Job Title: Clinical Contract Assistant

Location: Onsite Sylmar, CA or Maple Grove, MN

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.