Clinical Research Associate/Bilingual (Spanish Speaking)

Would you like to work for a global company with small company values like teamwork and a commitment to excellence? At Novum, our mission is to ensure excellence where everyone works as an integral part of the team to get the job done? We have a commitment to an ongoing learning process and professional development. As part of the Novum Pharmaceutical Research Services team you will work with inspiring managers and talented coworkers who are all empowered to make significant and lasting contributions to the world we live in.

The Clinical Research Associate is Responsible for independent monitoring of multi-site assignments for Clinical Studies. Ensure adherence to Good Clinical Practices, investigator integrity and compliance with protocol and study procedures, at Investigator sites, in accordance with Novum SOP’s.

Essential Responsibilities:

• Review Regulatory Documents from Investigator Sites for completeness and accuracy.
• Bilingual in Spanish and English
• Conduct site selection, initiation, close out and interim monitoring visits at assigned Investigator sites.
• Review study site data to ensure compliance with the study protocol.
• Verify CRF’s with source documentation.
• Track SAE’s reporting at Investigator Sites.
• Meet with Sponsor representatives as requested.
• Review site’s regulatory binder to ensure that the master study files contain the most up to date information.
• Review site’s drug accountability logs per patients and overall.
• Monitor informed consents signed by study patients to ensure that the patients were consented properly and with the current revision.
• Work with sites to resolve queries in a timely manner.
• Other duties as assigned.

Qualifications:

• Bachelor's degree from a four-year college or university; or one to two years clinical research experience and/or training; or equivalent combination of education and experience.
• 80% travel required which may include international travel.
• Working knowledge of MS Office software.

Licensing/Certification Requirements:

• Valid Driver’s License is required.

Novum 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.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.