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Clinical Trials Coordinator

2 months ago

Boston, Massachusetts, United States Mass General Brigham Full time

GENERAL SUMMARY/ OVERVIEW STATEMENT :

The Clinical Research Coordinator II at Mass General Brigham plays a vital role within a collaborative team of healthcare professionals and support personnel dedicated to assisting researchers in the planning and execution of clinical studies. Key responsibilities encompass the submission and modification of Institutional Review Board (IRB) applications, coordination of services, and the development of order sets and flow sheets aligned with study protocols. The role also involves participant recruitment, appointment scheduling, and various delegated tasks as specified in the study-specific delegation log. Depending on individual experience and enthusiasm, there are opportunities to engage in the preparation and writing of scientific manuscripts. Candidates are expected to exhibit creative problem-solving skills, a readiness to acquire new competencies, and the capacity to manage multiple projects effectively. Familiarity with electronic health records and research scheduling platforms is advantageous. Previous research or relevant work experience is preferred.

PRINCIPAL DUTIES AND RESPONSIBILITIES :

The following functions represent the primary responsibilities typically associated with this position. Specific duties may vary based on departmental requirements, and not all responsibilities outlined will be assigned to every individual in this role.

  • Collect and organize patient data
  • Maintain comprehensive records and databases
  • Utilize software tools to create graphs and reports
  • Assist in recruiting participants for clinical trials
  • Gather patient study data from medical records and healthcare providers
  • Conduct literature searches
  • Ensure the accuracy of study documentation
  • Update study forms in accordance with protocols
  • Document patient visits and procedures
  • Support regulatory binder maintenance and quality assurance processes
  • Assist in interviewing study participants
  • Administer and evaluate questionnaires
  • Provide a basic overview of the study and, when necessary, obtain informed consent from participants
  • Execute study procedures, which may include blood draws
  • Aid in the preparation of study regulatory submissions
  • Draft consent forms
  • Verify participant eligibility criteria
  • Perform administrative support tasks as needed

A Clinical Research Coordinator II will also undertake the responsibilities of a Clinical Research Coordinator I and may additionally:

  • Manage research data, patient records, regulatory binders, and study databases
  • Conduct data analysis and quality assurance checks
  • Organize and interpret research data
  • Develop and implement participant recruitment strategies
  • Serve as a resource for patients and their families regarding the study
  • Monitor and evaluate laboratory and procedural data
  • Assess study questionnaires
  • Contribute to recommendations for study protocols
  • Assist in the preparation of annual reviews
  • Support the Principal Investigator in compiling comprehensive study reports

SKILLS/ABILITIES/COMPETENCIES REQUIRED :

  • Strong attention to detail
  • Excellent organizational capabilities
  • Ability to follow established protocols
  • Effective communication skills
  • Proficiency in computer applications
  • Familiarity with clinical research protocols
  • Demonstrated respect and professionalism for participants' rights and individual needs

The Clinical Research Coordinator II should also possess:

  • Ability to work autonomously and collaboratively within a team
  • Analytical skills and the capacity to troubleshoot technical issues
  • Ability to interpret the acceptability of data results
  • Working knowledge of data management systems

EDUCATION:

  • A Bachelor's degree is required.

EXPERIENCE:

  • Recent graduates with relevant coursework or project experience may be considered for the Clinical Research Coordinator I position.
  • Candidates with a minimum of 1-2 years of directly related experience will be considered for the Clinical Research Coordinator II position.

SUPERVISORY RESPONSIBILITY (if applicable):

  • A Clinical Research Coordinator I does not have supervisory responsibilities.
  • A Clinical Research Coordinator II may assist in training and orienting new staff members.