Job Summary & Requirements Clinical Research Associate

Position Summary:

Responsible for the following aspects of the Clinical Trials process including coordinating activities, monitoring of study compliance and maintenance of a system to ensure effective data flow, ensuring patient safety, study start-up procedures, consenting patients, monitoring patients on trials and toxicity assessment under direction of the principal investigator, maintaining and updating databases, ethics submission and ongoing regulatory monitoring and trial procedures.

Education:

I. 4 year Undergraduate Degree in Health Science

II. SOCRA Certification – preferred

Experience:

I. About 1 year

Competencies:

I. Demonstrated analytic, problem-solving and attention to detail skills

II. Documented expertise of provincial, national and international regulatory guidelines (e.g. PHIPA, PIPEDA, ICH-GCP, Tri-Council Policy Statement, etc.) is compulsory

Other:

III. Position has a level of accountability in that discussions/decisions regarding study documents are done with minimal to no supervision

IV. Ability to multitask and change priorities without supervision

V. Position generates many competing priorities

VI. Position requires excellent organization, time management, people skills, ability to communicate and collaborate with internal and external stakeholders

VII. Position is highly detail oriented

Clinical Trials Leadership

• Clinical informed consent process - provide informed consent to patient and discuss clinical trial with patient and family/friends
• Provide and discuss with trial patient(s) in follow-up phase of trial, any new published information regarding their protocol treatment, if it becomes available
• Ensure quality of life questionnaires are completed according to the protocol requirements.
• Assesses patient for toxicities. Documents toxicities with collaboration of 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
• 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 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 Clinical Trials 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
• Coordinate/communicate with Sponsors Study Managers, Research Associates, Research Ethics Boards, Monitors and Auditors throughout study duration (including closure and ongoing follow up)
• Lead Clinical Trials Meetings
• Monitoring visits, coordinating audits and all preparation and chart review, query resolution
• Provide back up for SAE reporting and sponsor follow up

Administrative

• Create Patient database by clinical trial
• Create workload databases as required
• Create reports from databases including Monthly Reports for Resource Nurse and Director/Coordinator
• CRF reporting in a timely manner, respond to data queries for external partners, and provide CTMS management keeping the system updated
• Maintain financial statistics for trials via spreadsheet and hard copy - liaise with Manager and Finance Department on a quarterly basis

Education

• Provide staff training and development as necessary to ensure maximum program effectiveness and in accordance with standard operating procedures
• Identifies and pursues own learning needs, attends in-services and site-specific conferences, participates in continuing education and/or oncology research-related professional activities
• Participates in orientation of new personnel and students as required
• Exhibits the core values of Royal Victoria Regional Health Centre: Work Together, Respect All, Think Big, Own It, Care