Clinical Research Associate

Are you passionate about bringing hope to patients by advancing medical research and contributing to the development of life-changing therapies? Are you looking for career growth, challenges, or simply a more motivating role? At WEP Clinical, we help patients every single day get early access to medicine. We challenge our team to bring thought-provoking ideas to the table and support them in achieving their personal and professional goals. Join our dynamic team as a Clinical Research Associate and see the impact you can make!

Role Objectives:

As a Clinical Research Associate at WEP Clinical, you will be a part of a multi-disciplinary team that provides scientific, statistical, operations, and management support for commercially or federally funded clinical trials, by performing and coordinating all aspects of the clinical monitoring and site management process. You will be responsible for ensuring compliance with ICH Good Clinical Practices, FDA guidelines, local regulations, and WEP Clinical Standard Operating Procedures. You'll conduct on-site or remote visits to assess site adherence to protocol and regulatory requirements, manage required documentation, and ensure patient and site data are audit-ready.

• Team Player
• Detail Oriented
• Problem Solver

• Schedule and perform on-site or remote monitoring visit activities, inclusive of the following study visit types: Site Initiation Visit (SIV), Interim Monitoring Visit (IMV) / Routine Monitoring Visit (RMV), and Close Out Visit (COV)
• Contribute to the development of protocols, study tools, materials, and documentation for clinical sites.
• Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed.
• Review site-level investigational drug accountability and safety event documentation
• Review and verify patient files and records, informed consent, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies; provide training and/or initiate corrective action as required.
• Identify, document, track, and report site protocol deviations and violations as defined within the EAP Monitoring Plan
• Manage query resolution.
• Provide mentoring, training, and co-monitoring of junior team members
• Assist in the development of applicable WEP Clinical Standard Operating Procedures
• Develop applicable document templates, including (but not limited to), Monitoring Plans, Monitoring Visit Reports, Confirmation Letters, Follow-Up Letters, and Query Logs
• Complete, review, and/or submit monitoring reports and query logs
• Address protocol or monitoring-related questions received from clinical sites for assigned programs

• Approximately 1-3 years of on-site and remote monitoring experience; The level/title will be determined as part of the interview process
• BA/BS, preferably in a life science, nursing, pharmacy or related field
• Clinical background preferred
• Broad range of therapeutic experience
• High organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budget
• Superior written and verbal communication skills
• Computer literacy, including proficiency in MS Office and use of EDC systems
• Willingness to travel up to 80%

What We Offer:

Medical, dental, and vision insurance, FSA, HSA

Voluntary short-term and long-term disability insurance

Voluntary life insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid maternity & paternity leave

What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

Expanded Access Programs (EAPs)

Named Patient Programs (NPPs)

Clinical Trial Supplies (Comparator & Ancillaries)

Wren Nursing (Clinical Trial Home Nursing & Clinical Education)

Hospital Supply of Unlicensed Medicines

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

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