Clinical Research Supervisor- Chico

Sacramento Native American Health Center, Inc; Sacramento (CA); On-site; USD 44,000 - 69,000; Full time

Benefits offered by this job

PTO 13 days

Holiday pay

Scrub allowance

401k plan

Medical insurance

Job summary

Sacramento Native American Health Center, Inc. is seeking a Research Coordinator to oversee day-to-day clinical research activities within a retina-focused practice.

The role involves coordinating patient visits, ensuring FDA and GCP compliance, and maintaining regulatory records in line with IRB requirements. The ideal candidate has 2+ years of clinical research coordination experience (CRCC/CCRP) or equivalent, a valid California driver’s license, and a readiness to contribute to a growing,

Qualifications

• Strong critical thinking and leadership skills.
• At least 2 years of clinical research coordinator experience or CRCC/CCRP certification.
• California driver’s license required.

Responsibilities

• Oversee day-to-day research activities, program operations and administration.
• Ensure studies are conducted in compliance with FDA and GCP guidelines.
• Coordinate recruitment, scheduling, and data-entry for studies.
• Maintain regulatory documentation for IRB and other required reviews.
• Assist with site start-up activities and feasibility assessments.

Skills

Critical thinking

Leadership

Education

High School diploma

Job description

• Base Pay $32.00 - $50.00 / Hour
• Employee Type Nonexempt FT

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.

Responsibilities

• Responsible for overseeing day-to-day research activities, program operations, and administration.
• Ensures clinical research studies are conducted efficiently and in compliance with FDA and GCP guidelines.
• Oversees the recruitment, scheduling, and data-entry process for clinical research studies.
• Maintains current knowledge of Federal, State, and institutional guidelines and requirements governing research.
• 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.
• Coordinates and supports staff of site selection and startup activities such as: completion of site feasibility questionnaires, review of study protocols, preparation of clinical trial feasibility assessments, preparation of sponsor documents, coordination of pre-study site visits, preparation, distribution and completion of financial disclosures
• Maintains site feasibility for ongoing and future studies.
• Assists the Clinical Trial Manager and Principal Investigators in providing information to sponsors and vendors during study startup, conduct and closeout process.
  
• Ensures the study site operates at RCA expected levels of service, timeliness, and accuracy.\
• Supervises clinical research staff by setting goals, conducting regular meetings, and monitoring performances.
• Assists the Clinical Trials Manager with study staff hiring, training, and annual evaluations.
• Updates site study assignment log and trial master file in Google Drive.
• Manages site protocol deviation tracking and ensures corrective action plans are implemented.
• Evaluate team environment and implement team building activities.
• Facilitates visits from sponsors, CROs, RCA and other stakeholders.
• Initiates and oversees study site purchase order process for supplies and devices.
• Provides weekly reports to the Clinical Trial Manager.
• Participates in meetings with other supervisors and attends RCA annual National meetings and required training.

Requirements

• Strong critical thinking and leadership skills
• Clinical Research Coordinator experience preferred
• High School diploma or the equivalent
• At least 2 years of clinical research coordinator experience or CRCC Certification/CCRP Certification
• This position requires a valid California driver’s license, a reliable vehicle, and current auto insurance.

Physical Requirements

• Must be able to stand for long periods of time
• Must be able to write
• Must be able to hold arms at shoulder height
• Must be able to communicate via telephone
• Must have manual dexterity to work with ophthalmic equipment

Summary

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