Senior Clinical Trial Associate

Description

At Viridian, we work with a sense of urgency for patients, creating unity with our team, the industry, and the community. We are committed to using proven science and engineering to improve the lives of people living with serious and rare diseases and we are getting closer to achieving this goal every day.

Reporting to the Clinical Trials Manager, the Sr. Clinical Trials Associate/CTA will assist 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 assists the Clinical Operations Team with the management of clinical studies from study implementation (start-up) to study close-out.

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Maintain the Trial Master File (TMF) and assist with site management, initiate the distribution, collection, handling, review, track and archival 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 include but are 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 or tracking the submission of study documents to ethics committee and/or competent authorities; works as a liaison with Contract Research Organization (CRO) and/or 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 the CRO study team as necessary.
• 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 everyday conduct of a clinical trial (e.g. central lab, reading center, IRB)
• May act as mentor and train less experienced CTAs
• Maintains completion of company and study-specific training such as SOPs, policies, study plans and documents by due date
• May participate in 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

Requirements

• 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)
• Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and writing
• Demonstrated 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 mu