Clinical Trials Coordinator

2 weeks ago

Boston, Massachusetts, United States Mass General Brigham Full time

GENERAL SUMMARY/ OVERVIEW STATEMENT :

The Clinical Research Coordinator plays a vital role within a collaborative team of healthcare professionals and support personnel, assisting investigators in the planning and execution of clinical studies. Key responsibilities encompass IRB submissions and modifications, service applications, development of order sets and flow sheets aligned with study protocols, participant recruitment, appointment scheduling, and various delegated tasks as outlined in the study-specific delegation log. Depending on experience and enthusiasm, there are opportunities to engage in scientific manuscript preparation and writing. The ideal candidate will demonstrate creative problem-solving abilities, a commitment to learning new competencies, and the capacity to manage multiple projects simultaneously. 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 role. Specific duties may vary based on departmental requirements, and not all responsibilities will be assigned to every position:

  • 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 accuracy of study documentation
  • Update study forms in accordance with protocols
  • Document patient visits and procedures
  • Support regulatory binders and quality assurance/control processes
  • Aid in interviewing study participants
  • Administer and evaluate questionnaires
  • Provide basic explanations of the study and, when necessary, obtain informed consent from participants
  • Perform study-related procedures, which may include blood draws.
  • Assist with regulatory submissions related to the study
  • Draft consent forms
  • Verify participant eligibility criteria
  • Carry out administrative support tasks as needed

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

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

SKILLS/ABILITIES/COMPETENCIES REQUIRED :

  • Strong attention to detail
  • Excellent organizational abilities
  • Capacity to follow instructions accurately
  • Effective communication skills
  • Proficiency in computer applications
  • Understanding of clinical research protocols
  • Ability to demonstrate respect and professionalism towards 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 problem-solving capabilities
  • Competence in interpreting data results
  • Familiarity with data management software

EDUCATION:

  • A Bachelor's degree is required.

EXPERIENCE:

  • New graduates with relevant coursework or project experience, or those without prior research experience, will be considered for the Clinical Research Coordinator I position.
  • Candidates with a minimum of 1-2 years of directly related work 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.

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