Clinical Trials Contract Specialist

United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Diagnostics, Medical DevicesIndustries

Requirements

Candidates must possess a Bachelor's degree, preferably in a scientific discipline, and have a minimum of 5 years of experience in clinical studies within the biopharma, diagnostics, or medical device sectors. A minimum of 3 years of experience negotiating investigator site agreements is required, along with familiarity with clinical EDC systems, SOPs, ICH-GCP, and FDA regulations. Proficiency in Google Workspace and MS Office Suite is essential, and experience with Salesforce, contract management, and enterprise systems is preferred.

Responsibilities

The Clinical Trials Contract Specialist is responsible for developing, negotiating, and managing clinical trial agreements, ensuring compliance with regulatory requirements and institutional policies. This includes drafting, reviewing, and negotiating various agreements such as NDAs, CTAs, CSAs, SOWs, and ISAs, and serving as the primary contact for contract-related inquiries. The specialist will maintain contract files, monitor milestones, provide guidance to study teams, mitigate contractual risks, and participate in process improvement initiatives.

Skills

Clinical Trial Agreements (CTAs)

Non-Disclosure Agreements (NDAs)

Statements of Work (SOWs)

Investigator Sponsored Agreements (ISAs)

Contract Negotiation

Contract Management

Regulatory Compliance

FDA Regulations

Biopharma

Diagnostics

Medical Device

Natera

Genetic testing and diagnostics solutions provider

About Natera

Natera focuses on genetic testing and diagnostics, providing advanced solutions for cancer patients, transplant patients, and individuals assessing hereditary health risks. Their main technology is cell-free DNA (cfDNA) testing, which analyzes DNA fragments in the blood to detect minimal traces of cancer and assess organ health. Natera stands out by offering specialized tests like the Signatera ctDNA test and Panorama NIPT, along with genetic counseling services. The company's goal is to improve patient care and health outcomes through accurate genetic testing.

Austin, TexasHeadquarters

2004Year Founded

$149.9MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Flexible medical plans

Investment options

Time off

Workplace perks

Risks

Hindenburg report accuses Natera of deceptive sales practices, risking legal challenges.

New Prospera Heart features may face slow adoption by healthcare providers.

Fetal RhD NIPT demand may drop post-RhIg shortage, affecting future sales.

Differentiation

Natera's Signatera test offers personalized ctDNA analysis for cancer patients.

Prospera Heart test uses unique Donor Quantity Score for transplant rejection detection.

Panorama NIPT test is a leader in non-invasive prenatal testing with 2 million tests.

Upsides

Increased adoption of liquid biopsy techniques boosts demand for Natera's cfDNA tests.

AI integration enhances accuracy and speed of Natera's cfDNA analysis.

Growing personalized medicine trend aligns with Natera's customized genetic tests.

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