Manage and develop department personnel as assigned, including performance evaluations and employee relations
Administrative responsibilities relative to personnel management including but not limited to timesheets, tracking, and time-off requests
Manage training efforts of fellow department colleagues
Global Site Contracts – Confidentiality Agreements (CDA)
Draft CDA templates and fallback language and obtain approval by sponsor
Initiate and maintain contact with key investigational site staff throughout the course of the CTA negotiation and signature process
Develop and maintain contract language within approved guidelines and work with legal counsel on CTA negotiation as needed
Attend internal and external project team meetings and report on CDA progress
Maintain study and site-specific CDA study start-up metrics
Global Site Contracts - Clinical Trial Agreements (CTA)
Draft CTA templates and fallback language and obtain approval by sponsor
Obtain applicable international CTA templates and process according to strict national and/or regional laws/policies
Initiate and maintain contact with key investigational site staff throughout the course of the CTA negotiation and signature process,
Develop and maintain contract language within approved guidelines and work with legal counsel on CTA negotiation as needed
Support Regulatory Affairs to ensure appropriate documentation is available for submission to local regulatory authorities, including drafting and processing Powers of Attorney in accordance with local law
Coordinate with Clinical Operations to ensure timely completion and incorporation of study site budgets and payment terms for each CTA
Attend internal and external project team meetings and report on CTA progress
Maintain study and site-specific CTA study start-up metrics
Maintain working knowledge of the internal study start-up module for all assigned studies
Prospective Client CDAs
Draft, review, negotiate, execute and file Company prospective client CDAs
Liaison with business development department regarding prospective client CDAs ensuring timely execution of CDAs.
Maintain CDA tracking using Financial Force platform
Maintain CDA electronic archives
Vendor Contracts
Liaison with Company Legal Counsel with contract preparation, review, revision, execution, tracking and filing of a wide variety of study-related vendor contracts (i.e. equipment rental agreements, questionnaire usage agreements, etc.)
Consultant (Independent Contractor) Program
Process and manage new consultant agreements and maintain files
What You'll Bring:
Detail-oriented and highly organized
Customer service oriented
Maintain the highest level of confidentiality in ALL situations
Ability to effectively communicate information to employees both verbally and in writing
Ability to multi-task, track and stay organized in a fast paced, changing environment
Ability to effectively use information technology, including a laptop computer and Microsoft software systems
Ability to maintain a consistent workload of several hundred contracts
Associate degree
At least 5 years of experience in a clinical site contract processing/management role
Why CTI?
We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
Our culture is unparalleled – Click here to learn more about “The CTI Way”
We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)
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 directly via Microsoft Teams Messaging or text message
We will never ask for your bank account information at any point during the recruitment process
Equal Opportunity Employer/Veterans/Disabled
Numbers & Facts
Location
Covington, Kentucky
Website
https://ctifacts.com
Skills
Administrative Skillsunmatched
Budgetingunmatched
Business Developmentunmatched
Clinical Trialunmatched
Communication Skillsunmatched
Computer Softwareunmatched
Computer Telephony Integration (CTI)unmatched
Consultingunmatched
Contact Managementunmatched
Contract Creationunmatched
Contract Managementunmatched
Contract Processingunmatched
Customer Support/Serviceunmatched
Detail Orientedunmatched
Documentationunmatched
Employee Relationsunmatched
File Maintenanceunmatched
Information Technology & Information Systemsunmatched
Laptop PCunmatched
Legalunmatched
Mentoringunmatched
Metricsunmatched
Microsoft Product Familyunmatched
Multitaskingunmatched
Negotiation Skillsunmatched
Organizational Skillsunmatched
People Managementunmatched
Performance Analysisunmatched
Performance Reviewsunmatched
Progress Reportsunmatched
Regulationsunmatched
Regulatory Submissionsunmatched
Sales Prospectingunmatched
Short Messaging Service (SMS)unmatched
Startupunmatched
Team Buildingunmatched
Time Managementunmatched
Time Trackingunmatched
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