Position: Senior Clinical Research Associate

FLSA Status: Exempt

Location: Remote (East Coast USA Preferred)

Salary: $110,000 to $125,000 D.O.E

Unfortunately, we cannot support work visa permit applications for this role

Join our dynamic team at Pharmaron where innovation meets excellence in clinical research.

As we continue to grow, we are seeking to add a skilled Senior Clinical Research Associate to join our team and play a pivotal role in supporting critical projects that shape the future of medicine.

This role remote role based in the USA however up to 50% travel across the USA will be required.

What you will do:

As a Senior Clinical Research Associate, you will carry out responsibilities to set up, monitor and close-down clinical studies.

In addition:

• Verify compliance with protocol, Good Clinical Practices, and regulatory requirements.
• Conduct monitoring visits according to the monitoring plan.
• Identify and report safety issues to the sponsor and IRB/IEC.
• Perform monitoring activities per the plan (e.g., source document verification).
• Review site records for accuracy and completeness.
• Ensure accountability of Investigational Product and related supplies.
• Ensure sites implement corrective and preventive actions for inspection readiness.
• Generate confirmation and follow-up letters for each visit.
• Submit regulatory documents as required.
• Ensure compliance with serious adverse event reporting requirements.
• Update CTMS/e-TMF/Tracking System and report to Project Manager.
• Assist in preparing and conducting investigator meetings.
• Follow study protocol and procedures.
• Escalate site issues as needed.
• Complete required training and stay updated on Sponsor information.
• Produce monitoring reports according to timelines.
• Obtain documents and information required for the trial.
• Maintain ISF and TMF documents accurately.
• Ensure compliance with quality standards.

What We are Looking for:

Your expertise as a Clinical Research Associate, coupled with your strong grasp of clinical research study protocols and your adeptness at integrating and adhering to Good Clinical Practice (GCP) and regulatory standards, constitute essential skills that will drive success in this role.

Qualifications and Experience:

• BA degree or RN or higher, preferably in sciences/medical sciences, or equivalent experience.
• At least 5 years of clinical monitoring experience in the pharmaceutical industry or clinical research site-based experience.
• Experience in Oncology phase I/II and Ophthalmology any phase 
• Knowledge of ICH GCP guidelines.
• System experience preferred: (i.e. CTMS, EDC, eTMF, etc.)
• Excellent attention to detail
• Excellent Visual acuity - Including color perception, depth perception, and field vision. Close visual acuity is necessary for tasks such as preparing and analyzing data, transcribing, and extensive reading.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

#LI-ZS1