Job Description
Position Summary
Under supervision, coordinates daily activities and operations of clinical research studies. Responsible for screening and enrolling patients, monitoring protocol implementation, completing required forms and reporting results, and regulatory submissions. Conducts data collection activities and may prepare analytical reports on study results. Follows established clinical study standards and procedures to plan and conduct clinical research studies. Maintain open communication with team members to ensure proper study progress.
Key Responsibilities
Education:
Under supervision, coordinates daily activities and operations of clinical research studies. Responsible for screening and enrolling patients, monitoring protocol implementation, completing required forms and reporting results, and regulatory submissions. Conducts data collection activities and may prepare analytical reports on study results. Follows established clinical study standards and procedures to plan and conduct clinical research studies. Maintain open communication with team members to ensure proper study progress.
Key Responsibilities
- Consents and enrolls patients for research studies by providing detailed information on the Research Study to patients and families.
- Is responsible for understanding and adhering to all policies and procedures and responds to all inquiries.
- Obtains informed consent and enrolls patients in research studies. Reviews clinical information to identify patients meeting study inclusion criteria.
- Serves as liaison to the families/patients in the research studies, conducted at both on site and off-site locations, guiding and advising them throughout each phase of the study.
- Coordinates follow up visits as necessary. Acts as a resource to study participants, addressing any concerns they may have.
- Troubleshoots resolution of any issues that may arise throughout the study. Coordinates and prepares documentation needed for Institutional Review Board (IRB) on submissions, for PI approval.
- Tracks progress from submission to approval. Assist in developing supportive study documents such as informed consent forms, monitoring templates, study subject tracking tools, monitoring forms, study manuals, and training materials, as required for a study.
- Assist with the tracking and compilation of enrollment information. May assist with preparation of manuscripts and reports to be submitted to academic journals.
- May help train and orient newly hired study personnel. Coordinates activities with various departments to ensure correct testing/processing and sends clear instructions to each study.
- Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study.
Education:
- A bachelor's degree in a science field
- 0-1 years of relevant experience
Numbers & Facts
| Location | Boston, MA |
Skills
- Analysis Skillsunmatched
- Clinical Informationunmatched
- Clinical Practices/Protocolsunmatched
- Clinical Researchunmatched
- Clinical Trialunmatched
- Clinical Validationunmatched
- Communication Skillsunmatched
- Data Collectionunmatched
- Data Entryunmatched
- Documentationunmatched
- IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
- Identify Issuesunmatched
- Informed Consentunmatched
- Operationsunmatched
- Operations Researchunmatched
- Problem Solving Skillsunmatched
- Project Trackingunmatched
- Regulatory Reportsunmatched
- Regulatory Submissionsunmatched
- Reporting Skillsunmatched
- Research Skillsunmatched
- Support Documentationunmatched
- Testingunmatched
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