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About the Role

Join the dynamic team at WEP Clinical, where your role will contribute significantly towards impactful clinical research efforts that improve outcomes for both clients and patients. This mission-driven organization promotes innovation and teamwork, encouraging contributions that make a real difference in advancing clinical trials and patient care.

Role Objectives and Responsibilities

Coordinate and execute all aspects of clinical monitoring and site management for both commercial and federally funded trials.
Ensure adherence to ICH Good Clinical Practice standards, FDA regulations, local laws, and internal SOPs of WEP Clinical.
Conduct on-site or remote visits to verify site compliance with protocol and regulatory requirements and manage related documentation.
Perform monitoring visit activities including Site Initiation Visits (SIV), Interim/Routine Monitoring Visits (IMV/RMV), and Close Out Visits (COV).
Support development of clinical trial protocols, study tools, and site materials.
Provide constructive feedback to sites to resolve deficiencies and ensure corrective actions.
Review investigational drug accountability and safety event documentation at the site level.
Check patient files, informed consent forms, case report forms, and source documents for thoroughness and compliance, and initiate training or corrections as needed.
Identify, track, and report protocol deviations and violations according to the EAP Monitoring Plan.
Manage resolution of data queries and collaborate with team members for quality oversight.
Mentor and train junior clinical research staff and assist in SOP development and optimization.
Create and maintain documentation such as Monitoring Plans, Visit Reports, Confirmation and Follow-Up Letters, and Query Logs.
Respond to protocol or monitoring-related queries from clinical sites.

Candidate Profile

Minimum of 1 year experience in on-site and remote clinical monitoring; specific level and title determined during interview.
Bachelor’s degree preferably in life sciences, nursing, pharmacy, or related fields.
Clinical experience and broad therapeutic area knowledge preferred.
Strong organizational, logistics, and multitasking skills to manage multiple sites effectively within time and budget constraints.
Excellent communication skills, both written and verbal.
Proficiency with computer applications including MS Office and Electronic Data Capture systems.
Willingness to travel up to 80% of the time.

Eligibility and Location Restrictions

This role is open to candidates residing in U.S. states where WEP Clinical is authorized to hire, excluding California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and the District of Columbia.

Benefits and Work Environment

Comprehensive medical, dental, and vision insurance coverage.
Flexible spending accounts (FSA) and health savings accounts (HSA).
Optional voluntary insurance plans including Critical Illness, Hospital Indemnity, and Accident Insurance.
Group short-term and long-term disability insurance.
Group life insurance.
401(k) safe harbor plan with company match.
Paid time off including vacation, holidays, sick days, and volunteer time.
Paid maternity and paternity leave.

Company Overview and Culture

WEP Clinical is a global partner for biopharmaceutical companies, facilitating treatments to reach patients effectively through services like clinical trials, home health services, expanded access programs, and market access consultancy. With over 15 years of international experience supporting programs in more than 150 countries, we combine operational scale with agile, personalized service. The company champions integrity, accountability, inclusion, and the professional growth of its team members.

Additional Information

Data privacy is a priority, with full compliance to the company's privacy policies during recruitment. The hiring process involves an AI screening tool, ensuring fair, consistent candidate evaluation before human decisions are made. WEP Clinical maintains a smoke-free, drug-free, and alcohol-free workplace, and is an equal opportunity employer committed to reasonable accommodations and non-discrimination across all employment procedures.

Clinical Research Associate