Clinical Research Specialist

2 weeks ago

Boston, Massachusetts, United States Mass General Brigham Full time

GENERAL SUMMARY/OVERVIEW STATEMENT:

The Rheumatology & Allergy Clinical Epidemiology Research Center (RACER) is part of the Division of Rheumatology, Allergy and Immunology and the Mongan Institute at Mass General Brigham. This center comprises esteemed research faculty from Harvard Medical School who lead a significant portfolio of research funded by various organizations, including foundations, industry, and governmental agencies. The selected candidate will collaborate with a distinguished, multidisciplinary team from Mass General Brigham and Harvard Medical School, as well as partners from multiple institutions.

RACER employs a variety of methodologies, including clinical epidemiology, qualitative and survey research, implementation science, informatics, economics, and computer simulation modeling. The center's research encompasses large observational database studies and involves the enrollment of patients in cohort and clinical trial studies, focusing primarily on conditions such as vasculitis and IgG4-related disease.

JOB DESCRIPTION:

  • Collaborate with fellow research coordinators to support clinical research initiatives within the department.
  • In partnership with the Research Manager and/or Principal Investigator, develop and implement innovative research protocols, including study design, data collection systems, and securing institutional review board approval.
  • Engage in patient recruitment for clinical trials and registries, ensuring effective communication with participants before and throughout their involvement in the study.
  • Devise and implement strategies for patient recruitment.
  • Screen potential participants for eligibility and facilitate the enrollment of qualified candidates.
  • Conduct study visits and maintain close collaboration with the Principal Investigator and other team members in executing clinical studies and registries.
  • Prepare protocol applications and maintain regulatory documentation, including case report forms, source documents, and other essential study materials, while monitoring and reporting any clinical adverse events.
  • Ensure compliance with Hospital and Sponsor/NIH guidelines by maintaining and updating necessary information.
  • Manage IRB applications and submissions.
  • Oversee study finances, ensuring the financial health of studies, preparing invoices, tracking payments, and facilitating participant payments and reimbursements as needed.

Investigator Support:

  • Organize meetings and manage meeting schedules.
  • Assist in manuscript and presentation preparation, including literature reviews, citation management, drafting, basic data manipulation, and the creation of tables and figures.
  • Provide clinical operations support as required.

QUALIFICATIONS:

  • Bachelor's degree is required.
  • New graduates with relevant coursework or project experience, as well as candidates without prior research experience, may be considered for the Clinical Research Coordinator I position.
  • Candidates with 1-3 years of directly related experience will be considered for the Clinical Research Coordinator II position.
  • Familiarity with Good Clinical Practice, case report forms, laboratory processes, safety protocols, and study conduct is essential.

SKILLS:

  • Ability to work independently and demonstrate initiative.
  • Exceptional interpersonal skills for effective interaction with study participants.
  • Strong oral and written communication abilities.
  • Analytical skills to address technical or research challenges and interpret data results.
  • Knowledge of clinical research protocols.
  • High level of computer proficiency.
  • Excellent organizational skills with the ability to prioritize multiple tasks.
  • Meticulous attention to detail.
  • Professionalism and respect for participants' rights and individual needs.

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