
Medasource
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Job Title: Clinical Contract Assistant
Location: Remote
Client: Large Life Sciences Company
Start Date: 3/03/2025
Duration: 9-month contract with the possibility of extension
Position Summary:
Working under the direction of the Contracts Manager, applies general knowledge of business developed through education or past experience. No supervisory responsibilities; accountable for personal contribution to team. Uses existing procedures to solve standard problems; analyzes information and standard practices to make judgments. Works within standardized procedures and practices to achieve objectives and meet deadlines; Supports team with entry level tasks. Exchanges straightforward information, asks questions and checks for understanding.
WHAT YOU’LL DO:
• Creating and negotiating Amendments
• Preparing study-site specific budget drafts
• Sending initial contract/budget email to invited sites within specified timelines
• Periodic follow up with sites
• Submitting finalized contracts for signatures
• Scanning of fully executed contracts and revised Investigator agreements
• Uploading of documents to electronic trial master file system and maintaining status notes
• Attending calls and providing regular status updates as required
• Filing of hard copy contracts
• Preparing NTA agreement templates and sending out to sites
• Licensing requests
• Supporting Contracts Manager & Associates as required on assigned tasks
EDUCATION AND EXPERIENCE YOU’LL BRING
Required:
· Minimum of 1-3 years related work experience in Contracting
· Associate Bachelor’s Degree in Business Administration, a related field, or equivalent.
· Negotiations/Skills in redlining documents and analytical experience or equivalent.
· Familiarity with grant and contract requirements, policies, and procedures including, but not limited to:
· Clinical and AdvaMed Code of Ethics on Interactions with Health Care Professionals.
· Knowledge and understanding of GCP, ICH, GLP and other federal, state, industry rules and regulations governing technical aspects of clinical grants and contracts
· Ensure all required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).
· Requires a demonstrated knowledge of the practices/procedures of the function, company polices, and programs.
· Requires demonstrated written and verbal communication, interpersonal, presentation, technical, analytical, statistical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees.
· Consistently demonstrates the ability to understand and take effective approaches to varying levels of communication that would be most efficient and productive.
· Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner.
· Must have the demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies, and tasks.
· Must have demonstrated personal computer skills including a working familiarity with relevant word processing, database, and
spreadsheet applications (i.e., Microsoft Word, Excel and Access). Some evaluation, originality, and/or ingenuity required.
Preferred:
Bachelor’s Degree in Business Administration, a related field, or equivalent.
Sponsor Pharma or Biotech experience preferred. Direct knowledge of Sponsor Clinical
Contracting and clinical research preferred.
For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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