.
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Ensures clinical research studies are conducted efficiently and in compliance with FDA and GCP guidelines.
- Maintains current knowledge of Federal, State, and institutional guidelines and requirements governing research.
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Assists Department Regulatory Coordinator with the preparation and maintenance of regulatory documentation for submission for review by the Institutional Review Board (IRB) and other required review committees. This includes new, renewals, amendments, modifications, and revisions of protocols, descriptions of study, investigational drug information, HIPAA documentation and development of consent forms consistent with legal, Human Subjects Review Committee and Department of Health and Human Services (DHHS) requirements.
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Assists the Clinical Trial Manager and Principal Investigators in providing information to sponsors and vendors during study startup, conduct and closeout process.
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Ensures the study site operates at RCA expected levels of service, timeliness, and accuracy.\
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Supervises clinical research staff by setting goals, conducting regular meetings, and monitoring performances.
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Assists the Clinical Trials Director with study staff hiring, training, and annual evaluations.
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Updates site study assignment log and trial master file in Google Drive.
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Manages site protocol deviation tracking and ensures corrective action plans are implemented.
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Evaluate team environment and implement team building activities.
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Facilitates visits from sponsors, CROs, RCA and other stakeholders.
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Initiates and oversees study site purchase order process for supplies and devices.
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Provides weekly reports to the Clinical Trial Director.
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Participates in meetings with other supervisors and attends RCA annual National meetings and required training.
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Strong critical thinking and leadership skills
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2 years Clinical Research or Regulatory Coordinator experience preferred
Minimum Requirements:
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High School diploma or the equivalent
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At least 2 years of clinical research coordinator experience or CRCC Certification/CCRP Certification
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This position requires a valid California driver’s license, a reliable vehicle, and current auto insurance.
Physical Requirements:
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Must be able to stand for long periods of time
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Must be able to write
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Must be able to hold arms at shoulder height
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Must be able to communicate via telephone
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Must have manual dexterity to work with ophthalmic equipment
Full-time immediate employee benefits:
Paid Time Off (PTO) 13 days per year, as accrued.
7 Paid Holidays per year.
Scrub Allowance
Ability to participate in company 401k plan offered through Fidelity.
On the first of the month following 30 days of employment benefits:
Medical insurance – employer pays 95% of premium of base HMO plan for employee (dependent coverage available for purchase).
Group dental, vision, life, and accident plans available for purchase.
Flexible Spending Account participation available.
Allows pre-tax deferrals of amounts for medical, dental or vision premiums
Allows pre-tax deferrals for dependent care expenses, subject to limitations
After 90 days of employment – Paid Sick Leave of 5 days per year.
After one year of service – 401K Plan Safe Harbor contribution (3% of annual earnings) received after plan year ends.
