Clinical Research Associate jobs in Bakersfield, CA

Description

RESPONSIBILITIES:

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Assists PI in communication of study requirements to all individuals involved in the study.
• Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Will screen or assist with screening subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Coordinates participant tests and procedures.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Completes study documentation and maintains study files in accordance with sponsor requirements and CBCC Research Global policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Retains all study records in accordance with sponsor requirements and institutional policies and procedures.
• Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
• Other duties a Clinical Research Coordinator may have include serving as a liaison with other departments, maintaining regular communication with the sponsor, or IRB, assisting the investigator with budgeting and contracts, problem-solving, coordinating sponsor or regulatory audits, recruiting new studies, and professionally representing the site to all in the best possible light.

Job Type: Full-time

Requirements

EDUCATION & EXPERIENCE:

• Degree in biology, research, or related field OR
• Minimum 1 - 2 years of experience in research with a pharmaceutical, biotech, or research company or experience in a clinical setting such as medical assistant (oncology preferred).
• ACRP or SoCRA certification (not required but preferred)

REQUIREMENTS:

• Must be able to work a full-time flexible schedule
• Must be able to pass all pre-employment screening (background check, drug tests, and references)
• To comply with organizational behavioral standards
• Must attend basic orientations prior to independently working in scheduling
• Must be able to pass all program mandated health screenings

SKILLS:

• Medical terminology and Patient care (Oncology preferable but not a mandate)
• Demonstrated analytical and problem solving abilities, including skills in making recommendations and decisions.
• Communication skills, Interpersonal skills, flexibility, and customer service orientation.
• Computer skills, to include data entry, word processing, and spreadsheets
• Organize resources and establish priorities.
• Collecting, verifying, and correcting research data.
• May provide technical guidance to a variety of individuals.
• Provide accurate and timely records
• Solicit sensitive information from patients and other responsible parties
• Remain calm with patients and other parties under stressful conditions
• Must be able to work in a team environment as part of a research team.

PHYSICAL STANDARDS:

Positions in this class are situated in a standard office environment where there is little or no exposure to variations in the weather or other similar elements. Physical agility must be such that the Clinical Research Coordinator is able to sit, walk, crouch, lift, and utilize phones for extended periods of time while utilizing their hands, wrists, legs, and arms. This position utilizes office machines (e.g., computers, adding machines, printers, copiers, scanners, etc.) and requires sufficient manual dexterity to operate them all. The Clinical Research Coordinator should be able to lift up to 20 pounds repeatedly and 45 pounds intermittently