Clinical Research Coordinator

6 days ago


Boston, Massachusetts, United States Mass General Brigham Full time
Job Summary

We are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at Mass General Brigham. The successful candidate will be responsible for supporting all aspects of clinical research coordination for studies at our Neurological Clinical Research Institute (NCRI).

Key Responsibilities
  • Coordinate all activities of subjects participating in individual research studies, including scheduling patients for research studies and collecting, organizing, and documenting patient data from visits.
  • Maintain accurate records and databases.
  • Assist with recruiting patients for clinical trials.
  • Obtain patient study data from medical records, physicians, and other sources.
  • Verify the accuracy of study forms and update them as necessary.
  • Prepare data for analysis and data entry.
  • Assist with regulatory binders and QA/QC procedures.
  • Administer and score questionnaires.
  • Provide basic explanations of studies and obtain informed consent from subjects, as needed.
  • Perform study procedures, such as phlebotomy, vital signs, and electrocardiogram.
  • Draft consent forms.
  • Correspond with the Institutional Review Board (IRB) for approval of protocols, notification of adverse events, continuation of studies, annual reporting of studies, and submission of amendments.
  • Assist professional staff with patient treatment according to study guidelines.
  • Know primary studies thoroughly to answer questions from study staff and patients.
  • Assure investigators receive results of tests, as appropriate.
  • Provide, create, and maintain record-keeping systems, including data collection forms, consent forms, side effect sheets, drug accountability and medication logs, initialization forms, and case report forms (CRFs).
  • Data entry of information into study databases.
  • Communicate with study sponsors, including scheduling and conducting monitoring visits.
  • Work cooperatively with study sponsors to ensure good clinical practices are followed.
  • Interact with internal and external stakeholders, including hospital departments and regulatory agencies.
Requirements
  • Bachelor's degree required.
  • Relevant coursework or project experience.
  • Understanding of federal regulations (FDA, CFR, etc.), IRB review process, informed consent, trial design, data monitoring, and good writing and editing skills.
  • Prior experience working in clinical research is a plus.
Working Conditions

Office work with occasional rotating shifts, travel, and exposure to dry ice and -80-degree freezers. May require lifting up to 20lbs and applying force to resist patients/subjects in hand-held dynamometry. May be exposed to bodily fluids, including blood, urine, and cerebral spinal fluid. May work at different Mass General Brigham sites.



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