Clinical Trial Associate

Job Description

Job Description

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

This position is site-based and requires a presence on-site three days per week in Bedford, MA.

Summary of Role

The Clinical Trial Associate (CTA), Clinical Operations is responsible for supporting the operational aspects of multiple studies across all stages of a trial (planning, start-up, execution, data analysis, reporting and closure). Responsibilities include generation of progress tracking reports, trial specific system set-up and access management, system data entry, meeting arrangement/minute capture, document management, and investigator meeting set-up and coordination. The CTA, as a key member of the study team is expected to provide the needed support to achieve operational deliverables.

Key Responsibilities / Essential Functions

• Participate in team meetings and prepare meeting agendas and minutes.
• Capture meeting action items and track activity status to closure.
• Develop, setup, and maintain study tracking tools for assigned trials to monitor study progress
• Prepare and maintain study progress data as appropriate (e.g., Key Performance Indicators), and prepare study progress reports as necessary
• Track study-related invoices and payments, and other financial information as needed
• Assist in the creation of study materials including study documents, site and patient facing materials, and presentations
• Contribute to the development and/or review of select study plans
• Distribute trial-related materials to sites and/or study team members
• Manage clinical study documents including reviews for completion, accuracy, and expiration
• Coordinate the collection and review of essential documents to authorize initial investigational product shipment and site activation
• Conduct periodic quality assessments of a vendor managed Trial Master File for outsourced studies
• Support the maintenance of the Trial Master File for sponsor-generated documents, and assist in quality assessments as appropriate
• Participate in CRF development and edit check testing
• Participate in user acceptance testing of study systems
• Participate in functional, cross-functional, and organizational initiatives
• Participate in CRO and clinical vendor oversight
• Perform other activities as assigned

Basic Qualifications

• Education: Bachelor’s degree in science or related field
• Minimum of 1-2 years experience in clinical research in industry (sponsor or CRO) is required.
• Preferred: CCRP training / certification

Other Requirements

• General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines and applicable regulatory regulations
• Advanced knowledge of clinical study processes
• Intermediate understanding of the Trial Master File reference model and the ability to navigate an eTMF (Veeva Clinical Vault experience preferred).
• Highly proficient in MS Office applications
• Well organized and detail oriented with strong written and verbal communication skills
• Effective time management and organizational skills
• Significant attention to detail
• Highly effective interpersonal skills

Core Values

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone’s health is in our hands
• Own the solution and make it happen

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at [email protected].