Integra LifeSciences Clinical Trial Administrator in Plainsboro, New Jersey
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, reconstructive and general surgery, and regenerative wound care.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 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:
Maintains and coordinates the administrative aspects of lntegra's Clinical Affairs dept. including clinical studies according to GCPs and S0Ps
Provides support for the preparation of clinical study reports, annual reports, interim updates and other study or regulatory documents, as required
Works with study teams to prepare clinical study documents, including investigator meeting materials, site and training information
Serves as a resource for clinical study sites and can triage questions/needs, as appropriate
Implements and maintains clinical filing systems for all shared documents and files and proactively identifies operational process improvements
Files and maintains study documents in the study Trial Master Files (TMFs)
Performs ongoing and final study-level and site-level TMF reconciliation
Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CRO's, vendors, etc.
Assists with the processing of both vendor and site payments
Assists with gathering and tracking clinical trial accruals
Provides accurate progress reports on assigned tasks and projects
Contributes to wider organizational goals and/or activities as assigned
Ensures study compliance by understanding and applying all relevant SOPs
Performs various administrative duties such as travel arrangements, expense reporting, meeting minutes and other administrative duties for the department as needed.
Works with department staff to support and achieve department objectives.
Works with Global Clinical Affairs members at other locations to coordinateand streamline clinical operations worldwide.
The requirements listed below are representative of the knowledge, skill and/or ability required for this position:
Minimum of a Bachelor's degree in a relevant scientific and/or financial discipline
2 years relevant (clinical research and/or finance) experience
Strong written and verbal communication skills
Demonstrated organizational skills
Ability to work independently in a fast-paced team environment
Computer software: Microsoft Word, Excel, PowerPoint, Project, Visio
Experience using a document management system preferred
Basic knowledge and understanding of pharmaceutical regulatory requirements, including FDA and ICH guidelines would be a plus.
Vacancy ID 2018-27845
Position Type Regular Full-Time
Category Clinical Affairs
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran stat