Job Description
Clinical Research Associate
- Conducting pre-study, initiation, routine monitoring, and closeout visits
- Training study investigators and staff
- Preparing site visit reports
- Verifying data consistency
- Ensuring data collection timelines and deliverables
- Managing query resolution process
- Reporting protocol deviations
- Ensuring compliance with ICH/GCP/local regulations
- Developing and implementing corrective actions
- Tracking and reporting study progress
- Collecting, reviewing, and tracking essential documents
- Uploading documents into eTMF
- Planning and preparing training materials
- Managing Investigational Product (IP) inventory
- Ensuring proper collection and shipment of laboratory specimens
Qualifications:
- Bachelor’s Degree (BA/BS) in life sciences or nursing degree
- Minimum of five (5) or more years of relevant experience in clinical research or healthcare related industry, including a minimum of 2 years direct field monitoring experience, or equivalent combination of education and experience
- Independent site monitoring experience in all phases of clinical trials (phase 1, 2, and 3)
- Experience in oncology is highly preferred
- Experience/training in the following areas: GCP Regulations, ICH Guidelines, Good Quality Practices, 21CFR, HIPAA, Drug Development and Approval Process
- Proficiency with MS Office
- Excellent oral and written communication skills including presentation skills
- Ability and willingness to travel to investigational sites for on-site monitoring visits, up to 40% of the time.
- Ability to perform virtual monitoring remotely as needed
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Job Tags
Full time, Local area, Remote job,