About Company
Okanagan Clinical Trials is a leading independent research site dedicated to advancing medical science and improving patient health through high-quality clinical research. Located in the beautiful Okanagan Valley, we partner with pharmaceutical companies and contract research organizations (CROs) to conduct trials across various therapeutic areas, including neurology, dermatology, and internal medicine. Our mission is to provide exceptional patient care while generating reliable data that contributes to the development of new treatments. We are a team of passionate professionals committed to scientific integrity, ethical conduct, and a collaborative work environment where every individual’s contribution is valued. Join us in making a significant impact on global health and scientific discovery.
Job Description
Are you a highly organized and detail-oriented professional with a passion for clinical research? Okanagan Clinical Trials is actively seeking a meticulous Clinical Research Documentation Associate to join our dynamic team in Lower Mission, Kelowna. This is an immediate hiring opportunity for an individual who thrives in a fast-paced environment and is dedicated to maintaining the highest standards of accuracy and compliance in clinical trial documentation.
In this pivotal role, you will be instrumental in ensuring the integrity and readiness of all study-related documents, forming the backbone of our research operations. You will manage, organize, and archive essential documents in accordance with stringent regulatory guidelines (ICH-GCP) and internal Standard Operating Procedures (SOPs). Your expertise will directly support our research coordinators, investigators, and quality assurance efforts, ensuring our trials meet stringent regulatory requirements and are prepared for audits. If you have a keen eye for detail, excellent organizational skills, and a commitment to quality, we invite you to contribute to groundbreaking medical advancements with us. This is more than just a job; it’s an opportunity to make a tangible impact on patient lives and the future of healthcare by ensuring the accuracy and compliance that underpin all successful clinical trials.
Key Responsibilities
- Manage and maintain Trial Master Files (TMF) and Investigator Site Files (ISF), ensuring completeness, accuracy, and compliance with ICH-GCP guidelines and SOPs.
- Perform rigorous quality control checks on study documents, including consent forms, source documents, regulatory submissions, and case report forms (CRFs).
- Assist in the preparation for internal and external audits and regulatory inspections, ensuring all documentation is audit-ready at all times.
- Administer electronic document management systems (EDMS), including uploading, categorizing, version control, and tracking documents.
- Facilitate the secure archiving of study documents at study completion, adhering strictly to retention policies and regulatory requirements.
- Support the research team with various administrative tasks related to clinical trial documentation and data management.
- Ensure timely and accurate input of data into relevant systems as required, maintaining data integrity.
- Communicate effectively and proactively with internal team members and external stakeholders regarding documentation status, requirements, and compliance.
Required Skills
- Minimum of 1 year of experience in a clinical research or highly regulated documentation role.
- Strong understanding of ICH-GCP guidelines and other relevant regulatory requirements.
- Exceptional attention to detail and superior organizational skills.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook) with advanced document formatting skills.
- Ability to manage multiple tasks, prioritize effectively, and meet deadlines in a dynamic, fast-paced environment.
- Excellent written and verbal communication skills, with a focus on clarity and accuracy.
- Demonstrated ability to work both independently and as part of a collaborative team, fostering a positive work environment.
Preferred Qualifications
- Diploma or Bachelor's degree in a scientific, health-related, or administrative field.
- Previous hands-on experience with electronic document management systems (EDMS) or eTMF systems.
- Familiarity with medical terminology and clinical trial processes.
- Experience in a Contract Research Organization (CRO) or pharmaceutical company setting.
- Knowledge of local and national clinical trial regulations beyond ICH-GCP.
Perks & Benefits
- Competitive salary and comprehensive benefits package (health, dental, vision, life insurance).
- Generous paid time off and observance of statutory holidays.
- Opportunities for continuous professional development, training, and continuing education.
- A supportive, collaborative, and innovative team environment committed to scientific excellence.
- The satisfaction of contributing to meaningful research that directly impacts global health and patient outcomes.
How to Apply
If you are a highly motivated individual eager to contribute to cutting-edge clinical research and ensure the highest standards of documentation integrity, we encourage you to apply today! Please click on the application link below to submit your resume and a detailed cover letter directly through our careers portal. We thank all applicants for their interest; however, only those selected for an interview will be contacted.