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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.