Clinical Research Associate
Van Nuys, CA, US
Scientific
Bachelors Degree
Full Time, Temp to Hire
$80-100,000/Year (commensurate with experience)
Experienced (Non-Manager)
Remote
Biotechnology/Pharmaceuticals
First Shift (Day)
Van Nuys, CA, US
$80-100,000/Year (commensurate with experience)
Experienced (Non-Manager)
Full Time, Temp to Hire
Biotechnology/Pharmaceuticals
Remote
Scientific
Bachelors Degree
First Shift (Day)
Job details
- Location: Remote – Home based
- Opportunity: 3–6-month full time contract with potential to extend or convert to direct hire with our CRO client
- Salary depends on location and years of experience: Range target is $35.00-45.00 w-2 hourly
The Clinical Research Associate will ensure clinical trials are completed on-time, according to the protocol, and to keep clients and sites informed throughout the process.
Responsibilities
- Manage diagnostic clinical studies
- Develop and manage the protocol, case report form, budget/contract negotiation and regulatory document management
- Assist clinical sites with IRB submission/documentation, as needed
- Setup and keep Diagnostica, their own remote clinical trial management system, up to date
- Monitor clinical studies.
- Develop monitoring plans, identify issues, and resolve queries, ensure site regulatory binders are compliant
- Manage site relationships by helping with study startup, answer questions during the study, ensure timely payments and close out activities
- Ability to travel Nationwide depending on the study load and expectations (10-50% expectations)
- A minimum of 4 years’ experience in the clinical research industry supporting clinical studies or clinical operations currently or recently
- Prefer at least 1-2 years clinical research monitoring experience
- Must have strong understanding of clinical trial regulatory and compliance processes
- Understanding of regulations for FDA and Sponsor trial auditing
- Strong ability to research data and identify issues or potential red flags in a study
- Ability to learn quickly and expand knowledge into trial processes
- Diagnostic clinical study experience or lab diagnostic experience preferred
- Knowledge of accepted good clinical research practice (GCP) and procedures
- Excellent organizational, time management, budget management, and problem-solving skills
- Hustle: Comfortable in a fast-paced small company environment
- SOCRA CRA certification or will help you apply if not certified already once hired and through training
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