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Clinical Research Manager

5 months ago

Carlsbad, United States Atec Spine 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. Specifically, the position is responsible for the management of research activities spanning from development of study documents, to site start-up and recruitment of study participants, collection and compilation of study data, assists with site data management and analysis oversight of site monitoring and reporting of site performance and adherence to protocols following Good Clinical Practices, and input toward the reporting of study results. In a team supervisory capacity, the CRM develops project budgets and operating procedures and documents, supervises in-house and field-based monitoring staff, and ensures that project milestones are met while managing adherence to approved budgets. The role collaborates closely with other members of the Clinical & Scientific Affairs department as well as product marketing and field representatives.

Essential Duties and Responsibilities

* 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
* Manages team toward the development of monitoring plans and procedures, the monitoring of site performance to study goals and adherence to study protocols, and the generation of monitoring reports to effectively communicate progress and/or issues to the site and internally to management
* Develops data collection and management plans, oversees this activity, and reports on study status
* Guides the generation and implementation of action plans and tools to support site needs and/or to overcome site challenges; works creatively and independently to ensure successful study objectives relative to enrollment and completion goals; examples may include generating strategies for subject recruitment, screening, and/or visit tracking tools
* Oversees and approves clinical data entry into databases, such as following receipt of hard-copy CRFs
* Manages the tracking and accrual of budgeted study activities and the processing of study payments based on site-specific contracts and documentation of data received
* Ensures that site participation is in compliance with all local and federal laws and regulations
* Identifies, negotiates, and manages vendor relationships
* 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
* Performs other duties as required