Mass General Brigham (Enterprise Services)
Clinical Research Associate I
Mass General Brigham (Enterprise Services), Boston, Massachusetts, us, 02298
Principal Duties and Responsibilities
Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
Enroll patients as required by the study sponsor and internal enrollment monitor team
Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
Maintain research charts and/or electronic files for all enrolled patients
Ensure adequate source documentation is in place for all data reported
Resolve data queries issued by the sponsor
Obtain protocol clarifications from the study sponsor and communicate information to the research team
Schedule and prepare for monitoring visits with sponsors
Organize and prepare for internal and external audits
Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
The following regulatory duties may be performed under general supervision by the Clinical Research Manager
Maintain and organize study specific regulatory binders
Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
Submit Data and Safety Monitoring Reports
Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
Collect, complete, and submit essential regulatory documents to various regulatory entities
Participate in monitoring visits and file all monitoring visit correspondence
Ensure appropriate documentation of delegation and training for all study staff members
Maintain screening and enrollment logs
Skills/Abilities/Competencies Required
Careful attention to detail
Good organizational skills
Ability to follow directions
Good communication skills
Computer literacy
Working knowledge of clinical research protocols
Ability to demonstrate respect and professionalism for subjects' rights and individual needs
Education Bachelor's Degree Related Field of Study required. Can this role accept experience in lieu of a degree? Yes.
Experience Research Related Experience 1-2 years preferred.
Knowledge, Skills and Abilities
Attention to detail.
Ability to recognize compliance and data integrity issues and respond appropriately.
Working knowledge of clinical research protocols.
Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
Effective interpersonal and communication skills.
Equal Opportunity Statement Mass General Brigham Incorporated is an Equal Opportunity 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.
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Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
Enroll patients as required by the study sponsor and internal enrollment monitor team
Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
Maintain research charts and/or electronic files for all enrolled patients
Ensure adequate source documentation is in place for all data reported
Resolve data queries issued by the sponsor
Obtain protocol clarifications from the study sponsor and communicate information to the research team
Schedule and prepare for monitoring visits with sponsors
Organize and prepare for internal and external audits
Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
The following regulatory duties may be performed under general supervision by the Clinical Research Manager
Maintain and organize study specific regulatory binders
Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
Submit Data and Safety Monitoring Reports
Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
Collect, complete, and submit essential regulatory documents to various regulatory entities
Participate in monitoring visits and file all monitoring visit correspondence
Ensure appropriate documentation of delegation and training for all study staff members
Maintain screening and enrollment logs
Skills/Abilities/Competencies Required
Careful attention to detail
Good organizational skills
Ability to follow directions
Good communication skills
Computer literacy
Working knowledge of clinical research protocols
Ability to demonstrate respect and professionalism for subjects' rights and individual needs
Education Bachelor's Degree Related Field of Study required. Can this role accept experience in lieu of a degree? Yes.
Experience Research Related Experience 1-2 years preferred.
Knowledge, Skills and Abilities
Attention to detail.
Ability to recognize compliance and data integrity issues and respond appropriately.
Working knowledge of clinical research protocols.
Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
Effective interpersonal and communication skills.
Equal Opportunity Statement Mass General Brigham Incorporated is an Equal Opportunity 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.
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