Clinical Research Specialist Job in Boston 02115, Massachusetts US
Summary: The Clinical Trials Specialist (CTS) performs, coordinates, and monitors all aspects of the regulatory process within clinical trials in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols.
Conducts site visits to determine protocol and regulatory compliance, and prepares required documentation.
Responsible for multiple projects and must work both independently and in a team environment.
May participate in protocol and study development and start up processes including reviewing protocols, designing and/or reviewing Case Report Forms, preparing informed consent documents, developing study specific source document worksheets, and working with study team management on operational strategies.
Primary Duties and Responsibilities: - Assist in the development and writing of clinical trial protocols.
- Liaise with investigators and disease groups on conducting clinical trials.
- Prepare and manage regulatory applications to federal and local agencies (FDA, OHRS, etc.) and the related approval process.
- Locate and/or assess the suitability of study sites to conduct clinical trials.
- Monitor trial progress throughout its duration which may include visiting study sites on a regular basis.
- Verify that data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification).
- Act as a regulatory resource for study sites by maintaining regular contact with investigators and study teams during the course of studies to ensure that compliance is maintained.
- Prepare reports as required regarding the status of ongoing studies and make necessary recommendations for contingency planning.
Requires excellent verbal and written communication skills with an in-depth knowledge of GCP guidelines, medical terminology, and the clinical trial process.
In addition, excellent interpersonal skills with strong organizational skills and an attention to detail are needed.
Must be computer literate and be able to travel depending on project needs.
Requirements: BS/BA degree required; Master's preferred.
Minimum of 5 years clinical research experience with oncology background preferred.
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