Site Contract Specialist

CTI Clinical Trial and Consulting Services; Polska; Hybrid; PLN 253,000 - 350,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Parental leave

Vacation packages

Job summary

CTI Clinical Trial and Consulting Services is seeking a detail‑oriented paralegal/administrative professional to support CDA and CTA processes. You will initiate site communications, draft and negotiate terms with sponsor guidelines, and maintain meticulous contract files across multiple studies.

The role requires at least two years in an administrative/business setting, with preferred exposure to pharmaceutical contracts.

Qualifications

• Paralegal certification or an Associate’s degree is required.
• Two years of experience in a professional administrative/business role.
• Experience in a pharmaceutical company or a CRO is preferred.
• Basic knowledge of medical and pharmaceutical terminology is preferred.

Responsibilities

• Initiate site contact and follow-up as necessary for CDA/CTA drafts.
• Administer contract language within sponsor guidelines and coordinate with legal counsel on revisions.
• Facilitate CDA and CTA completion and execution.
• Attend internal and external project team meetings and report on CDA/CTA progress.
• Maintain contract files and internal/external CDA/CTA tracking sheets.
• Update CTA status in the study start-up module for assigned studies.
• Assist with contract preparation, review, revision, execution and filing.
• Advise on significant terms such as expiration dates and renewal terms.
• Assist with CDA preparation, review, negotiation, execution and filing.
• Maintain CDA tracking and archives.
• Process new consultant paperwork and maintain files.

Education

Paralegal certification or Associate’s degree

Job description

• Initiate site contact and follow-up as necessary to turn study confidentiality agreements (CDA) and study clinical trial agreement (CTA) drafts
• Administer contract language to ensure it remains within approved sponsor guidelines and work with legal counsel on contract revision and negotiation
• Facilitate CDA and CTA completion and execution
• Attend internal and external project team meetings and report on CDA and CTA progress
• Maintain contract files and internal/external CDA and CTA tracking sheets
• Update CTA status within the internal study start-up module for all assigned studies
• Assist with contract preparation, review, revision, execution and filing
• Advise appropriate parties of significant terms (e.g. expiration dates, renewal terms, compliance obligations, etc.)
• Assist with CDA preparation, review, negotiation, execution and filing.
• Maintain CDA tracking
• Maintain CDA archives
• Process new consultant paperwork and maintain files

What You'll Do

• Initiate site contact and follow-up as necessary to turn study confidentiality agreements (CDA) and study clinical trial agreement (CTA) drafts
• Administer contract language to ensure it remains within approved sponsor guidelines and work with legal counsel on contract revision and negotiation
• Facilitate CDA and CTA completion and execution
• Attend internal and external project team meetings and report on CDA and CTA progress
• Maintain contract files and internal/external CDA and CTA tracking sheets
• Update CTA status within the internal study start-up module for all assigned studies
• Assist with contract preparation, review, revision, execution and filing
• Advise appropriate parties of significant terms (e.g. expiration dates, renewal terms, compliance obligations, etc.)
• Assist with CDA preparation, review, negotiation, execution and filing.
• Maintain CDA tracking
• Maintain CDA archives
• Process new consultant paperwork and maintain files

What You'll Bring

• Paralegal certification or Associate’s degree
• At least two years of experience in a professional administrative/business role
• Experience working in or with a pharmaceutical company or a Clinical Research Organization (CRO) (preferred)
• Basic knowledge of medical and pharmaceutical terminology (preferred)

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process