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Clinical Research Associate

Santa Monica, CA 90401

Posted: 01/12/2023 Job Number: z5G7h3l6a1kMvyS65NP3cyhlwaGC6MzxvQ5D9mfWxdM= Pay Rate: 51-N/A Hourly USD

Job Description

Job Title: - Clinical Research Associate

Job Location: - 1919 Santa Monica Blvd. Suite 400 Santa Monica, CA 90404

Job Duration: 6+ months (Possibility of extension)

Pay Rate: $51.00/Hr. on W2

Shift: Day 5x8-Hour (08:00 - 16:30)

Job Description:


The Clinical Research Associate II will assist the research department with case report form (CRF) completion for all clinical research protocols sponsored by various pharmaceutical and biotech companies.



• 2 years of experience in the field of clinical research

• Bachelor’s degree required, preferably in biology or science-related field

• 1 year of experience in a medical office is preferred

• Must have strong understanding of Good Clinical Practice in Clinical Trials, scientific principals, and clinical trial design

• Experience interacting with patients and/or families, pharmaceutical company representatives and other project personnel.

• Must demonstrate excellent communications skills, both written and verbal

• Ability to multi-task and manage time efficiently

• Ability to respond to common inquiries or complaints from patients, team members, pharmacy sponsors, or regulatory agencies.

• Able to work carefully and efficiently under stressful and or high demand situations

• Strong knowledge of GCP and ICH guidelines & local regulatory requirements

• Proficiency with EDC, CTMS and eTMF systems

• ACRP or SOCRA certification a plus, not required

• Candidates MUST be LOCAL to the job; no more than one hour commute away, preferably 1/2 hour commute.

• Must be fully COVID vaccinated INCLUDING Booster Shot.



• Reports and communicates to the sponsor/CRA/monitor/IRB.

• Coordinate data for completion of case report forms (CRFs), either paper or electronic data capture and perform data entry for clinical research trials and projects.

• Review all clinical study records to ensure complete documentation in compliance with regulations.

• Prepares charts for monitoring visits.

• Answers sponsor queries in a timely manner.

• Obtain physician signatures on CRFs and other study documentation as needed.

• Assists the research staff in meeting all data lock and query resolution deadlines.

• Updates outside sponsors as needed on query resolution, outstanding number of CRFs to be completed, etc.

• Provide support (including administrative/clerical) to staff and external sources related to current research projects.

• Attend meetings and telephone conferences related to research activities as needed.

• Act as liaison between research department and sponsor as needed to ensure timely CRF completion.

• Generate clinical SOPs, policies, charters, and plans according to US and international guidelines as applicable.

• Maintain research charts and subject records while prioritizing and maintaining progress on multiple scientific projects.

• Obtain medical records, death certificates and death information for all subjects as needed.

• Interact appropriately with other members of the clinical team and office personnel

• Advise supervisor, physicians, administrator of potential or actual problems; ie, report serious adverse events.

• May participate in CRF development for Investigator Initiated Trials

• May be involved in training and education of other CRAs.

• Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested.

• Review and adhere to department policies and procedures to maintain proficiency in operating guidelines.

• Maintain confidentiality when performing all duties and responsibilities.

• Demonstrate willingness to assist co-workers in completion of daily tasks or special projects to support the department’s efficiency.

• Will support finding creative solutions to complex scientific and business challenges.

• Maintain appropriate records, notification of time worked, vacations, seminars, and professional time commitments related to this position.

• Must show high energy with a focus in meeting deadlines

• Expected to focus on providing cutting edge technology that solves real business challenges and ultimately produces better treatment alternatives for patients.

• Expected to maintain customer focus in a way that ensures desired outcomes are achieved;

Perform other duties as assigned.
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