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About the Role

Site Contracting is an essential function within any CRO, responsible for reviewing, analyzing, and drafting clinical research site contracts, investigator contracts, and other project-related contracts. Our global team is familiar with specific country and site laws, negotiating and finalizing clinical trial and services contracts.

Responsibilities

• Prepare country contract templates.
• Draft and send Site Agreements or any contracts associated to sites to begin negotiations.
• Provide site contract execution planned timelines and site negotiation status.
• Send items for translation, if applicable.
• Receive and translate items.
• Review study budgets and costs pertaining to contract negotiation.
• Negotiate contract language and budgets with each assigned site to finalization/execution.
• Escalate site requests outside of pre-approved parameters to the Site Contracts Lead for Sponsor forwarding.
• Escalate risks and non-responsive sites to the Site Contracts Lead or internal team.
• Ensure appropriate information or an appendix is added in Site Agreements or any associated documents if equipment is provided to sites.
• Create a donation agreement, as applicable.
• Review Site Agreements or any contracts associated for completeness and accuracy.
• Finalize contract and budget with sites.
• Perform quality checks of Site Agreements or any documents associated before the signature process.
• Provide draft/signed contract/budget to the regulatory team for submission purposes, where needed.
• Liaise with Worldwide Legal Department, Data Privacy team, study teams, Sponsor, sites, and investigators.
• Facilitate contract signatures by Worldwide, when applicable.
• Send Fully Executed Site Agreements or any document associated to site, eTMF, payment team, Sponsor, and post to internal SharePoint, as applicable.
• Negotiate Site Agreements, Amendment language, and budget with sites.
• Create a termination letter or any other related document and send to sites for signature, as applicable.
• Maintain a tracking tool with live/real-time/regular updates for functional activities.
• Prioritize effectively and respond to urgent requests within an internal team or the Sponsor.

Requirements

• Contract Negotiation/Proficient in negotiating contract terms with clinical sites and vendors.
• Ability to identify and address contract issues and disputes efficiently.
• Regulatory Compliance/Good understanding of international and local regulatory requirements for clinical trials (e.g., FDA, EMA, ICH-GCP).
• Ensure all contracts comply with the latest regulations and guidelines.
• Technical Proficiency/Proficiency in contract management software and tools.
• Strong problem-solving skills to address and resolve contract-related issues.
• High level of accuracy in reviewing and drafting contracts.
• Ability to identify and correct discrepancies or potential issues in contract documentation.
• Understanding of budgeting and financial principles related to clinical trial contracts.
• Ability to negotiate cost-effective terms and manage financial aspects of contracts.
• Basic understanding of legal terminology and principles related to contracts.
• Ability to work closely with legal counsel to ensure all contracts meet legal and regulatory requirements.
• Strong time management skills to meet deadlines and manage the contract lifecycle efficiently.
• Ability to handle high volumes of work and work under pressure.

Skills

• Contract Negotiation
• Regulatory Compliance
• Technical Proficiency
• Problem-solving
• Accuracy
• Budgeting
• Financial principles
• Legal terminology
• Time management
• MS Word
• MS Excel
• MS Outlook

Experience Level

• 1 to 3 years of experience in Clinical Research, Pharmaceutical, or CRO industry working with investigator/site contracts or related legal field.

Education Level

• Bachelor's Degree or equivalent in business administration, finance, science or related field.

About the Company

• Worldwide Clinical Trials is a global team of over 3,500+ experts, bright thinkers, dreamers and doers changing the way the world experiences CROs.
• Our mission is to work with passion and purpose every day to improve lives.
• We believe everyone plays an important role in making a world of difference for patients and their caregivers.
• We are committed to enabling professionals from all backgrounds and experiences to succeed.
• We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.
• We are a workplace where people thrive by being themselves and are inspired to do their best work every day.
• We are a team of clinicians, scientists, and researchers who want to make healthcare better.
• We were founded on an unwavering commitment to authentic, personalized attention.
• As CROs consolidate and the industry changes rapidly, personalized attention is more important than ever.

Equal Opportunity

• Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.
• We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful.
• We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.
• We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.