About the Role
Our client, a leading global biopharmaceutical company, is seeking a highly experienced Senior Clinical Research Associate (CRA) to remotely support their groundbreaking oncology clinical trials. This role is critical in ensuring the successful execution of studies that bring innovative cancer treatments to patients worldwide. The Senior CRA will be responsible for monitoring clinical trial sites, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This is a fully remote position, offering flexibility while requiring a high degree of self-discipline and proactive engagement. You will work with cutting-edge therapies and contribute to life-changing advancements in cancer care from anywhere in the world, with a specific focus on research relevant to populations potentially served by services in Limpopo , even though the role is remote.
Key Responsibilities
- Perform remote monitoring of clinical trial sites to ensure compliance with study protocols, SOPs, and regulatory requirements (e.g., FDA, EMA, ICH GCP).
- Ensure accurate, complete, and timely source data verification (SDV) through remote review of electronic health records and other study documents.
- Manage site relationships, providing training and ongoing support to investigators and site staff.
- Oversee site performance, identify potential issues, and implement corrective and preventative actions (CAPAs).
- Ensure timely drug accountability and regulatory documentation at study sites.
- Facilitate site initiation, interim monitoring visits, and site closure activities remotely.
- Prepare and present monitoring reports and participate in investigator meetings.
- Maintain comprehensive study documentation and ensure data integrity.
- Act as a key point of contact for sites, internal study teams, and external vendors.
Requirements
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- A minimum of 5 years of experience as a Clinical Research Associate (CRA), with a significant portion focused on oncology trials.
- Extensive knowledge of ICH GCP guidelines, clinical trial regulations, and monitoring processes.
- Proven experience with remote monitoring techniques and electronic data capture (EDC) systems.
- Strong understanding of oncology drug development and trial complexities.
- Excellent organizational, time management, and problem-solving skills.
- Exceptional communication, interpersonal, and negotiation skills.
- Ability to work independently, manage multiple priorities, and meet strict deadlines in a remote setting.
- Fluency in English is essential; proficiency in other languages is a plus.
Benefits
- This is a contract position offering a competitive hourly rate or project-based compensation.
- As a remote employee, you will have the flexibility to work from home.
- Our client provides opportunities for professional development, exposure to innovative clinical trials, and the chance to contribute significantly to oncology research.
- You will be part of a dynamic global team dedicated to improving patient outcomes through advanced clinical research.