Senior Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide logistical assistance for clinical study operations, encompassing study initiation, supplies management, site qualification, initiation, oversight, monitoring, and closure.

• Create study documents such as protocols, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and submissions to ethics committees.

• Oversee the management of study contracts, budgets, invoicing, and payments for clinical trial vendors and investigative sites.

• Assist Clinical Data Management with case report forms, completion guidelines, and Electronic Data Capture (EDC) testing.

• Organize, manage, file, and archive clinical documentation and reports in accordance with Standard Operating Procedures (SOPs) and study requirements.

• Supervise the collection, processing, shipment, storage, and tracking of biospecimens.

• Train Contract Research Organizations (CROs), vendors, investigators, and study coordinators on study requirements while providing guidance on site-related issues.

• Monitor the progress of clinical trials and deliver status updates to stakeholders.

• Develop and adhere to monitoring plans to detect protocol deviations and data discrepancies.

• Conduct consent processes, ethics board submissions, and track participant data and samples for studies where Natera acts as a clinical research site.

• Revise Clinical Department SOPs as necessary.

• Collaborate with Natera's research and development teams to meet project deliverables.

• Carry out additional assigned duties as required.

• Handle Protected Health Information (PHI) in both paper and electronic formats utilizing relevant technologies.

• Complete and uphold training in HIPAA/PHI privacy, Human Subjects Protection, Good Clinical Practice (GCP), policy compliance, and security protocols.

• Successfully pass a post-offer criminal background check.

⛳️ Requirements

• Bachelor’s degree in life sciences, a related field, or equivalent experience.

• At least 4 years of experience in clinical studies within academia, biopharma, diagnostics, or medical device industries.

• Proficiency with clinical Electronic Data Capture (EDC) systems.

• Understanding of Trial Master File organization and structure.

• Knowledge of biosample management, sample processing, and best practices in biobanking.

• Familiarity with SOPs, ICH-GCP, and FDA regulations.

• Proficient in Microsoft Word, Excel, and PowerPoint.

• Capability to work independently and lead project initiatives.

• Strong analytical skills with the ability to identify complex problems and propose solutions.

• Excellent written and oral communication abilities.

• Outstanding writing skills.

• Detail-oriented with strong organizational and time management skills.

• Current or completed training in HIPAA/PHI privacy, Human Subjects Protection, and GCP.

• Maintain up-to-date Natera training requirements, including adherence to general policies, compliance procedures, and security training.

• Pass a post-offer criminal background check.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.

• Complimentary testing for Natera employees and their immediate family members.

• Fertility care benefits.

• Leave for pregnancy and baby bonding.

• 401(k) retirement plan benefits.

• Commuter benefits.

• Employee referral program.

• Commitment to being an Equal Opportunity Employer with a diverse and inclusive workplace.