Senior Site Contracts Specialist - US/LATAM - Remote

Worldwide Clinical Trials - USA; Durham (NC); Remote; USD 60,000 - 85,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Contract Specialist to handle clinical research site contracts and negotiations. The ideal candidate will have 3-5 years of experience in the industry, strong communication and negotiation skills, and knowledge of regulatory requirements. Join a global team that prioritizes diversity and inclusion, and help improve lives through clinical trials.

Qualifications

• 3 to 5 years of experience as a Contract Specialist in Clinical Research, Pharmaceutical, or CRO industry.
• Thorough understanding of FDA, EMA, and ICH-GCP regulatory requirements.
• Excellent verbal and written English language skills.

Responsibilities

• Prepare country contract templates and draft Site Agreements.
• Negotiate contracts and budgets with clinical sites.
• Review and ensure compliance of contractual obligations.

Skills

Negotiating complex contract terms

Resolving contract issues

Excellent communication skills

Time management skills

Understanding of budgeting principles

Education

Bachelor's Degree in business administration or related field

Tools

MS Word

MS Excel

Outlook

Job description

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, 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 proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!

What the Site Contractdepartment does at Worldwide

Site Contracting is an essential function within any CRO, and our seasoned team spans decades of experience within the industry and possesses robust legal experience as well. The department is responsible for reviewing, analyzing, and drafting clinical research site contracts, investigator contracts and other project-related contracts. Our global team is familiar with the specific laws for the countries and sites we occupy. We negotiate and finalize clinical trial contracts and services contracts with the Worldwide Legal Department, study teams, Sponsors, investigators, and/or clinical sites.

What will you do

• Prepare country contract templates; Draft and send Site Agreements or any contracts associated to sites to begin negotiations;
• Finalize contract and budget with sites;
• Reviewing study budgets and costs pertaining to contract negotiation;
• Negotiate contract(s) language and budget(s) with each assigned site to finalization / execution;
• Escalate to Sponsor site requests outside of preapproved parameters;
• If required to provide equipment to the sites, ensure appropriate information or appendix is added in Site Agreements or any document associated;
• Create donation agreement, as applicable;
• Review Site Agreements or any contracts associated for completeness and accuracy;
• Perform quality check of Site Agreements or any contracts associated before signature process starts;
• If requested, provide draft/signed contract/budget to the regulatory team for submission purpose, where needed;
• Liaising with Worldwide Legal Department, Data Privacy team, study teams, Sponsor, sites, investigators etc.
• Send Fully Executed Site Agreements or any document associated to: site, eTMF, payment team, Sponsor, post to internal Sharepoint, as applicable;
• Negotiate Site Agreements Amendment language and budget with sites;
• Create termination letter and send to sites for signature, as applicable;
• Maintain tracking tool with live/real-time updates for functional activities;
• Prioritizes effectively and responds to urgent requests within internal team or Sponsor;

What you will bring to the role

• Proficient in negotiating complex contract terms with clinical sites and vendors and s killed in resolving contract issues and disputes efficiently
• Thorough understanding of international and local regulatory re-quirements for clinical trials (e.g., FDA, EMA, ICH-GCP). Ensures all contracts comply with the latest regulations and guidelines.
• Excellent verbal and written communication skills for effective interac-tion with internal stakeholders and clinical sites
• Ability to identify and correct discrepancies or potential issues in contract documentation.
  Understanding of budgeting and financial principles related to clinical trial contracts and a bility to negotiate cost-effective terms and manage financial aspects of 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

Your experience

• 3 to 5 years of experience as a Contract Specialist in Clinical Research, Pharmaceutical, or CRO industry
• Bachelor's Degree or equivalent in business administration, finance, science or related field.
• Excellent verbal and written English language skills.
• Proficiency with MS Word, Excel and Outlook
• Knowledge and understanding of ICH and GCP Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .

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’reon a mission to hire thevery bestand 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.