Clinical Research Associate Senior

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Job Summary

The Multicenter Program within the MGB Cancer Institute Clinical Trials Office is seeking candidates experienced in clinical trial coordination and implementation to support multicenter coordination and monitoring of investigator-initiated oncology clinical trials. The Multicenter Program is an internal clinical trial operations team specializing in the central coordination monitoring and regulatory oversight of MGBCI investigator-initiated clinical trials that are expanded to participating sites outside of the Harvard Cancer Consortium.


The Multicenter Senior Clinical Research Associate/Monitor (Sr. CRA) coordinates a portfolio of investigator-initiated multicenter clinical trials with limited project management support. The Sr. CRA oversees site activation training monitoring and ongoing compliance while ensuring all regulatory requirements are met. This centralized trial coordination role does not involve direct patient contact.


Principal responsibilities include:


Trial and portfolio coordination

Provide comprehensive trial coordination from pre-activation to study closure; ensure timely and efficient protocol initiation execution and completion.

Coordinate track and streamline key milestone achievements and overall progress of the trial across all participating sites:

o Document seminal events from pre-activation to closure; use program templates and tools to organize cumulative data and cyclic events such as enrollment reportable events continuing review safety reporting etc.

o Direct site onboarding and activation and maintain continuous oversight of study site activity

o Devise and implement strategies to ensure operational and protocol compliance

o Establish and track centralized procedures such as investigational drug shipment and biospecimens collection and processing .

o Anticipate manage and prepare work products and deliverables within appropriate due dates and deadlines

Maintain and amend protocol documents as applies; ensure version control across sites

Act as central communications liaison for all clinical trial collaborators

Routinely update the Sponsor-Investigator of trial progress and any concerns with site performance

Provide updates and new information to participating sites in a timely fashion

Facilitate routine multicenter teleconferences and meetings

Assemble study progress and safety reports for review boards and stakeholders

Effectively troubleshoot questions or setbacks regarding trial progress as they arise


Site Monitoring and Training

Verify patient eligibility via source document review and clinical analysis of case data

Collect and interpret data necessary for enrollment; register patients appropriately

Monitor and evaluate protocol and data compliance

Conduct routine monitoring visits and close-out visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring visits)

Perform source document verification and drug accountability

Review study sites regulatory binders and essential regulatory documents for completeness and accuracy

Facilitate site initiation visits and amendment training

Prepare and update training materials


Regulatory responsibilities

Ensure Federal and local Sponsor-Investigator regulatory responsibilities are met

Maintain electronic Trial Master File and Site Specific Files

IND management; compose and submit FDA investigator amendments protocol amendments safety reports annual progress reports etc.

Provide reportable events to regulatory entities and stakeholders on behalf of participating sites


Program responsibilities

Train and orient new/junior staff; provide leadership and guidance within and across program teams

Negotiate increasingly complex clinical trial attributes

Assimilate and report study metrics and timelines to program management

Contribute to continuous quality assurance initiatives within the program


Skills/Abilities/Competencies Required


Ability to independently and effectively coordinate a portfolio of clinical trials

Exceptional time management skills with the capacity to prioritize among multiple tasks

Excellent written and verbal communication skills

Ability to interpret acceptability of data results and identify incorrect or incongruent data

Able to work successfully in a remote environment and demonstrate initiative and accountability

Motivated to help team achieve results and meet deadlines

Problem-solving skills including the ability to gather information identify resources and develop alternatives

Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP)

Education
Bachelors Degree required


Experience
2-4 years related experience required

Knowledge Skills and Abilities
- Excellent written and verbal communication skills.
- Knowledge of current and developing clinical research trends.
- Sound interpersonal skills and the ability to mentor others.
- Ability to work independently and display initiative.
- Ability to identify problems and develop solutions.
- Demonstrated ability to successfully manage multiple projects.
- Established rapport with investigators and sponsors with the ability to resolve operational matters within a disease group.

Remote

101 Merrimac Street

40

Regular

Day (United States of America)

Pay Range

$50502.40 - $82014.40/Annual

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.

0100 Mass General Brigham Incorporated 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 .