Clinical Research Assistant

Job Description

Job Title:Clinical Research Assistant

Reports to: Site Director

Job Summary:

Under the direct supervision of the Investigator, Study Coordinator and other Site Staff as delegated the Employee will assist in the preparation and execution of daily tasks such as:

• Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Excell Research SOPs
• Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
• Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
• With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc.) within scope of the protocol, local law and regulations
• Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
• Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
• Answer the phone and screen incoming calls from prospective research subjects who are interested in participating in Clinical Research
• Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.
• Submit requests for Release of Records on subjects (Medical & Pharmacy)
• Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator
• Prepare source document charts, copy and/or file medical records and study related documents as required.
• Assist with regulatory tasks as assigned by study team
• Other duties as assigned
• After training, there is growth opportunity to transition to Clinical Research Coordinator position, see below for more information

Minimum Requirements:

• Excellent oral, written and listening communication skills
• Analytical, administrative and organizational skills
• Demonstrate working knowledge, skill and experience utilizing MS Word, Excell, Access and Power Point
• Ability to reliably commute to Oceanside, CA 92056 (in-office required)

Education and Experience:

• High School Graduate and/or technical degree with minimum of 1 year of relevant experience in Health care (Required)
• Bachelor’s Degree in Psychology, Biology, Science and Medicine (Preferred)
• Clinical Research: 1 year (Preferred)
• Work Experience: 1 year (Required)

Working Hours:

Full-Time Position

Monday-Thursday: 8:30 AM - 6:00 PM PST with potential for occasional travel for work outside of office hours

Compensation: Compensation: $20 - $22 per hour depending on experience; with possible salary adjustment after 3 months of employment

Growth Opportunity:

After training completion for Clinical Research Assistant, the Employee could transition to Clinical Research Coordinator.

Job Summary:

Assume responsibility for 4 or more ongoing clinical trials; inclusive-but not limited to the following:

• Attendance of Investigator Meeting
• Preparation/Completion of Source Documents
• Obtain Vital Signs and perform Electrocardiogram and Central Laboratory Assessments with appropriate training
• Perform Study Drug Accountability and Dispensation
• Ensure familiarity with all Study Protocols
• Ensure Subject Compliance with Study Protocols
• Complete Data Entry
• Oversee Monitoring Visits to ensure compliance with GCP standards
• Other duties assigned

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Job Type: Full-time

Pay: From $20.00 per hour

Expected hours: 36 per week

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• Day shift

Education:

• High school or equivalent (Required)

Experience:

• Clinical Research: 1 year (Preferred)
• work: 1 year (Required)

Ability to Relocate:

• Oceanside, CA 92056: Relocate before starting work (Required)

Work Location: In person