About Company
Career.zycto is a dynamic force in advancing medical knowledge, committed to excellence in clinical research. We pride ourselves on fostering an environment where precision, innovation, and ethical conduct converge to deliver groundbreaking results. For a clinical research documentation associate, our firm offers unparalleled opportunities to contribute to critical health studies, ensuring data integrity and regulatory compliance. Join a team dedicated to making a tangible impact on global health outcomes, where your meticulous attention to detail and organizational prowess are highly valued and directly fuel scientific progress. Here, your work isn’t just a task; it’s a vital part of discovery.
Job Description
Are you a meticulous and detail-oriented professional with a passion for scientific accuracy and regulatory compliance? Career.zycto is seeking a dedicated Clinical Research Documentation Associate to join our growing team in Downtown Sudbury. In this critical role, you will be instrumental in maintaining the integrity and quality of our clinical trial documentation, ensuring all records meet stringent regulatory requirements and internal standards. This is a fantastic opportunity to contribute directly to groundbreaking research that impacts global health, working within a supportive and innovative environment.
As a Clinical Research Documentation Associate, you will be at the heart of our operations, managing essential trial documents from study initiation through archival. Your keen eye for detail will ensure that all paperwork, electronic records, and data entries are precisely organized, complete, and readily accessible for audits and reviews. You will collaborate closely with study coordinators, investigators, and quality assurance teams, providing expert support in document control processes. This role demands a proactive individual who thrives in a structured setting, understands the importance of confidentiality, and is committed to upholding the highest standards of Good Clinical Practice (GCP). Join us and become a pivotal part of a team dedicated to advancing medical science and improving patient lives through rigorous, ethical research.
Key Responsibilities
- Manage, organize, and maintain all essential clinical trial documents (e.g., Investigator Site Files, Trial Master Files, Electronic Trial Master Files) in accordance with GCP, regulatory guidelines, and company SOPs.
- Perform meticulous quality control checks on documentation to ensure completeness, accuracy, and compliance with all relevant standards.
- Assist in the preparation for internal and external audits, including regulatory inspections, by efficiently retrieving and presenting requested documentation.
- Collaborate effectively with study teams to ensure timely submission, proper filing, and version control of all required study documents.
- Track and reconcile document submissions, proactively identifying and resolving any discrepancies or missing information.
- Support the systematic archival of study documents upon trial completion, ensuring long-term accessibility, integrity, and regulatory adherence.
- Provide comprehensive training and ongoing guidance to new team members on document management best practices, systems, and company procedures.
- Contribute to the continuous improvement of departmental Standard Operating Procedures (SOPs) related to documentation and records management.
Required Skills
- Bachelor's degree in a life science, healthcare, or a closely related scientific field.
- Minimum of 1.5 years of experience in clinical research, with a significant focus on document management or data coordination.
- Strong understanding of Good Clinical Practice (GCP) and relevant regulatory requirements (e.g., Health Canada, FDA).
- Exceptional organizational skills, a keen eye for detail, and a commitment to accuracy.
- Proficiency in electronic document management systems (EDMS) and advanced knowledge of Microsoft Office Suite (Word, Excel, PowerPoint).
- Excellent written and verbal communication skills for effective collaboration and documentation.
- Ability to work both independently with minimal supervision and as an integral part of a collaborative team.
- Proven ability to manage multiple tasks, prioritize effectively, and meet deadlines in a dynamic, fast-paced environment.
Preferred Qualifications
- Certification in Clinical Research (e.g., CCRP, CCRC).
- Experience with specific Trial Master File (TMF) or electronic Trial Master File (eTMF) systems (e.g., Veeva Vault eTMF, MasterControl).
- Familiarity with medical terminology and a basic understanding of clinical trial phases.
- Experience in a variety of therapeutic areas or with different types of clinical studies.
Perks & Benefits
- Competitive salary and a comprehensive benefits package, including health, dental, and vision coverage.
- Opportunities for continuous professional development, training, and clear career growth pathways.
- A collaborative, supportive, and innovative work environment that values every team member's contribution.
- The chance to make a direct and tangible impact on significant medical advancements and patient care.
- Access to a modern office space located in the vibrant heart of Downtown Sudbury.
- Generous paid time off, including vacation days and statutory holidays.
- Participation in employee wellness programs designed to support your overall health and well-being.
How to Apply
Ready to contribute your expertise to a team that’s making a real difference in healthcare? We encourage all qualified candidates to apply promptly. Please click on the application link below to submit your resume and a cover letter detailing your relevant experience and why you are the ideal candidate for this pivotal role at Career.zycto. We look forward to reviewing your application!
