Clinical Research Associate- Midwest region

Job Description

Job Description

Description:

SUMMARY:

Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias.

Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions.

Our lead drug candidate, Saroglitazar, is a liver-selective, dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA). As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow.

RESPONSIBILITIES:

• Responsible for of all aspects of site monitoring activities; Including the conduct of Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Periodic Monitoring Visits (PMVs) and Close-out Visits (COVs) in accordance with ICH/GCP principles.
• Act as the primary contact/ manager for sites to include, but not limited to the following activities:
• Provide proper training and guidance to site staff on the protocol and all study related materials
• Ensure appropriate safety monitoring, per ICH/GCP principles, are reviewed on an ongoing basis and ensure site has proper oversight of safety reporting requirements
• Acts as the primary contact to assigned sites to ensure there is proper compliance to the protocol, adherence to patient safety, proper IP management and study supply management
• Review sites recruitment and enrollment activities and assist with recruitment planning and solutions as needed.
• Ensure proper review of the sites Investigational Site File Binder and ensure all plans, communications and logs are maintained and updated appropriately as per ICH GCP and GDP requirements
• Will provide support to all functional groups (as needed) to ensure proper reporting of safety data and proper site compliance to all protocol and protocol related materials
• Will perform site oversight to prevent noncompliance, escalate noncompliance issues and provide guidance/ preventative action plan to prevent future noncompliance as needed

Requirements

QUALIFICATIONS – SKILLS & REQUIREMENTS:

• Must display proper knowledge of ICH GCP principles and GDP knowledge for compliance with document review/ reporting; ALCOA principles
• Must be able to demonstrate proper organizational skills and have effective communication skills.
• Must be able to work independently managing sites with minimal oversight
• Must be able to demonstrate ability to conduct presentations as necessary
• Must be able to assist and have experience with oversight of sponsor monitoring activities. This will include: Data interpretation, conflict resolution and demonstration of working with different personnel, & provide guidance and solutions for complex issues
• Must have basic knowledge of system tools and web based applications that include, but not limited to:

Microsoft Outlook, Excel, Word and Powerpoint

CTMS, EDC, eTMF and IWRS systems

TRAVEL:

• Travel is required for the position; this may be extensive at times (70-80%).

WORK ENVIRONMENT:

This position is remote, but from time to time or when required, the employee will be required to report to our office, located in our office in Pennington, NJ. The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is:

• Frequently required to sit and/or stand, walk, talk, and hear.

• Ability to sit at a computer for an extended period of time.

• Vision ability requirements include clarity of visions at 20 inches or less due to computer work.

• Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic).

• Constantly required to use hands and fingers to operate office machines and equipment.

• Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch.

The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job.

Zydus Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Zydus is committed to providing reasonable accommodation to, among others, individuals with disabilities and disabled veterans. If you need an accommodation because of a disability to search and apply for a career opportunity with Zydus, please contact us and let us know the nature of your request.