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Clinical Research Specialist
2 months ago
GENERAL SUMMARY/OVERVIEW STATEMENT:
The Rheumatology & Allergy Clinical Epidemiology Research Center (RACER) is a key component 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 governmental health 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 in clinical epidemiology, qualitative and survey research, implementation science, informatics, economics, and computer simulation modeling. Research efforts include extensive observational database studies and the enrollment of patients in cohort and clinical trial investigations, focusing primarily on conditions such as vasculitis and IgG4-related disease.
JOB DESCRIPTION:
- Collaborate with fellow research coordinators to facilitate clinical research operations within the department.
- In partnership with the Research Manager and/or Principal Investigator, develop and execute innovative research protocols, including study design, data collection frameworks, and securing institutional review board approvals.
- Engage in patient recruitment for clinical trials and registries, maintaining communication with participants before and throughout their involvement in the study, and ensuring informed consent is obtained.
- Formulate and implement strategies for effective patient recruitment.
- Screen potential participants for eligibility and facilitate the enrollment of qualified candidates.
- Conduct study visits and assessments.
- Work closely with the Principal Investigator and team members to ensure the successful execution of clinical studies and registries.
- Prepare protocol applications and maintain 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 necessary information.
- Oversee IRB applications and submissions.
- Manage financial aspects of studies, ensuring positive financial health, preparing invoices, tracking payments, and facilitating participant reimbursements as per study agreements.
Investigator Support:
- Coordinate meetings and schedules.
- Assist in manuscript and presentation preparation, including literature reviews, citation management, drafting, and creating tables and figures.
- Provide clinical operations support as required.
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 pertinent experience will be considered for more advanced roles.
- Familiarity with Good Clinical Practice, case report forms, laboratory procedures, safety protocols, and study execution is essential.
SKILLS:
- Ability to work autonomously.
- Strong interpersonal skills for effective interaction with study participants.
- Proficient oral and written communication abilities.
- Analytical skills with the capacity to address technical or research-related challenges and interpret data results.
- Understanding of clinical research protocols.
- High level of computer proficiency.
- Exceptional organizational skills with the ability to prioritize multiple tasks.
- Meticulous attention to detail.
- Demonstrated professionalism and respect for participants' rights and individual needs.
