Clinical Research Specialist
Share
Job Location:
Princeton, NJ - USA
Monthly Salary:
$ 71300 - 97750
Posted on:
5 days ago
Vacancies:
1 Vacancy
Job Summary
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 whats 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 Integras 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 bachelors 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:
$71300.00 - $97750.00 USD SalaryOur 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 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 youd 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
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 candidates name resume or background) are position-specific and may only occur within the scope of that approved agreement. Please no phone calls or emails.
Integra - Employer Branding from Integra LifeSciences on Vimeo
Required Experience:
IC
Key Skills
- Laboratory Experience
- Spss
- Data Collection
- Genetics
- R
- Research Experience
- Statistical Software
- Cell Culture
- Molecular Biology
- Microscopy
- Research Laboratory Experience
- Western Blot
About Company
Integra LifeSciences, a world leader in medical technology with headquarters in Princeton, New Jersey, was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Since then, Integra has expanded its base regenerative te ... View more
