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 is led by esteemed Harvard Medical School Research Faculty and manages a diverse range of research initiatives funded by various organizations, including foundations, industry, and government agencies.

RACER employs advanced methodologies in clinical epidemiology, qualitative research, survey analysis, implementation science, informatics, economics, and computer simulation modeling. The research portfolio includes extensive observational database studies and clinical trials focusing on conditions such as vasculitis and IgG4-related diseases.

JOB DESCRIPTION:

  • Collaborate with fellow research coordinators to facilitate clinical research activities within the department.
  • In partnership with the Research Manager and Principal Investigator, design and implement new research protocols, including data collection systems and securing institutional review board approvals.
  • Engage in patient recruitment for clinical trials and registries, ensuring thorough interaction with participants throughout their involvement in the study.
  • Develop and execute strategies for effective patient recruitment.
  • Screen potential participants for eligibility and enroll qualified candidates.
  • Conduct study visits and assessments.
  • Work closely with the Principal Investigator and team members to execute clinical studies and registries efficiently.
  • Prepare protocol applications and maintain essential regulatory documentation, including case report forms and source documents, while monitoring and reporting any clinical adverse events.
  • Ensure compliance with hospital and sponsor/NIH guidelines by maintaining and updating study information as required.
  • Manage IRB applications and submissions.
  • Oversee study finances, ensuring positive financial health of research projects, preparing invoices, tracking payments, and facilitating participant reimbursements as necessary.

Investigator Support:

  • Organize meetings and coordinate schedules.
  • Assist in manuscript and presentation preparation, including literature reviews, citation management, drafting, and creating tables and figures.
  • Provide clinical operations support as needed.

QUALIFICATIONS:

  • Bachelor's degree is required.
  • New graduates with relevant coursework or project experience may be considered for entry-level positions.
  • Candidates with 1-3 years of relevant experience will be considered for more advanced roles.
  • Familiarity with Good Clinical Practice, CRFs, laboratory protocols, safety practices, and study conduct is essential.

SKILLS:

  • Ability to work autonomously.
  • Strong interpersonal skills for effective communication with study participants.
  • Proficient oral and written communication abilities.
  • Analytical mindset with problem-solving skills to interpret data results.
  • Knowledge of clinical research protocols.
  • High level of computer proficiency.
  • Exceptional organizational skills with the ability to prioritize multiple tasks.
  • Meticulous attention to detail.
  • Professional demeanor with respect for participants' rights and individual needs.


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