Position Summary:
The Research Assistant I supports Clinical Research Coordinators in the conduct of clinical trials to ensure adherence to study protocols, BioPharma Services Inc. (BPSI) Standard Operating Procedures (SOPs), International Conference on Harmonization – Good Clinical Practice (ICH-GCP) guidelines, and all applicable regulatory requirements. This role serves as a BPSI representative during monitoring visits and plays a key role in ensuring client and monitor satisfaction by assisting the Project Management team.
Duties and Responsibilities:
- Assist Clinical Research Coordinators with study-related tasks, including management and organization of source documents, binder preparation and filing, document archiving, Case Report Form (CRF) data entry, and administrative duties such as scanning and redacting source documents. Ensure timely and accurate preparation and maintenance of study source documents, including the creation of customized study-specific forms in both paper and electronic formats. Review source documents and templates (Study Source Document Templates [SSDTs] and CRFs) prepared by other Research Assistants to ensure quality and accuracy. Maintain records that are adequate, accurate, complete, and legible.
- Execute assigned clinic-related tasks in accordance with study protocols, SOPs, GCP guidelines, and regulatory requirements, ensuring timely and organized completion. Support Clinical Research Coordinators and the Medical Writing team with the maintenance of regulatory binders. Collaborate with Project Management and Data Management teams to meet key project achieve milestones and deadline
- Review clinical trial databases prior to activation (“go-live”) to ensure readiness and data base integrity.
- Perform data entry of safety laboratory results, electrocardiograms (ECGs), and any out-of-range laboratory values from screening, on-study, and post-study phases.
- Ensure scanned documents meet quality standards for data and archiving purposes.
- Coordinate and host study monitoring visits by preparing relevant documentation, booking meeting spaces, and liaising with monitors, clients, and internal departments to ensure expectations are met or exceeded.
- Participate in clinical meetings, training sessions, and other educational opportunities as required.
- Perform other clinic related duties as assigned, consistent wit training and experience.
Qualifications:
- College diploma in a science related discipline or equivalent.
- Certification in Clinical Research is considered an asset.
- Familiarity with ICH-GCP principles; previous experience in a Contract Research Organization (CRO) setting preferred. Ability to work flexible hours based on business needs. Strong interpersonal, communication and presentation skills.
- Excellent organizational and time-management skills with attention to detail, and effective problem-solving skills.
- Proficiency in MS Office (Word, Excel, PowerPoint, and MS Project).