Clinical Research Specialist

Integra LifeSciences • Princeton, FL

7d

About The Position

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.

Requirements

• Minimum of a bachelor’s degree in a relevant scientific and/or financial discipline
• Two (2) or more 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
• Microsoft Word, Excel, PowerPoint, Project, Visio

Nice To Haves

• Experience using a document management system preferred
• Basic knowledge and understanding of pharmaceutical regulatory requirements, including FDA and ICH guidelines would be a plus.

Responsibilities

• 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.
• 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.

Benefits

• 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 https://jobs.integralife.com/total-rewards/

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level