BFT Clinical Research Coordinator

• 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