Clinical Research Associate

We are more than a medical technology company. We are a solution-minded, problem-solving organization committed to providing outstanding patient outcomes. ATEC is committed to delivering safe, effective, and innovative products that exceed expectations though our commitment to continuous process improvement and quality excellence. We accomplish this goal by working closely with clinical experts to design and develop systems to effectively and efficiently drive the future of spine surgery. Our innovative platforms focus on simplifying procedures for the surgeon with the ultimate objective of improving clinical outcomes. Our growth is predicated on our ability to innovate and continually develop technologies that will have a significant impact on patient care.
ATEC Spine has an exciting opportunity for a Clinical Research Associate (CRA) in San Diego, California. An ATEC Clinical Research Associate (CRA) supports the company’s Clinical & Scientific Affairs initiatives by coordinating and overseeing the successful execution of clinical studies and data collection efforts in partnership with our surgical practice partners. Specifically, the position is responsible for research activities spanning from assistance in the development of study documents, to site start-up and recruitment of study participants, collection and compilation of 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 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 & Scientific Affairs department as well as product marketing and field representatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES

• Assists in the development of 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
• Supports 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 procedures
• Develops 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 management
• Generates and implements action plans and tools to support site needs and/or to overcome site challenges; works creatively to ensure successful site participation relative to enrollment and completion goals; examples may include subject recruitment, screening, and/or visit tracking tools
• Assists with clinical data entry into databases when necessary, such as following receipt of hard-copy CRFs
• Coordinates 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
• 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

QUALIFICATIONS:
The 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.

• Typically requires a bachelor's degree and two (2) years direct experience as a Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) role, preferably in medical device (spine industry a plus), demonstrating knowledge of GCP and research processes.
• Certified Clinical Research Professional (CCRP) certification preferred.
• Superior problem-solving skills with a solid understanding of scientific data collection and management methods

• Knowledge, 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 Helsinki
• Superior organization skills, attention to detail, and the ability to keep detailed, accurate records
• Excellent analytical and creative thinking skills
• Excellent oral and written communication skills
• Ability to travel extensively and on short-notice, and to independently manage travel schedule and logistics
• Ability to organize and prioritize workflow to meet established timeframes, while working in a fast-paced and goal-oriented environment
• Ability to work within a cross-functional team and matrix management structure
• Ability to exercise independent judgment consistent with department guidelines
• Ability to learn and maintain knowledge of procedures, products and activities of assigned area
• Proficiency with common computer applications (e.g., Microsoft Word, Excel, PowerPoint, Windows, Internet applications, etc.) required
• Familiarity with electronic data collection systems a plus

Job Type: Full-time