JOB DESCRIPTION

We are looking for candidates with at least 2+ years of clinical research experience as a Clinical Research Coordinator.

Medical background and excellent interpersonal skills are a plus.

The Clinical Research Coordinator (CRC) is responsible for coordinating and administering clinical trials under the direction of the Clinical Research Manager, the Principal Investigator, and the Medical Director. The CRC will develop, implement, and coordinate research and administrative procedures to successfully manage clinical trials between Phase I thru Phase IV. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high knowledge of study-specific protocols.

Responsibilities:

• Overseeing the smooth running of clinical trials between Sponsors and sites.
• Interfaces with research participants and resolves issues related to study protocols.
• Promote patient retention in long-term clinical trials.
• Periodically reviews operations, including laboratory procedures to ensure compliance with applicable regulations.
• Responsible for reporting promptly SAEs, Protocol Deviations and responding to requests and questions from the regulatory department for prompt IRB Submissions
• Interfaces with study sponsors, monitors, and resolves study queries.
• Collecting, coding, and documenting data obtained from research.
• Informing participants about study objectives.
• Monitoring research participants to ensure adherence to study rules.
• Adhering to research regulatory standards.
• Adhering to ethical standards.
• Maintaining detailed records of studies as per FDA guidelines, including things such as drug dispensation.
• Liaising with laboratories regarding findings.
• Participating in subject recruitment efforts.
• They are ensuring that the necessary supplies and equipment for a study are in stock and working order.
• Engaging with subjects and understanding their concerns.
• Ensure that non-serious and serious adverse events are properly documented and reported
• Screen all laboratory results when received and follow protocol procedure regarding abnormal results
• Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder
• Submit patient reimbursement requests after the patient participates in the protocol
• Ensure the filing and maintenance of all regulatory documents
• Collect, process, and ship blood/urine specimens at scheduled patient visits
• Perform study procedures such as a collection of patient vitals,ECGs,medical history, comments etc.Schedule all patient research visits and procedures consistent with the protocol requirements
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
• Administer questionnaires/diaries per protocol
• Other duties as assigned.

Qualifications

• Bachelor’s Degree
• At least 2+ years experience as a CRC in Phase 1 studies preferred or 5+ years experience in a research setting, university, or hospital environment, familiarity with research methodologies required.
• Advanced degree, MA, PhD, MD and experience in research administration and grant design preferred.

Benefits:

• 401K
• Medical Insurance
• Life Insurance ($10,000) applicable after 90 days with the company
• Mileage is reimbursed when travelling from one site to another.
• Paid sick days
• Remote work 1 day/week

The company does not offer relocation expense package.

Application process:

-Provide at least 2 references from a previous/and/or current supervisor in your Resume/CV.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Oxnard, CA 93030: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• as a CRC in Phase 1 studies: 2 years (Required)
• in a research setting, university, or hospital environment: 5 years (Preferred)

Language:

• Spanish (Preferred)
• English (Preferred)

Work Location: In person

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.