Clinical Trial Associate - Boston, United States - CEDENT

CEDENT

Verified Company

Boston, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

PURPOSE OF THE FUNCTION

As a member of the Clinical Trial Team (CTT), the Clinical Trial Associate Level 1 (CTA) will assist the Clinical Trial Managers (CTM) and other CTT functions with the conduct of assigned clinical trials, including administration, coordination, and archival tasks. Additionally, they will contribute to the inspection readiness of the electronic Trial Master File ([e]TMF), offer support in study-specific training, minute-taking, tracker creation/maintenance, and system access management for the CTT. Moreover, the CTA will aid the Global Head of Trial Operations and Vice President of Global Clinical Operations in organizing departmental meetings.

REPORTING LINE

Trial Operations Excellence Manager

ROLES AND RESPONSIBILITIES

Assist the CTM in coordinating logistical aspects of assigned trials in compliance with Good Clinical Practice (GCP) and relevant Procedural Documents.
Develop and tailor study documents to trial-specific requirements in collaboration with the CTM.
Organize trial-specific meetings, including trial team meetings and Investigator Meetings, by managing agendas, meeting minutes, and action items.
Ensure timely filing of (e)TMF documents in Electronic Clinical Operations system (ECO) by assessing completeness and quality, providing ECO usage support to the CTT.
Act as Business Administrator in ECO, overseeing record maintenance and closeout tasks, including archival preparation for study, country, and site records.
Assist the CTM in preparing Trial Operations (e)TMF documents for archiving.
Provide logistical assistance to the CTT regarding vendor (e)TMF oversight activities.
Support the Global Head of Trial Operations and Vice President of Global Clinical Operations in developing department templates and organizing departmental meetings efficiently.
Prepare and update trial reports for the CTT.
Collaborate with the CTM on advanced tasks such as reviewing vendor/sponsor plans and documents, coordinating trial insurances, reviewing submission packages, and participating in CTA/CTM interviews.
Support Clinical Development and Global Company initiatives as needed.

SKILLS AND COMPETENCIES

Fluent in spoken and written English.
Strong oral and written communication abilities.
Exhibits good cross-cultural sensitivity.
Excellent organizational skills with a knack for task prioritization.
Demonstrates the capacity to work independently and collaboratively within a multidisciplinary team.

EDUCATION, EXPERIENCE, AND QUALIFICATIONS

Bachelor's or University degree in medical, paramedical, or equivalent field through experience.
Minimum of 1 year of similar experience in Clinical Operations.
Proficient knowledge of International Conference on Harmonisation Good Clinical Practice (ICH-GCP).
Familiarity with Drug Information Association Trial Master File (DIA TMF) reference model.
Experience with at least one clinical trial management tool/system like Clinical Trial Management System, (e)TMF (Veeva Vault Clinical Operation), Electronic Case Report Form, or Interactive Response Technology system.

At Cedent, we are committed to fostering a warm and inclusive environment where all candidates are equally considered for employment, regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected characteristics. Cedent proudly upholds equal opportunity employment practices.