BFT Clinical Research Coordinator

Site: The General Hospital Corporation

At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission—from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.

At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare — people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds – to apply.

Job Summary

Full-Time Clinical Research Coordinator II

Description

The Manstein Clinical Research Lab at the Cutaneous Biology Research Center is hiring a Full-Time Clinical Research Coordinator II to conduct and manage clinical trials and research studies related to dermatological conditions. The Manstein Lab focuses primarily on developing medical devices for applications in human skin and other organs. The CRCII will support a team of clinicians, clinical fellows, and biomedical engineers in clinical trials of new and/or improved medical devices. CRC II will coordinate the submission of clinical protocols to the IRB, coordinate responses to IRB feedback, coordinate conduct of the clinical study, manage and storage of study data, support annual review submissions to the IRB, and support the team in developing study reports. The CRC II will conduct regular assessments of participants and will help coordinate an online registry to monitor patient progress. The CRC will take part in other study activities in the unit, such as assisting with participant outreach, quality control, literature reviews, and manuscript preparation.

Qualifications

• Roles and Responsibilities
  
  

Must pay attention to detail

• Must enjoy working with people and be proactive to help engage hard-to-reach participants.
• Ability to quickly synthesize and manage data accurately from multiple sources.
• Self-starter with excellent communication, organizational, and analytical skills.
• Ability to work well as a team member and individually and to interface with individuals across a wide range of disciplines and experience.
• Ability to work well with technology and willingness to learn and work with new technology, such as Redcap.
• Study Planning and Initiation: The CRC assists in the planning and development of clinical research protocols and study design. They collaborate with the principal investigator (PI) and other stakeholders to define the study objectives, inclusion/exclusion criteria, and study procedures specific to dermatology research.
• Regulatory Compliance: The CRC ensures compliance with ethical and regulatory guidelines, such as obtaining necessary approvals from institutional review boards (IRBs) or ethics committees. They help prepare and submit the required documentation, such as informed consent forms and study protocols, to obtain regulatory approvals.
• Participant Recruitment and Screening: The CRC is responsible for identifying and recruiting eligible participants for the dermatology studies. They screen potential participants to assess their suitability based on inclusion/exclusion criteria. This involves conducting interviews, reviewing medical records, and performing dermatological assessments to determine eligibility.
• Data Collection and Management: The CRC oversees data collection activities, which may include taking measurements, documenting participant medical history, administering questionnaires, and capturing relevant data. They ensure accurate and timely data entry into electronic databases or case report forms (CRFs) and maintain data integrity throughout the study.
• Study Visits and Procedures: The CRC coordinates and conducts study visits, including performing dermatological assessments, measurements, and any necessary procedures. They ensure adherence to study protocols, maintain proper documentation of study visits, and handle adverse events or safety concerns that may arise during the course of the study.
• Collaboration and Communication: The CRC collaborates with other members of the research team, including investigators, research nurses, and laboratory personnel, to ensure smooth study operations. They facilitate effective communication among study staff, participants, and external parties, such as sponsors or contract research organizations (CROs).
• Study Monitoring and Quality Assurance: The CRC assists with study monitoring visits from sponsors, CROs, or regulatory authorities. They may help prepare for audits or inspections, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The CRC also participates in quality control and quality assurance activities to maintain data accuracy and integrity.
• Documentation and Reporting: The CRC maintains comprehensive and accurate study documentation, including source documents, regulatory files, and participant records. They assist in generating study reports, progress updates, and data summaries for the PI, sponsors, or regulatory authorities.
• Training and Education: The CRC may provide training and education to study staff, participants, or other stakeholders regarding study protocols, procedures, and regulations. They stay updated on dermatological research advancements, attend relevant educational sessions, and engage in continuous professional development.
  
  

Overall, the role of a clinical research coordinator in dermatology requires strong organizational skills, attention to detail, and a comprehensive understanding of research processes and regulatory requirements. They contribute significantly to the successful execution of dermatological research studies and the advancement of dermatology-related knowledge and treatments.

This is a full-time 40hr week in-person position, 8:30 am-5 pm, with some flexibility with the potential to be remote for some parts of the week in the future.

Qualifications

Education: Bachelor’s Degree Required

Experience

Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.

Supervisory Responsibility:

• A Clinical Research Coordinator II may assist with the training and orientation of new staff members.
  
  

Other:

Primary Location: USA-MA-Boston

Work Locations: MGH Main Campus, 50 Staniford Street, 2nd Floor, Curtis Center,

Boston, MA 02114, Charlestown Navy Yard

Job: Clinical Research Coordinator II

Organization: Massachusetts General Hospital (MGH)

Schedule: Full-Time

Standard Hours: 40

Shift: Day Job

Employee Status: Temporary

Recruiting Department: Manstein Lab

Additional Job Details (if Applicable)

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)
  
  

Remote Type

Onsite

Work Location

399 Revolution Drive

Scheduled Weekly Hours

0

Employee Type

Temporary

Work Shift

Day (United States of America)

EEO Statement:

The General Hospital Corporation is an Affirmative Action 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.

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.