About Company
At Hiring.zycto, we believe in empowering our talent to make a tangible impact on global health. We are an innovative force in the clinical research landscape, committed to advancing groundbreaking therapies through rigorous and ethical trials. Our culture thrives on collaboration, continuous learning, and fostering an environment where every Senior Clinical Research Associate can excel, lead, and contribute meaningfully to patient outcomes. Join us to be part of a forward-thinking team dedicated to excellence and making a difference.
Job Description
Hiring.zycto is seeking a highly motivated and experienced Senior Clinical Research Associate (SCRA) to join our dynamic team. This is a remote position, offering the flexibility to work from your home office while contributing to cutting-edge clinical trials across various therapeutic areas. As a Senior CRA, you will play a pivotal role in ensuring the successful execution of clinical studies, adhering strictly to Good Clinical Practice (GCP) guidelines, standard operating procedures (SOPs), and regulatory requirements. You will be responsible for managing clinical sites independently, building strong relationships with investigators and site staff, and proactively identifying and resolving issues to maintain data integrity and patient safety.
This role demands a high level of autonomy, critical thinking, and advanced problem-solving skills. You will leverage your extensive experience in clinical monitoring to oversee all aspects of site performance, including site selection, initiation, routine monitoring, and close-out. Your responsibilities will extend beyond typical monitoring activities to include providing mentorship to junior CRAs, contributing to process improvement initiatives, and taking a leadership role in complex study issues. If you are passionate about clinical research, thrive in a remote work environment, and are eager to make a significant impact on the advancement of new treatments, we encourage you to apply. We offer a collaborative and supportive culture where your expertise is valued and your professional growth is actively supported.
Key Responsibilities
- Independently perform all types of monitoring visits (site selection, initiation, routine, and close-out) for assigned clinical sites, ensuring adherence to study protocols, GCP, SOPs, and regulatory requirements.
- Develop and maintain strong working relationships with investigators, site staff, and internal project teams, fostering effective communication and collaboration.
- Verify the accuracy, completeness, and consistency of clinical data entered into the electronic case report forms (eCRF) against source documents.
- Ensure timely and accurate data entry, query resolution, and reporting of adverse events (AEs) and serious adverse events (SAEs).
- Provide comprehensive training and ongoing support to site staff on protocol specifics, regulatory obligations, and study procedures.
- Proactively identify, address, and escalate site performance issues, compliance concerns, and data quality trends to relevant stakeholders.
- Participate in the review and development of study-related documents, including protocols, consent forms, and monitoring plans.
- Assist in the preparation for regulatory inspections and audits, ensuring all site documentation is inspection-ready.
- Mentor and provide guidance to less experienced CRAs, contributing to their professional development.
- Contribute to the development and implementation of process improvements within the clinical operations department.
Required Skills
- Minimum 5 years of independent clinical monitoring experience across multiple therapeutic areas.
- In-depth knowledge of ICH-GCP guidelines, Health Canada regulations, and other applicable regulatory requirements.
- Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC), and eTMF systems.
- Exceptional written and verbal communication skills, with the ability to articulate complex information clearly.
- Proven ability to work autonomously and manage multiple priorities effectively in a remote setting.
- Strong problem-solving and analytical abilities, with keen attention to detail.
- Demonstrated ability to build and maintain professional relationships with clinical sites.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Preferred Qualifications
- Bachelor's degree in a life science-related field or equivalent combination of education and experience.
- Experience in oncology, rare diseases, or central nervous system (CNS) therapeutic areas.
- Certification as a Clinical Research Associate (e.g., CCRP, CCRA).
- Experience with complex study designs or early phase clinical trials.
- Previous experience in mentoring or leading junior CRAs.
Perks & Benefits
- Competitive salary and comprehensive benefits package (health, dental, vision).
- Generous paid time off and holidays.
- Fully remote work model, providing ultimate flexibility and work-life balance.
- Opportunities for continuous professional development and career advancement.
- Supportive and collaborative team environment.
- Contribution to groundbreaking research that impacts patient lives.
- Reimbursement for home office setup and internet expenses.
How to Apply
Eager to make a significant impact in clinical research from the comfort of your home? Click on the application link below to submit your resume and cover letter. We look forward to reviewing your qualifications.