Clinical Research Coordinator- Parkcenter

Sacramento Native American Health Center, Inc; Sacramento (CA); On-site; USD 64,000 - 93,000; Full time

Benefits offered by this job

Paid Time Off

Holiday pay

Scrub Allowance

401k plan

Medical insurance with employer贡献

Job summary

Sacramento Native American Health Center, Inc. is seeking a full-time Clinical Research Coordinator to support ophthalmology trials focused on retinal diseases.

You will work with physicians, staff, and sponsors to plan, conduct, and monitor studies in a fast-paced clinical setting. Responsibilities include coordinating trial activities, maintaining source documents, screening participants, obtaining informed consent, and ensuring timely data entry and safety reporting in accordance with ICH-GCP

Qualifications

• Retinal photography experience preferred.
• High School diploma or equivalent.
• At least 2 years of clinical research experience or CRCC/CCRP certification.

Responsibilities

• Coordinate daily clinical trial activities and ensure protocol adherence.
• Manage study supplies, inventory, and lab kits.
• Train study staff on protocol and documentation.
• Recruit eligible participants and screen per criteria.
• Collect data and enter into the EDC system.
• Monitor adverse events and safety reporting.

Skills

Retinal photography experience

Education

High School diploma or the equivalent

2 years clinical research experience or CRCC/CCRP certification

Job description

• Base Pay $31.00 - $44.50 / Hour
• Employee Type Nonexempt FT

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 study
• Works with team member responsible for ordering study supplies (lab kits, shippers, etc.) to ensure adequate inventory is on hand
• Ensures study staff is properly trained on study-related information (i.e. protocol, ICF, manuals, etc.) and that the training is documented
• Creates, manages, and maintains source documents for each trial
• Attends teleconferences and Investigator Meetings as requested by research director
• Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections
• Works with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals
• Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility accurately
• Efficiently 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 study
• Assures that amended consent forms are appropriately implemented and signed
• Acts as a secondary reviewer to provide oversight so that the ICF process is conducted accurately
• Collects 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 timeframe
• Collects and reports ALL Adverse Events
• Collects and reports ALL Serious Adverse Events
• Responsible for ensuring all SUSAR/Safety Reports are acknowledged and reviewed
• Coordinates monitor site visits and assists with preparation of site visit documentation
• Works with the monitor to make any corrections needed to meet requirements and deadlines as needed
• Collects updated medical history, adverse events and serious adverse events that need to be reported to the sponsor and IRB within required timeframe
• Manages 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.

Requirements

• Retinal photography experience preferred
• High School diploma or the equivalent
• At least 2 years of clinical research experience or CRCC Certification/CCRP Certification

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.
• 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.