Clinical Research Associate Iii--Cancer Center Protocol Office

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking candidates experienced in clinical trial coordination and implementation to coordinate and monitor oncology trials.

The Multi-Center Clinical Research Associate/Monitor III (CRA III) works independently, under minimal supervision, to initiate, manage and navigate a portfolio of Investigator-initiated, multi-center clinical research trials. Specifically, the CRA III will carry out the activation, training, monitoring and oversight of participating institutions while also supporting and ensuring compliance with the regulatory responsibilities of the Sponsor Investigator. This role focuses on centralized trial coordination and does not include direct patient contact.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Principal responsibilities include:

Trial and portfolio coordination

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

• 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 procedures to ensure operational and protocol compliance

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

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

• Act as central communications liaison for all clinical trial collaborators

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

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

o Facilitate routine multi-center teleconferences and meetings

o Assemble study progress and safety reports for review boards and stakeholders

o Troubleshooting 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

o Collect and interpret data necessary for enrollment; register patients appropriately

• Monitor and evaluate protocol and data compliance

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

o Perform source document verification and drug accountability

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

• Facilitate site initiation visits and amendment training

o Prepare and update training materials

Regulatory responsibilities

• Ensure Federal and local Sponsor-Investigator regulatory responsibilities are met

o Maintain electronic Trial Master File and Site Specific Files

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

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

Program responsibilities

• Train and orient new/junior staff

• Assimilate and report study metrics and timelines to program management

• Contribute to continuous quality assurance initiatives within the program

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• 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:

• BA/BS degree required

EXPERIENCE:

• 2-4 years related experience required.

SUPERVISORY RESPONSIBILITY:

• Orients and trains new staff and may supervise staff in lower level positions

FISCAL RESPONSIBILITY:

• CRAs are responsible for conducting onsite monitoring visits in adherence to institutional travel policy and submitting expense documentation in a timely fashion.

WORKING CONDITIONS:

• Duties will mainly be performed in a remote setting; limited in-office presence anticipated. Applicants may work in all states with the following exceptions: WY, ND, Puerto Rico, and the U.S. Virgin Islands.

• Up to 25% domestic travel required (1-2 field visits per month)

• Does not include patient contact