ClinDatrix is looking to hire full-time regional CRA employees for the following regions: East Coast and Mid-West. ClinDatrix is a small service provider, CRO, located in Irvine, CA dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries.
- Responsibilities primarily involve the management of assigned investigational study sites including prestudy, initiation, monitoring, and study close-out site visits.
- Generate, revise, circulate and/or track project-specific documentation as needed including but not limited to the protocol, case report forms, and completion guidelines, informed consent forms, and regulatory packets.
- Contribute to the maintenance of Trial Master File and electronic project organization and documentation system.
- Maintain contact with study sites, sponsors, and other involved parties to ensure good communication and progress of the project.
- Organize and/or participate in training exercises as needed to remain as current as possible in related areas.
- Assist with writing, revising, and participate in training and presentations of industry Standard Operating Procedures
Qualification and Requirements
- Bachelor’s degree or the equivalent in a scientific discipline
- Three or more years of work experience with clinical site monitoring experience
- Knowledge of Good Clinical Practices (GCP), clinical monitoring, study site oversight and management, and regulatory compliance
- Excellent accuracy and attentiveness to detail
- Strong written and verbal communication skills; strong interpersonal skills
- Good organizational skills with the ability to multitask and prioritize workload
- Good computer skills (Word, Excel, Email)
- Effectively work independently as well as within a team matrix
- Willing and able to travel
- Ability to handle stressful situations and deadlines
Job Type: Full-time
Salary: $85,000.00 to $110,000.00 /year
- Does your resume specifically list a "Clinical Research Associate" position that you have held?
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off