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)
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.