Clinical Research Specialist

Integra LifeSciences is a global medical technology leader in neurosurgery and regenerative medicine driven by our purpose of restoring patients’ lives. The company offers a broad portfolio of products and innovative solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Its regenerative tissue technologies include products that address soft tissue, peripheral nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

Founded in 1989 by Richard E. Caruso, the company is headquartered in Princeton, New Jersey. Today, Integra LifeSciences has grown immensely, with more than 4200 employees worldwide as well as offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas.

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Responsible for filing and maintaining study documents in the study Trial Master Files (TMFs)
• Responsible for performing ongoing and final study-level and site-level TMF reconciliation
• Maintains and coordinates the administrative aspects of Integra’s Clinical Affairs dept. including clinical studies according to GCPs and S0Ps.
• Provides support to study teams in the preparation of clinical study documents, including investigator meeting materials, site, and training information as well as other study or regulatory documents, as required
• Implements and maintains clinical filing systems for all shared documents and files and proactively identifies operational process improvements
• Responsible for processing of vendor and site payments for assigned studies.
• Responsible for entering and tracking clinical trial accruals for assigned studies
• Performs various administrative duties such as preparing meeting minutes and other administrative duties for the department as needed.

INTERACTIONS/RELATIONSHIPS:

• Works with department staff to support and achieve department objectives.
• Works with Global Clinical Affairs members at other locations to coordinate and streamline clinical operations worldwide.

Education: Minimum of a bachelor’s degree in a relevant scientific and/or financial discipline

Experience: Two (2) or more years relevant (clinical research and/or finance) experience

Specific competencies:

• 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.

Salary Pay Range:

$71,300.00 – $97,750.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following

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 status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.