Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery.
Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Ensure compliance with ICH – GCP guidelines and all pertinent government regulations for conducting clinical studies.
- Assist in preparation of protocols and documentation for clinical studies, entailing communication with consultants such as surgeons, radiologists and outside statisticians.
- Assist in the IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations.
- Contribute to overall data management such as case report form design, edit check review, data clarification process and evaluating and analyzing clinical data
- Recruit, qualify and train investigators and clinical site personnel (and laboratories, as applicable) for study participation.
- Assist with contract and budget preparation and negotiations.
- Coordinate activities of investigators and clinical site personnel to ensure compliance with the protocol and overall clinical objectives.
- Coordinate the organization of study regulatory files, inventory and all related study materials and supplies.
- Assure data integrity through proper on site monitoring, verification of source records, documentation of protocol deviations, and completion of written reports, in accordance with department Standard Operating Procedures (SOPs).
- Communicate with clinical sites to expedite the exchange of information and to ensure that clinical studies are kept on schedule and within budget.
- Assist with the implementation of investigator meetings and general clinical meetings (as applicable).
- Ensure subject safety in all areas of clinical research, following procedures to report AEs, SAEs and UADEs to clinical, regulatory and quality management.
- Contribute to obtaining government approvals and preparing progress reports for clinical studies.
- Promote good communication with investigational sites, within the clinical department, as well as between other Integra department members.
- Assist R&D, marketing, and other departments in performing their duties, as appropriate.
- Maintain awareness of current issues in clinical research by reading relevant literature and attending industry meetings and other training opportunities.
- Assist in various projects and other duties as assigned.
- Education: Bachelor’s degree, preferably in a life science or scientific related field, or RN or BSN degree or 10+ years of recent and relevant clinical research/monitoring experience.
- Experience: Four year or more experience in clinical research, with a minimum of two to four years’ experience in independent coordination of investigational site activity by on-site monitoring and site communications.
- Intermediate knowledge and understanding of FDA regulations and ICH – GCP guidelines.
- Must work both independently and in a team environment.
- Proven track record of on-site monitoring of investigational sites and constructive site collaboration.
- Ability to review and interpret medical records through knowledge and general application of medical terminology.
- Excellent interpersonal, written communications, time management, and organizational skills.
- Detail oriented with good problem solving skills.
- Ability to manage multiple tasks and take ownership and workflow initiative.
- Proficient computer skills using Microsoft Office products.
- Experience with electronic data capture (EDC) is a plus.
- Presentation skills desired. PHYSICAL REQUIREMENTS: The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
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