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Clinical Research Manager
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Full-time
- An ATEC Clinical Research Manager (CRM) supports the company’s Clinical Research initiatives by managing the clinical research operations and successful execution of clinical studies and data collection efforts in partnership with our clinical practice partners.
- The role collaborates closely with other members of the Clinical & Scientific Affairs department as well as product marketing and field representatives.
- Develops study documents, including: protocols – requiring an interest in and capacity to understand the study objectives, key variables, and logistical requirements; case report forms (CRFs) – requiring insights on flow and format of clinical data acquisition; participant consent forms and other regulatory documents – requiring knowledge of institutional review board (IRB) requirements and processes and good clinical practices (GCP)
- Supervises in-house and field-based Clinical Research Associates (monitors) in site selection, initiation, and close-out; oversees CRA’s performance in liaising with site personnel to obtain, prepare, submit, and track local IRB review, contracting processes, and training of site personnel on study procedures
- Collaborates with other research personnel to generate factual and accurate output from study data, including interim reports, conference abstracts, presentations, manuscripts, product/procedural training and collateral
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