Clinical Research Associate

Job Summary & Requirements

Position Summary:

Responsible for various aspects of multi-disciplinary Clinical Trials and research project coordination, including but not limited to organizing and planning of daily study activities, ongoing monitoring of study compliance, maintenance of data systems to ensure effective data flow, ensuring patient safety, coordinating all study start-up procedures, consenting patients, monitoring patients on trials, assisting with toxicity assessments under the direction of the principal investigator, maintaining and updating databases, research sample processing, coordination of shipment of dangerous goods in accordance with IATA, ethics submissions, and ongoing regulatory document management.

Qualifications:

Education:

• 4-year Undergraduate Degree in Health Science, or related field of study
• Previous clinical experience (an asset)
• SOCRA, or ACRP Certification – preferred
  
  

Experience:

• About 2 years
  
  

Competencies:

• Demonstrated analytic, problem-solving and attention to detail skills
• Documented expertise of provincial, national and international regulatory guidelines (e.g. PHIPA, PIPEDA, ICH-GCP, Tri-Council Policy Statement, etc.) is compulsory
  
  

Other:

• Position has a level of accountability in that discussions/decisions regarding study documents are done with minimal to no supervision
• Ability to multitask and change priorities without supervision
• Position generates many competing priorities
• Position requires excellent organization, time management, people skills, ability to communicate and collaborate with internal and external stakeholders
• Position is highly detail oriented
  
  

Responsibilities:

Regulatory and Ethics

• Coordinate and communicate with Sponsor, REB and Study team to initiate REB submissions for new clinical trials and research projects
• Prepare REB-related documents
• Prepare, submit and maintain study regulatory documents within specfic timelines
• Review the protocol and enter study information into research management databases
• Ensure all study documentation is completed accurately
• Prepare patients letters for family physicians
• Prepare annual study review documents
  
  

Clinical Trials Leadership

• Provide informed consent to patient(s) and discuss clinical trial, or research projects with patient, family/friends
• Provide and discuss with patient(s) in follow-up phase of trial/ research projects, any new published information regarding their protocol treatment, if it becomes available
• Ensure quality of life questionnaires are completed according to the protocol requirements.
• Assist with assessment of study patient(s) for toxicities. Document toxicities in collaboration with investigator and nurse and provides intervention for protocol medication, toxicities and patient care related to study as per protocol and as required
• Reports all adverse reactions according to protocol guidelines
• Acts as a resource for study patients regarding conduct of clinical trial/ research projects
• Ensures abstraction and recording of physical findings, laboratory data, and other details essential to the study on appropriate case report forms
• Understand the objectives of the clinical trials and research projects currently open to accrual, and demonstrates knowledge of all active and inactive protocols at the Centre
• Ensures quality assurance through accuracy and timeliness of submitted documentation and ensures that all data can be verified in the source document
• Maintains accurate data collection, through direct interviews with the protocol patients for the duration of the study, and coordinates the order of investigations and appointments according to protocol requirements
• Reviews research protocols to determine applicability, impact and accessibility in collaboration with Research team and multidisciplinary departments and Research Team .
• Contributes to others understanding and application of research and evidence based practice.
  
  

Coordination and Communication with Internal and External Stakeholders

• Facilitate the initiation, site visits, ongoing operation and closure of all new trials and research projects
• Coordinate/communicate with Sponsors Study Managers, Research Associates, Research Ethics Boards, Monitors and Auditors throughout study duration (including closure and ongoing follow up)
• Lead Research Meetings, and keep minutes.
• Coordinate Monitoring visits, audits, chart review, and query resolution
• Provide back up for SAE reporting and sponsor follow up
  
  

Administrative

• Manage REDCap database, and support creation of new studies in REDCap, assist internal and external researchers with REDCap project updates.
• Create patient and workload databases by clinical trial/ research project
• Create reports from databases including Monthly Reports for Research Supervisor, and Director
• Case report form management, and respond to data queries for internal and external partners
• Maintain all research management systems and keep system up to date
• Maintain financial statistics for trials, research projects and grants as applicable
  
  

Research Education

• Provide staff training and development as necessary
• Lead and coordinate site initiation visits
• Liaise with Clinical Educators to create training materials
• Identifies and pursues own learning needs, attends in-services and site- specific conferences, participates in continuing education and/or research-related professional activities across multiple disciplines.
• Participates in orientation of new personnel and students as required.
• Exhibits the core values of Royal Victoria Regional Health Centre: Team Up, Be Kind, Do Great Things, Inspire Trust, Be Bold