Clinical Trial Associate, Clinical Operations, Infectious Disease
1 month ago
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location: Telecommute
job type: Contract
salary: $ per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned clinical trial(s). This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including the electronic Trial Master File (eTMF). This position will work with internal team members and with external vendors and CROs. The position reports to the Clinical Operations Head in the assigned Therapeutic Area and will work cross-functionally and collaboratively to support clinical operations activities.
- Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines
- Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems
- Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3 rd party labs
- Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and access to company systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff)
- Coordinate Project Team and departmental meetings, including associated documentation
- Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase orders and invoices for assigned trials
- Develop and maintain strong, collaborative relationships with key stakeholders within the company, its CROs, and clinical sites
qualifications:- At least 2 years of experience in a clinical research environment
- Bachelor's degree in a science-based discipline preferred
- Basic understanding of drug development, including familiarity with FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Good verbal and written communication skills
- Good organizational skills and attention to detail
- Willingness to learn, able to take direction and ability to manage multiple tasks
- Self-motivated and comfortable with shifting priorities and change in a small company environment
skills: SOP, GCP (Good Clinical Practice), ICH Regulations, TMF
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.
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