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Clinical Research Coordinator

Alphatec Spine

This is a Contract position in Los Angeles, CA posted May 12, 2022.

DescriptionAn ATEC Clinical Research Associate (CRA) or clinical research coordinator (CRC) supports the company’s clinical research initiatives by coordinating and overseeing the successful execution of clinical studies and data collection efforts in partnership with Atec internal research and clinical partners.

Specifically, the position is responsible for research activities spanning from assistance in the development of study documents, to site study start-up and recruitment of study participants, collection and compilation of site study data, monitoring and reporting of site performance and adherence to protocols following Good Clinical Practices, and input toward the reporting of study results.The CRA/CRC is a liaison between ATEC and study sites, and as a customer-facing advocate for ATEC’s mission, is empowered to take initiative and implement process-improving solutions that enable a site to be successful and that support the company’s underlying research objectives.

Internally, the role collaborates closely with other members of the Clinical Strategies department as well as product marketing and field representatives.Essential Duties And ResponsibilitiesAssists in the development of study documents, including: protocols – requiring an interest in and capacity to understand the study objectives and requirements according to good clinical practice guidelines (GCP); case report forms (CRFs) – understanding the flow and format of clinical data acquisition; participant consent forms and other regulatory documents – requiring knowledge of institutional review board (IRB) requirements and processesSupports site selection, initiation, and close-out, liaising with site personnel to obtain, prepare, submit, and track local IRB review and contracting processes; trains site personnel on study proceduresExecute monitoring plans and procedures; monitors site performance to study goals and adherence to study protocols (through both on-site and remote interactions and auditing/querying of CRFs); generates monitoring reports (using analytical and presentation skills) to effectively communicate progress and/or issues to the site and internally to study managementImplements action plans and tools to support site needs and/or to overcome site challenges; works closely with sitepersonnel to ensure successful site participation relative to enrollment and completion goals; examples may include subject recruitment, screening, and/or visit tracking toolsAssists with clinical data entry into databases when necessary, such as following receipt of hard-copy CRFsCoordinates processing of study payments based on site-specific contracts and documentation of data receivedEnsures that site participation is in compliance with all local and federal laws and regulationsCollaborates with other research personnel to generate factual and accurate output from study data, including interim reports, conference abstracts, presentations, manuscripts, product/procedural training and collateralPerforms other duties as requiredRequirementsThe requirements listed below are representative of the knowledge, skill, and/or ability required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Superior problem-solving skills with a understanding of clinical data collection and management methodsKnowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance ICH/GCP, US Code of Federal Regulations (CFR), and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of HelsinkiSuperior organization skills, attention to detail, and the ability to keep detailed, accurate recordsExcellent creative thinking skillsExcellent oral and written communication skillsAbility to travel and on short-notice, and to independently manage travel schedule and logisticsAbility to organize and prioritize workflow to meet established timeframes, while working in a fast-paced and goal-oriented environmentAbility to work within a cross-functional team and matrix management structureAbility to exercise independent judgment consistent with department guidelinesAbility to learn and maintain knowledge of procedures, products and activities of assigned areaProficiency with common computer applications (e.G., Microsoft Word, Excel, PowerPoint, Windows, Internet applications, etc.) requiredFamiliarity with electronic data collection systems is a plus.Education And ExperienceBachelor’s degree is required, with study or experience in a health science concentration preferred.

Minimum 2 years direct experience in CRA/CRC role, preferably in medical device (spine industry a plus), demonstrating knowledge of GCP and research processes.Certificates, Licenses, Registrations CCRP preferredFor roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws.

Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.