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 will work cross-functionally and collaboratively to support clinical operations activities for a product's development.
Responsibilities:
Assist the Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with consistently high 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 3rd party labs/central labs
Collaborate with CRO/appropriate vendors to ensure timely training and access to necessary 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 organization, its CROs and vendors, and clinical sites
Qualifications:
BS in a science-based discipline preferred with 2 - 8+ years of experience in a clinical research environment
Basic understanding of drug development, including knowledge of ICH GCP guidelines to ensure the appropriate conduct of clinical studies
Self-motivated and comfortable with shifting priorities and change in a small company environment
Good verbal and written communication skills
Good time management skills
Excellent organizational skills and attention to detail
Willingness to learn, able to take (and apply) direction and ability to manage multiple, parallel tasks
Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply.
California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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Company Profile:
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com .
Benefits Information:
Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.