Senior Clinical Research Associate
Brunel
Mississauga, ON
Our pharmaceutical companies is seeking a Senior Clinical Research Associate with a Bachelor's Degree (or equivalent) with 6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience (3 to 5 years of local trial management experience).
The primary responsibilities of this role, Senior Clinical Research Associate are to:1. All aspects of site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites within the approved Clinical Development Plan . These global, complex studies are conducted within the standards set by the Global Development, according to Good Clinical Practices (ICH - GCP) and applicable regulatory and legal requirements;2. Managing Investigator site and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs;3. Managing Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out;
  • Conducting Site Selection Visits to confirm the Investigator and Site Staff are qualified, and have suitable resources and facilities to properly conduct the study;• Ensuring completion of site documents necessary for ethics and regulatory approval for site initiation within agreed upon timelines. Ensuring all legal, regulatory and client requirements are met prior to drug shipment to sites as well as all site initiation processes are completed;• Supporting the CLM to ensure the Investigator Agreements and budgets are negotiated and executed in a timely manner for assigned study sites;• Training and supervising cross functional site personnel on study related procedures for the duration of the study;
  • Continuously assessing site performance, processes, qualifications of staff, and suitability of facilities to ensure adherence to study protocol, client requirements, regulatory and local legal requirements, as well as ICH-GCP;• Tracking to ensure sufficient resources at site to conduct study activities for duration of the study;• Tracking enrollment activities to ensure site remains on track with site commitments. Develops contingency plans to ensure site commitments are met;• Reviewing patient data at site to ensure safety of patient and patient data is consistent with what is reported in the case report form. Serves as liaison between Investigator and Study Medical Expert to resolve any medical patient-related queries. The data from these clinical sites are required to demonstrate patient safety and efficacy of investigational products which forms the basis of regulatory approval and product labeling;
  • Assuring adequate control of investigational product (study medication), which includes: ensuring sites have met all local and legal requirements to receive investigational product, study drug storage, and continually ensuring patient compliance with expected study drug dosing. The CRA Level III is responsible for study drug accountability at the site level and arranges for destruction of investigational product in accordance with local legal and regulatory requirements;• Ensuring applicable authorities are notified of study closure and final patient status in accordance with ICH and local regulations.• Periodically reviews Investigator Site File to ensure essential documents are maintained according to ICH and SOP requirements.• Develop and implement strategies to engage and influence external stakeholders at all levels (Principle Investigators, Institution, Government) to develop the territories and establish positive, effective, efficient and competitive environment for clinical trials (cost effectiveness, recruitment strategies, speed of trials);
  • Develop strategic partnerships within their region to establish the client as a Sponsor of choice.
About you
Who are you The incumbent must have a Bachelor's Degree (or equivalent) with 6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience (3 to 5 years of local trial management experience);• The incumbent is responsible for site management and monitoring of applicable Phase I and all Phase II-IV complex and global clinical trials. This requires an in-depth knowledge of the drug development process and therapeutic area, including monitoring and site management, local and international regulations, ICH – GCP, drug safety requirements, data management processes and investigator grant parameters;
  • The position also requires awareness and understanding of cultural differences as well as regional operational differences and budget management;• Effective written and verbal English communication skills, strong oral presentation, strong motivation, negotiation, strategic and critical thinking, leadership, relationship management, interpersonal, decision-making and issue resolution skills (For CLM roles; leading and managing matrix team to align multi-discipline function to overall goals; project management of complex trials and processes);
The incumbent requires effective planning and organization skills, attention to detail and excellent follow through.

What we offer

Brunel Life Sciences provides global staffing, recruitment, and contracting solutions for Life Sciences, Pharmaceutical, Biotechnology and Healthcare organizations. Brunel Life Sciences plays a vital part of the Brunel International Group, with over 100 offices in 40 countries and approximately 13,000 employees around the globe.