The Clinical Research Coordinator II (CRCII) will work in the Manstein Lab at the Cutaneous Biology Research Center and will be responsible for coordinating one or more human clinical studies. The Manstein Lab focuses primarily on the development of medical devices for applications in human skin and other organs. The CRCII will support a team of clinicians, clinical fellows and biomedical engineers in conducting clinical trials of new and/or improved medical devices. The CRCII will be responsible for efficient submission of clinical protocols to the IRB, coordinating responses to IRB feedback, coordinating conduct of the clinical study, management and storage of study data, ensuring QA/QC procedures are followed appropriately, supporting annual review submissions to the IRB, and supporting the team in developing study reports, journal publications and other documents describing the conduct and results of the study.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The Clinical Research Coordinator II works independently and under minimal supervision. Major duties include: assisting with recruiting patients for clinical trials; collecting and organizing patient data; maintaining records and databases; using software programs to generate graphs and reports; obtaining patient study data from medical records, physicians, etc.; conducting library searches; performing administrative support duties as required; verifying accuracy of study forms; updating study forms per protocol; preparing data for analysis and data entry; assisting with formal audits of data; documenting patient visits and procedures; assisting with regulatory binders and QA/QC procedures; assisting with interviewing study subjects; administering, scoring and evaluating study questionnaires; providing basic explanation of study and, in some cases, obtaining informed consent from subjects; performing simple study procedures; assisting with study regulatory submissions; writing consent forms; verifying subject inclusion/exclusion criteria; maintaining research data, patient files, regulatory binders and study databases; performing data analysis and QA/QC data checks; organizing and interpreting data; developing and implementing recruitment strategies; acting as study resource for patient and family; monitoring and evaluating lab and procedure data; may contribute to protocol recommendations; assisting with preparation for annual review; may assist PI to prepare complete study reports.

Qualifications
SKILLS/ABILITIES/COMPETENCIES REQUIRED:

Skills and competencies required of the Clinical Research Coordinator II include:

• 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
• Ability to work independently and as a team member
• High degree of computer literacy
• Analytical skills and ability to resolve technical problems
• Ability to interpret acceptability of data results
• Working knowledge of data management program

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable):

Current CITI Certification required

EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.Partner's Healthcare is acting as an Employment Agency in relation to this vacancy.

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