Senior Clinical Research Associate
Company: Novum Pharmaceutical Research Services
- Location: Miami-Fort Lauderdale Area, United States
- Work mode: Remote
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Company Description Novum Pharmaceutical Research Services is a global Contract Research Organization (CRO) that provides comprehensive clinical research services to the pharmaceutical industry. For over 50 years, Novum has led the conduct of clinical trials, from First-in-Human and large bioequivalence studies at its Early Phase. The organization delivers full-service, turnkey support for drug development programs, guided by experienced leadership in science, operations, quality assurance, medical affairs, and project management. Novum’s expertise spans Early Phase studies, including PK/PD and cardiac safety, as well as Clinical Trial Management in diverse therapeutic areas such as allergy, dermatology, gastroenterology, orthopedics, and women’s health. The company is recognized for integrity, reliability, and a strong focus on high-quality clinical research.
Role Description The Senior Clinical Research Associate (CRA) is a Remote role based in Florida, you will be responsible for monitoring and coordinating clinical trials to ensure compliance with protocols, Good Clinical Practice (GCP), and regulatory requirements. This role includes performing site qualification, initiation, monitoring, and close-out visits; reviewing source documents and case report forms for accuracy and completeness; and verifying informed consent and patient eligibility. The Senior CRA collaborates with investigators, site staff, and internal clinical operations teams, providing guidance on study procedures and resolving site issues. Daily activities also involve tracking study progress, managing essential documents, supporting safety reporting, and contributing to risk assessment and quality improvement initiatives across assigned studies.
Essential Responsibilities
- Strong expertise in clinical trial protocols, including protocol interpretation, implementation, and adherence.
- Extensive experience as a Clinical Research Associate, with proven ability to independently monitor and manage clinical trial sites.
- Solid understanding of clinical trials and clinical operations, including GCP, ICH guidelines, and applicable regulatory requirements.
- Verify CRF’s with source documentation.
- Track SAE’s reporting at Investigator Sites.
- Excellent organizational, time management, and communication skills, with the ability to collaborate effectively with cross-functional teams and site personnel.
- Proficiency with electronic data capture (EDC) systems, CTMS, and standard office software; familiarity with risk-based monitoring approaches is beneficial.
Qualifications
- Remote must live in the Dade, Broward or West Palm Beach areas of Florida.
- Bilingual-Spanish speaking required.
- Bachelor's Degree and a minimum of 3 years operating at a Senior CRA level or equivalent training and education.
- Valid Drivers License is required
- Ability to travel 80% and may include international travel.
- Accreditation as a Clinical Research Associate (ACRP or SOCRA) preferred
