Job Description

Clinical Research Associate II page is loaded Clinical Research Associate II Apply remote type Remote locations Boston-MA time type Full time posted on Posted 8 Days Ago job requisition id RQ4022150 Site: Mass General Brigham Incorporated 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. Job Summary 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 Clinical Research Associate (CRA) candidates to assist with the coordination and monitoring of multiple oncology trials. The multi-center CRA works under general supervision to maintain regulatory files and monitor data quality and data and protocol compliance across participating study sites. The CRA will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of regulatory document coordination and tracking and clinical data review. This position does not include any direct patient contact. Qualifications Principle Duties & Responsibilities: The CRA will perform the following duties under general supervision by the Clinical Research Manager: · Track the progress of the trial across all participating sites (e.g., accrual, biospecimen collection and transfer, reportable events, regulatory submissions) · Correspond with participating sites to support trial activities as needed: o Answer questions about eligibility, study procedures or data entry o Prepare and distribute informational updates, including meeting minutes, missing data reports and safety reports o Communicate essential trial information and documentation, including protocol amendments; request routine updates from sites to maintain current study status o Facilitate database reviews and query resolution · Present the Sponsor-Investigator study status reports related to trial progress and assigned tasks · Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria · Conduct onsite and remote monitoring visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring o Perform source document verification and drug accountability o Review study site regulatory binder and essential documents for completeness and accuracy o Evaluate ongoing protocol and data compliance o Issue, track and resolve queries · Gather, track and organize essential regulatory documents from participating sites · Facilitate and document Sponsor-Investigator review of safety reports, investigational drug brochure updates, study violations and adverse events · Submits routine and expedited reports to the FDA, IRB, funding sponsor or other stakeholders. Skills/Abilities/Competencies Required · Careful attention to details · Superior organizational and time management skills and ability to prioritize multiple tasks · Problem-solving skills, including the ability to gather information, identify resources, and develop alternatives · Excellent written and oral communication skills · Able to work successfully in a fully remote environment · Demonstrate initiative and accountability · Ability and willingness to travel nationally. The Clinical Research Associate II should also possess: · Working knowledge of clinical research protocols · Ability to work independently with general supervision · Analytical skills and ability to identify and resolve problems and develop alternatives · Excellent judgment and ability to interpret information and protocol requirements Additional Job Details (if applicable) LICENSES, CERTIFICATIONS, and/or REGISTRATIONS: · None EDUCATION: · Bachelor’s degree required EXPERIENCE: · A minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Associate II position. SUPERVISORY RESPONSIBILITY: · A Clinical Research Associate II may assist with the training and orientation of new staff members 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. · Less than 25% domestic travel (1-2 field visits per month maximum) · Does not include patient contact Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) EEO Statement: 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 Veteran’s 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 (857)-282-7642. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline. Why work here? Combat disease. Hold a hand. Help people. Impact the world. Mass General Brigham is a passionate, welcoming community where minds meet caring hearts. Come be a part of the world’s most powerful force in medicine, where every role is important in changing lives. Are you ready? About Us? Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world. Built on the legacy of two leading academic medical centers, we’re more than a system—we’re leaders in the practice of medicine. Mass General Brigham is committed to serving the community. We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system. We recognize that increasing value and continuously improving quality are essential to maintaining excellence. #J-18808-Ljbffr

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