Clinical Trial Associate - Boston, United States - CEDENT

CEDENT

Verified Company

Boston, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

Job 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 if deemed necessary with the conduct of the assigned clinical trials, including the administration, coordination, and archival.

This person will also assist with the inspection readiness of the electronic Trial Master File ([e]TMF) and provide support with study specific training, minute taking, creation/maintaining of trackers, and system access management for the CTT.

In addition, the CTA will assist the Global Head of Trial Operations and Vice President of Global Clinical Operations with the logistics of the departmental meetings.

REPORTING LINE

Trial Operations Excellence Manager

ROLES AND RESPONSIBILITIES

Assist the CTM (and CTT if deemed necessary) with the coordination of the logístical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Procedural Documents.
Develop and adapt study documents to trial specific requirements in collaboration with the CTM.
Assist with organizing trial specific meetings (agenda, meeting minutes, and action item management), including but not limited to trial team meetings and Investigator Meetings.
Coordinate the filing of (e)TMF documents in the Electronic Clinical Operations system (ECO) by reviewing the completeness and document quality. Followup with the CTT on findings and provide support on how to use ECO correctly.
Act as Business Administrator in ECO, by maintaining records and supporting closeout activities (including archival preparation). This includes managing study records, country records, and site records.
Assist the CTM to ensure that the Trial Operations (e)TMF documents are made ready for archiving.
Provide logístical support to the CTT on vendor (e)TMF oversight activities.
Support the Global Head of Trial Operations and Vice President of Global Clinical Operations with the development of department template documents and the organization of the departmental meetings (agenda, meeting minutes, and action item management).
Prepare trial reports for the CTT and keep them uptodate.
Collaborate with the CTM on advanced tasks such as reviewing vendor/sponsor plans and documents, coordinating trial insurances, reviewing submission packages, and attending CTA/CTM interviews.
Support Clinical Development and Global Company initiatives as applicable.

SKILLS AND COMPETENCIES

Speaks and writes English fluently
Strong oral and written communication skills
Good crosscultural sensitivity
Excellent organization skills with the ability to prioritize tasks
Ability to work both independently and as part of a multidisciplinary team

EDUCATION, EXPERIENCE AND QUALIFICATIONS

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

At Cedent we strive to create a welcoming and inclusive environment.

Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

Cedent is proud to be an equal opportunity employer.