CEC Clinical Trial Coordinator

Site: The Brigham and Womens Hospital Inc.

Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Additional support for new studies

Job Summary

This position reports directly to the Clinical Events Committee (CEC) Assistant Project Manager/ Sr. Project Manager for assigned clinical trial(s). This position is responsible to process potential endpoint events reported by the investigative sites for event adjudication by the TIMI CEC.
This position assists with the day-to-day operational tasks of assigned CEC department trial.

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).
a hyperlink to MGBs 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.
and track events and event statuses for trials not utilizing electronic adjudication into an Excel database.
documents to the designated translation vendor for translation into English and enter the submission into the translation tracker as directed.
a quality review of translated documents to ensure PII has been completely redacted by the vendor. Notify the CEC Lead Coordinator or Sr. Project Manager of redaction oversights. Track and redact the information following trial-specific conventions.
translated source documents for potential treatment unblinding information and redact information if identified. Track any findings following trial-specific conventions.
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.
events through the adjudication workflow following trial-specific procedures.
events to the assigned Medical Reviewer (MR) and process any queries to the investigative sites following trial-specific procedures.
MR-approved events for adjudication at the scheduled CEC meeting. Process adjudicator queries for additional information following trial-specific conventions.
the adjudication systems audit trails to identify changes made to events before and after adjudication.
in system validation by performing user acceptance testing (UAT) pre-system go-live and for system changes for the trials duration.
assist in the training and orientation of new staff/trial-team members.
in the scheduling of CEC meetings using MS Teams.
the Mass General Brigham values to govern decisions actions and behaviors. These values guide how we get our work done: Patients Affordability Accountability & Service Commitment Decisiveness Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion Integrity & Respect Learning Continuous Improvement & Personal Growth Teamwork & Collaboration
duties as assigned

Bachelors degree preferred

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

Requires minimal direction from leadership and possesses the ability to learn quickly

Clinical/research office environment with extended hours as needed to meet project deadlines

Knowledge Skills and Abilities
- Excellent Organizational Skills.
- Solid written and verbal communication skills.
- Strong sense of accountability the ability to work autonomously.
- Ability to communicate effectively in a matrix environment.
- Ability to manage multiple tasks concurrently and to prioritize work appropriately.

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

Hybrid

350 Longwood Avenue

40

Regular

Day (United States of America)

Pay Range

$23.80 - $34.81/Hourly

Grade

6

At Mass General Brigham we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive and any offer extended will take into account your skills relevant experience if applicable education certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however it does not encompass all elements contributing to your total compensation addition to competitive base pay we offer comprehensive benefits career advancement opportunities differentials premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

The Brigham and Womens Hospital Inc. is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact Human Resources at .

Mass General Brigham Competency Framework