Clinical Trial Associate (CTA) - Now Hiring
Beacon Hill Life Sciences Boston
Waltham, MA
cta
team
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cta
tracking
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clinical operations
operations
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management
tmf
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December 3, 2022
Beacon Hill Life Sciences Boston
Waltham, MA
FULL_TIME, PART_TIME
Job Description
Job Description:
The Clinical Trial Associate (CTA) is a critical member of the project team. The CTA assists the Clinical Operations Team with all aspects in the administration relating to clinical trial conduct according to International Conference of Harmonization (ICH), Good Clinical Practice (GCP), Code of Federal Regulations (CFR) and company Standard Operating Procedures (SOP). The CTA assist the Clinical Operations Team with the management of clinical studies from study implementation (start-up) to study close-out.
Some or all of the responsibilities may be delegated to a Contract Research Organization (CRO)..
Primary Responsibilities
- Maintaining the Trial Master File (TMF) and assisting with site management, initiating the distribution, collection, handling, reviewing, tracking and archiving of essential documents throughout the lifecycle of clinical studies; this includes managing the filing indexes and maintaining current lists of correspondence; ensures completeness of, conducts regular audits of, organizes and archives clinical Trial Master File documents, including clinical study site documents, email correspondence, training materials and other study documents; participates in TMF or study audits as request and assists with responding to findings.
- Assists the study teams with site communications for various purposes – this includes feasibility/site identification activities and site updates
- Performs study start-up activities which includes but is not limited to review of informed consents, development and review of study reference plans and manuals; distribute, collect and conduct quality review of clinical study site documents
- Responsible for the submission of study documents to ethics committee and/or competent authorities; works as a liaison with review boards and independent ethics committees in the regulatory approval process.
- Assists with the creation and maintenance of study-specific documents, tools and materials and the procurement of study supplies.
- Provides study materials and supplies to the study sites and Clinical Research Associates (CRAs).
- Assists with tracking of clinical study progress including the creation and maintenance of study related trackers and status reports
- Participates in clinical team meetings – coordinates teleconferences / webinar and assists with the preparation of agendas, minutes and tracking of action items
- Prepares for and attends Investigator Meetings, as required. May participate in clinical vendor selection process, as required.
- Performs review of clinical data listings, as required
- Under general supervision, manage third party vendors in the every-day conduct of a clinical trial (central lab, reading center, IRB)
- May act as mentor and train less experienced CTAs.
- Maintains completion of company and study-specific trainings such as SOPs, policies, study plans and documents by due date
- May participate and contribute to the implementation of process improvements to support study teams, department or the company (e.g. SOPs)
- Assist with other duties and projects, as needed
Education & Experience:
- Undergraduate degree or its international equivalent in clinical, science or health-related field with a minimum of 2 years' clinical research experience with a pharmaceutical, biotechnology, or contract research organization (CRO).
Knowledge, Skills & Abilities:
- Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form.
- Demonstrate high ethical standards for honesty, truthfulness and integrity.
- Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines, as well as basic understanding of the phases of clinical drug development and clinical operation processes.
- Ability to receive general instructions on all new assignments and perform routine work with minimal or no supervision.
- Strong sense of urgency, organizational skills with attention to detail and ability to follow through on assigned tasks.
- Proficiency in computer literacy in several software packages, especially Microsoft Office applications (Word, Excel) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods.
- Enthusiastic team player and ability to work effectively in a team/matrix environment
- Ability to handle multiple tasks and deliver assigned tasks with quality and within specified timelines
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