Lead Clinical Trial Coord CEC TIMI Cardiovascular

Job Description - Lead Clinical Trial Coord CEC TIMI Cardiovascular (3309491)

This position reports directly to the Clinical Events Committee (CEC) the Assistant Project Manager / Senior Project Manager for assigned clinical study.

This position is responsible to provide expert leadership in the processing of potential endpoint events reported by the investigative sites for event adjudication by the TIMI CEC.

By virtue of their knowledge and experience, this individual is expected to provide guidance and mentorship to Clinical Trial Coordinators regarding department / trial operations, interact with senior level study management personnel and complete work in a resourceful, self-sufficient manner.

Responsibilities

• Review source documents submitted by investigative sites for potential endpoint events to ensure documents were uploaded to the correct event in the electronic adjudication system (EAS).
• Provide a hyperlink to MGB’s secure file transfer protocol (sFTP) to investigative site personnel for source document transfer if the EAS is unavailable, not being used for the trial, or site personnel do not have access.
• Maintain an Excel database to track events and event statuses for trials not utilizing electronic adjudication.
• Submit documents to the designated translation vendor for translation into English and enter the submission into the translation tracker as directed.
• Perform a quality review of translated documents to ensure PII has been completely redacted by the vendor. Notify the Sr.

Project Manager of redaction oversights. Track, and redact the information following trial-specific conventions.

Review translated source documents for potential treatment unblinding information and redact information if identified.

Track any findings following trial-specific conventions.

• Compile the event dossier consisting of submitted source documents and the patient profile report downloaded from the designated location provided by the pharmaceutical sponsor / sponsor vendor.
• Advance events through the adjudication workflow following trial-specific procedures. Guide more junior trial team members in the prioritizing and processing of clinical events.
• Submit events to the assigned Medical Reviewer (MR) and process any queries to the investigative sites following trial-specific procedures.

Collaborate with MR to resolve complex query issues.

• Utilize the adjudication system’s audit trails to identify changes made to events before and after adjudication.
• Create templates for Notes to Adjudicators for events requiring re-adjudication.
• Participate in system validation by performing user acceptance testing (UAT) pre-system go-live and for system changes for the trial’s duration.
• Assist in the training and orientation of new staff / trial-team members.
• Assist in the scheduling of CEC meetings using MS Teams.
• Use the Mass General Brigham values to govern decisions, actions and behaviors.
• Other duties as assigned.

Minimum Requirements

• Bachelor’s degree required.
• 2-3 years of relevant clinical trial experience.
• A combination of education and experience may be substituted for requirements.
• Proficiency in MS Office products (Outlook, Word, Excel, and PowerPoint) and familiarity with databases.
• Possess strong interpersonal skills to effectively communicate with cross functional teams including staff at all levels of the organization.
• Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds, and levels within and external to the organization.
• Strong problem solving and negotiation skills.
• Ability to effectively conduct meetings, both formal and informal.
• Requires minimal direction from leadership and possesses the ability to learn quickly.

BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and / or other status protected under law.

We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Primary Location

MA-Boston-BWH Longwood Medical Area

Work Locations

BWH Longwood Medical Area

75 Francis Street

Clinical

Organization

Brigham & Women's Hospital(BWH)

Schedule

Full-time

Standard Hours 40

Shift

Day Job

Employee Status

Regular

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