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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:

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.

 

KNOWLEDGE, SKILLS & ABILITIES (KSA’s):

• 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.

 

DUTIES, RESPONSIBILITIES & EXPECTATIONS:

• 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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