Senior Clinical Research Associate - Canada
Want to know company name or location? Company managed [?]
- Our company is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
- Our purpose as a company is to discover and develop therapies that will change the course of human health.
- We value our passion for patients, quest for innovation, spirit of independence and love of challenge.
- With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
- The Senior Clinical Research Associate will be responsible for monitoring assigned investigative sites to ensure subject safety and timely high quality data in compliance with regulations.
Responsibilities will include, but are not limited to, the following:
- Investigative Site Monitoring - Demonstrate a commitment to quality in all aspects of monitoring; adhere to study monitoring plans; conduct Pre-study Visits at Investigative Sites; conduct Study Initiation Visits at Investigative Sites; conduct Interim Monitoring Visits at Investigative Sites; review investigator study files and reconcile versus trial master files; perform investigational product accountability; conduct Close-out Visits at Investigative Sites
- Data Integrity - Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with study team in order to improve data quality; ensure issues of data quality are escalated and resolved with study team and CQA
- Subject Safety - Perform safety reviews/SAE reconciliations; monitor the informed consent process; ensure investigative sites’ adherence to GCP, ICH guidelines, and local regulations
- Train and Assist Investigative Sites - Attend Investigator Meetings; train investigative site personnel in GCP and ensure sites are conducting company clinical research according to the protocol, local regulatory requirements, and other appropriate regulations; serve as the liaison between our company and assigned sites; build relationships with site staff at assigned sites
- Communication - Identify site issues, ensure proper escalation, if necessary, and ensure resolution; create trip reports, confirmation/follow-up correspondence and telephone contacts for assigned sites; respond to audit findings; adhere to proper lines of communication within the company ; attend and participate in study team meetings; keep information in the CTMS current; maintain calendar
- Development - Maintain up-to-date medical and clinical knowledge for assigned therapeutic areas; mentor/coach new CRAs; maintain annual training records
- Corporate Goals - Identify/evaluate potential investigators for future company studies; build effective and positive relationships with Principal Investigators; ensure timely submission and review of CRF data and query resolution according to timelines set forth in the SMP; schedule travel following company’s travel policy, and submit expense reports in an accurate and timely manner
- Regulatory Documentation - Prepare ethics submissions and local regulatory documents at the country level, as needed; maintain local document files at a country level, as needed; review translations for ICD and other study documents, as needed; oversee to assure SOPs are followed in obtaining translations on necessary study documents
- Monitoring Lead (As assigned) - Serve on study team as monitoring representative; review RFPs regarding monitoring specifications; develop the study monitoring plan and subsequent revisions; review, track and acknowledge monitoring visit reports; manage and track monitoring site visits to ensure quality monitoring; ensure adequate monitoring resources; ensure monitors are trained properly in the study requirements; track and report critical issues to study team; participate in CRF and protocol review process; attend, participate and present at Investigator Meetings; perform field assessments of company and CRO FMs, as required; develop study-specific tools for Investigative sites and Field Monitors; conduct FM meetings; oversee CRO monitoring, as required.
- Significant medical and scientific knowledge
- Significant knowledge of Clinical Development Process
- Significant knowledge of monitoring
- Knowledge of regulatory environment and guidelines (ICH, GCP and CFR)
- Expert in a number of diseases, treatments, and compounds
- Significant knowledge of medical terminology
- Experience with developing study monitor plans
- Experience preparing for and presenting at investigator meetings
- Significant site management skills
- Ability to comprehend protocols and supportive information
- Excellent written and oral communication skills, including presentations
- Excellent relationship-building skills
- Ability to work in a cross-functional team environment
- Ability to work independently
- Proficient in writing function SOPS / Work Practices Demonstrated problem-solving skills
- Ability to resolve routine issues effectively and independently
- Organizational and time management skills
- Knowledge of MS Office
- Significant knowledge of Esystems (Inform, CTMS, etc)
- Ability to travel extensively within Canada including overnight stays (approximately 50%)
- Ability to drive an automobile and have a valid driver’s license
- Bilingual in English and French a requirement