Abbott CRA I - Clinical Research Associate - In-House CRA in St. Paul, Minnesota
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
IN-HOUSE CRA POSITION - NO REMOTE
Primary Job Function
Clinical trial operational site support including all processes related to study start-up. Manages sites through life of trial and close-out.
Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to
procedures and regulations.
- Ensures compliance with protocol and all regulatory policies, procedures and/ or guidelines during clinical studies by training/guidance of investigators/study
- Identifies, evaluates, properly reports and ensures adequate follow-up of
experiences by timely and accurate documentation and appropriate communication.
- Maintains knowledge in regulations for applicable geographies and types of
studies (IDE, non-significant risk, feasibility, exempt, etc.).
- Builds and maintains relationships with sites.
Supervisory / Management Responsibilities Work is closely supervised. Follows specific, detailed instructions.
Position Accountability / Scope Begins establishing and cultivating a network of internal resources to facilitate
completion of tasks. Individual influence is typically exerted at the peer level.
Completes daily work to meet established schedule with guidance from
supervisor on prioritization of tasks. May exercise authority within pre-established limits and approval. Failure to achieve results can normally be
overcome without serious effect on the business.
Bachelor's degree plus 0- years of related work experience with a basic understanding of specified functional area, or an equivalent combination of education
and work experience.
Minimum Experience / Training
** Prefer candidate has a minimum of one (1) year experience as a CRA – Preferably with medical devices.
General knowledge and basic application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Learns to use professional concepts and company policies and procedures to follow. Works on problems of limited scope. Minimal independent decision
making. Entry Level Position. Works under direct supervision.
Uses existing procedures to solve routine/simpler problems.
Collection and review of essential documents in consultation with assigned FCE and/or in-house personnel, including coordination of start-up and maintenance of the clinical study site.
Scheduling of required training (e.g. EDC, CIP). Main point of contact for site communications and questions.
Serves as a liaison to clinical study management, FCEs, site personnel and/or applicable CROs, responding to any CIP related questions/issues and escalating as appropriate.
Communicates and collaborates with all levels of employees, customers, contractors, and vendors. Ensure clinical study sites comply to the assigned CIP and all applicable regulatory standards.
Notify appropriate study management when concerns exist.
Reviews and analyzes data and documents for accuracy and completeness.
Query creation, management and resolution.
Source Document redaction/filing.
Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits (If applicable, in collaboration with CRO).
Review and processes product complaints and adverse events as soon as they are reported. Collaborating with the safety specialists to prepare required materials for CEC meetings.
This may include but is not limited to, obtaining source documents, adjudication form data entry, and assembly of CEC binders.
Assists in the development of study related materials (patient brochures, patient recruitment material, tools and templates and presentations/ newsletters).
Assists in writing sections of the protocol summary, annual report and other study reports.
Assists in the development and review of ICFs to ensure all required elements are included.
Ensuring appropriate translations where applicable. Process improvement activities.
Engages in relevant professional associations or societies.
Seeks continuing education on applicable devices/therapies.
Monthly clinical accrual reporting (sites, vendors, HCPS, Consultants etc) to Project Manager.
Ensuring appropriate site and patient reimbursement in collaboration with the clinical study coordinator.
May make other contributions as assigned.
IN-HOUSE CRA POSITION - NO REMOTE
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com