Role OverviewWe're seeking expert evaluators in Clinical, Biomedical, or Pharma to assess…See this and similar jobs on LinkedIn.

Extraordinary Careers. Endless Possibilities. With the nation’s largest home infusion provider, there is no limit to the growth of your career.

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Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

You will:

• Act as the main line of communication between the project team, sponsor, and the site
• Build and maintain a good relationship with the site staff involved in the study conduct
• Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
• Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
• Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
• Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
• Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
• Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
• Ensures quality (data integrity and compliance) at site level
• Conduct site audit preparation visits and resolve site audit findings
• Participate in study site audits and client onsite visits, as required
• Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
• Conduct project-specific training of site investigators
• Support preparation of Investigator newsletters
• Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
• Support preparation of draft regulatory and ethics committee submission packages
• Support collection of IP-RED packages at site/country level
• Facilitate review and reconciliation of the study TMF on country and site levels

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Located in the Central or West Coast regions is preferred
• Must have 2+ years of independent on-site monitoring experience
• Experience in all types of monitoring visits, in phases I-III
• Experience in Oncology mandatory & GI preferred and/or radio-pharm experience preferred.
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel up to 75%
• Valid driver’s license (if applicable)

For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Additional Information

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

PRIMARY RESPONSIBILITIES:

Leverage multiple information sources, including LIMS, to review cases for accuracy and completeness of pathology tissue samples for Signatera and Altera testing.

Interpret pathology reports, clinical notes and additional testing reports to complete light data entry for each tissue sample.

Collaborate with team members to work to resolve potential discrepancies.

Ensure that necessary notes and holds are placed on cases for non-conforming samples, discrepancies and/or missing information and escalated to ensure timely resolution.

Confirm cancer types for the reporting team before the report is issued via emails and spreadsheet.

Meet daily case metrics.

Attend interdepartmental meetings.

Provide feedback on the current process or workflow.

Review and understand all SOPs.

This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job Employee must complete training relating to HIPAA/PHI privacy.

QUALIFICATIONS:

BS/BA degree (preferred)

High School Diploma (or equivalent) required.

2+ years of medical industry related experience - pathology preferred.

Previous data entry experience is required.

KNOWLEDGE, SKILLS, AND ABILITIES

Trained on all product types and able to QC with high accuracy and efficiency consistently.

Ability to handle most escalations, discrepancies, and holds.

Firm understanding and knowledgeable in all aspects of the Sample Review process and SOPs.

Typing speed of at least 45wpm with high accuracy.

Excellent oral and written communication.

Excellent critical thinking skills and the ability to use good judgment.

Ability to perform required duties with a high degree of accuracy and attention to detail.

Positive attitude and ability to work well with others.

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:

- BBB announcement on job scams

- FBI Cyber Crime resource page

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