Clinical Research Coordinator Job at Retinal Consultants Medical Group
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, 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 150+ 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.
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 3 days per year.
After one year of service – 401K Plan Safe Harbor contribution (3% of annual earnings) received after 2022 plan year ends. Job Responsibilities 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 include, but are not limited to:
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. Required Skills and Qualifications Education: High School diploma or the equivalent
Experience / Knowledge / Skills:
RA III = 2 – 5 years or
Prior annual review or promotion assessment exceeds expectations and shows proficiency in the job requirements
Effective oral and written communication
Delivers safe and appropriate care to patients in addition to the requirements outlined by study protocols Certifications / Training:
ICH GCP Training / Certificate
IATA Certification Physical Requirements:
Sitting and viewing computer screen for extended periods
Keyboarding for extended periods
Standing or walking, up to 75% of the time
Lifting, reaching, and bending, often
Close visual acuity required to perform duties such as viewing computer monitor, and determining accuracy and thoroughness of work
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
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.
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 3 days per year.
After one year of service – 401K Plan Safe Harbor contribution (3% of annual earnings) received after 2022 plan year ends. Job Responsibilities 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 include, but are not limited to:
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. Required Skills and Qualifications Education: High School diploma or the equivalent
Experience / Knowledge / Skills:
RA III = 2 – 5 years or
Prior annual review or promotion assessment exceeds expectations and shows proficiency in the job requirements
Effective oral and written communication
Delivers safe and appropriate care to patients in addition to the requirements outlined by study protocols Certifications / Training:
ICH GCP Training / Certificate
IATA Certification Physical Requirements:
Sitting and viewing computer screen for extended periods
Keyboarding for extended periods
Standing or walking, up to 75% of the time
Lifting, reaching, and bending, often
Close visual acuity required to perform duties such as viewing computer monitor, and determining accuracy and thoroughness of work
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.