About Company
Join Career.zycto and leverage your meticulous documentation skills in a vibrant remote environment. We empower clinical professionals to optimize data integrity and regulatory compliance, ensuring seamless operations across critical healthcare initiatives. This is an unparalleled opportunity for a Clinical Support Documentation specialist to thrive, contributing to vital projects from the comfort of their home. We foster a culture of precision, collaboration, and continuous learning, valuing your expertise in shaping the future of clinical data management within our innovative team.
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Job Description
The ‘Clinical Support Documentation – Remote’ role at Career.zycto is a crucial position for a detail-oriented professional passionate about accuracy and regulatory compliance within the clinical research and healthcare landscape. As a core member of our remote team, you will play an indispensable role in maintaining the integrity and accessibility of vital clinical documentation, directly contributing to the success of diverse medical projects. This fully remote opportunity allows you to apply your expertise from anywhere in Glendale, Red Deer, or surrounding areas, providing the flexibility and autonomy to manage your work-life balance effectively.
Your primary focus will be on the preparation, review, and maintenance of a wide array of clinical documents. This includes, but is not limited to, study protocols, informed consent forms, case report forms (CRFs), clinical study reports, and regulatory submissions. You will be instrumental in ensuring all documentation adheres to established standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and relevant regulatory requirements (e.g., Health Canada, FDA). This role demands a high degree of precision, a keen eye for detail, and a thorough understanding of medical terminology and clinical trial processes.
Beyond just managing documents, you will act as a key support system for clinical teams, facilitating smooth information flow and ensuring that all necessary paperwork is current, complete, and readily available for audits and inspections. This involves close collaboration with clinical research associates, study coordinators, data managers, and regulatory affairs specialists. You will be responsible for tracking document versions, archiving records, and utilizing electronic document management systems (EDMS) to their full potential. Your contribution will directly impact the efficiency and compliance of our clinical operations, ultimately helping bring new therapies and medical advancements to patients faster and more safely. We are looking for someone who thrives in a structured yet dynamic remote setting, can manage multiple tasks efficiently, and is committed to upholding the highest standards of clinical documentation excellence. This is more than a data entry role; it’s about being a guardian of critical clinical information.
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Key Responsibilities
- Prepare, review, and maintain clinical trial documents including protocols, informed consent forms, CRFs, and clinical study reports.
- Ensure all documentation complies with GCP, SOPs, and relevant regulatory guidelines (e.g., Health Canada, FDA).
- Utilize and manage electronic document management systems (EDMS) for document storage, retrieval, and version control.
- Collaborate with clinical research associates, data managers, and regulatory affairs teams to ensure documentation accuracy and completeness.
- Assist in the preparation for audits and regulatory inspections by ensuring all documentation is organized and readily accessible.
- Track and manage document lifecycles, including archiving and retrieval processes.
- Provide administrative support for clinical trials, focusing on documentation aspects.
- Identify and resolve documentation discrepancies in a timely and efficient manner.
- Contribute to the development and improvement of documentation processes and templates.
Required Skills
- Minimum 2 years of experience in clinical documentation, clinical research, or a related healthcare administrative role.
- Proficiency in medical terminology and understanding of clinical trial phases and processes.
- Excellent written and verbal communication skills in English.
- Demonstrated strong attention to detail and accuracy.
- Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Familiarity with electronic document management systems (EDMS).
- Ability to work independently and manage multiple tasks in a remote environment.
- Strong organizational and time management skills.
Preferred Qualifications
- Bachelor's degree in a scientific, healthcare, or related field.
- Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements (e.g., Health Canada, FDA).
- Experience with specific EDMS platforms (e.g., Veeva Vault, SharePoint).
- Certification in clinical research (e.g., ACRP, SoCRA).
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holidays.
- Flexible remote work schedule and location.
- Opportunities for professional development and continuous learning.
- Supportive and collaborative remote team environment.
- Contribution to impactful healthcare and clinical research projects.
How to Apply
To apply for this exciting remote opportunity, please click on the application link below. We look forward to reviewing your qualifications and learning how you can contribute to our team.
