JOB FACT SHEET POSITION INFORMATION Position Number: 14592 Current Grade (if applicable): 8 Working Title: Research Study Coordinator Faculty/Department: Department of Surgery, Division of Cardiac Surgery Department ID: Click here to enter text. Incumbent Name (if applicable): Click here to enter text. Campus Address: Click here to enter text. Campus Phone Number: Click here to enter text. E-Mail Address: Click here to enter text. Hours of Work/Week: Choose an item. Actual Hours Worked (if Part-Time): Click here to enter text. Name of Supervisor: Click here to enter text. Title of Supervisor: Click here to enter text. Supervisor’s Phone Number: Click here to enter text. Supervisor’s Email Address: Click here to enter text. Position Type: Choose an item. If OTHER, please indicate Position Type: Click here to enter text. Special Requirements: Home Internet Access: Choose an item. Professional Accreditation: Choose an item. Conflict of Interest Disclosure: Choose an item. Second Language: Choose an item. SIGNATURES: The signatures below indicate that all parties have read and discussed the content of the JFS EFFECTIVE DATE (if different from date signed): Click here to enter a date. FINANCIAL AUTHORIZATION: ___________________ ________________________ __________________ Name Signature Date ___________________ ________________________ __________________ Name Signature Date ___________________ ________________________ __________________ Name Signature Date ___________________ ________________________ __________________ Name Signature Date INCUMBENT (if applicable): SUPERVISOR: DEPARTMENT HEAD/TRUSTHOLDER: JOB FACT SHEET|1 JOB FACT SHEET 1. SIGNIFICANT CHANGES SINCE LAST REVIEW N/A 2. POSITION SUMMARY As part of the Division of Cardiac Surgery's research initiatives, this position will assist with all industrysponsored clinical trials and investigator initiated studies within the Division of Cardiac Surgery, Department of Surgery. The position will be supervised by the Division's epidemiologist and the study investigators; all of whom are ultimately supervised by the Division Director, Cardiac Surgery. 3. RESPONSIBILITIES/ACTIVITIES: Group activities into categories and list in point form each duty performed until the major elements of the position are represented. Review each statement to ensure that it accurately describes what is done and briefly, how it is done. Please indicate the percentage of time spent on each of the major activities listed Participates in protocol management: reviews and adheres to multiple research protocols Assists investigators with the preparation of documents for ethics submission (consents, protocols, study progress updates, adverse events reporting) Reconciles research accounts; assists with accounts and prepares invoices for payment Assembles study specific source documents and prepares study binders to ensure regulatory documentation is maintained to meet study requirements Conducts screening and recruitment of potential study participants; including obtaining consent, performs study specific assessments pre- and post-operatively as required/appropriate Provides instruction/teaching to study participants regarding study participation, protocol requirements, follow- up schedule, the use of data collection tools Conducts patient follow-up, data collection, case report form (CRF) completion, study monitoring, data query resolution; promotes patient's adherence to the study and monitors patient safety in relation to study protocols Provides ongoing written and oral reporting with the University Health Ethics Research Office (HERO) and Northern Alberta Clinical Trials and Research Centre (NACTRC); investigators and industry sponsors Works with investigators to notify departments regarding study termination/compliance; ensures appropriate retention of study files/materials Conducts daily aspects of trials according to defined study protocols JOB FACT SHEET|2 JOB FACT SHEET 4. KNOWLEDGE: Identify the minimum formalized training/education and/or qualifications required to prepare an individual to be functional in the position. Post-secondary education of a Bachelor’s degree or less with up to 18 months to become functional in the role NACTRC research course an asset 5. INDEPENDENCE OF ACTION: Describe the initiative required, the creativity and original thought, and also the amount of direction and control received from the supervisor or standard practices and precedents. A. What types of decisions are made independently? Decision- making will be made in accordance with protocol and guidelines as dictated by the research study projects in progress through ongoing consultation with supervisors B. For what actions is it necessary to consult someone? Are approvals or instructions verbal or in writing? Deviations from study protocol, patient compliance, concerns with patient adherence and safety within the study; adverse events need to be discussed with study investigator(s) 6. CONSEQUENCE OF ERRORS: Identify the extent of losses which result from mistakes in judgment or poor decisions (typical instances, not rare or extreme ones), and the responsibility for safety of others. One of the most important roles of a study coordinator is data integrity. A common error is incomplete or incorrect data entry which impacts the quality and integrity of the study, which in turn could impact continued funding support if the study sponsor/s chooses to withdraw from the study site 7. CONTACTS: Identify the contacts and the purpose of the interaction. A. Inside the University University of Alberta Faculty and staff Funding sponsors Study participants/ patients Alberta Health Services employees JOB FACT SHEET|3 JOB FACT SHEET B. Outside the University Funding sponsors Industry representatives Study participants/ patients C. Information Sources Multiple sources as required and appropriate to meet the responsibilities of the position 8. SUPERVISION: If this position is not required to supervise staff, please indicate “n/a”. A. Describe all aspects of formal supervision required of this position. Please be sure to complete Part B. N/A B. Please indicate how many staff members are supervised by the position. Full-time employees: N/A Part-time employees: N/A Casual employees: N/A 9. PHYSICAL DEMANDS: Describe the degree, frequency, severity, intensity and continuity of physical activity and/or intense visual concentration required. A. Activities There will be a requirement to spend a portion of most days in the preadmission clinic screening patients, coordination between surgeons’ and study investigators' offices, and follow- up clinics. B. What types of equipment or tools are used in the job? Computers 10. WORKING CONDITIONS: Describe the disagreeable aspects of the job environment in relation to employee safety and comfort, and the severity and frequency of exposure to workplace hazards. Standard office environment Primarily in the University of Alberta Hospital and the Mazankowski Alberta Heart Institute. The candidate may be required to wear scrubs and present in the operating room for the purposes of observation only, dependent on the study JOB FACT SHEET|4 JOB FACT SHEET 11. SIMILAR POSITIONS AT THE UNIVERSITY OF ALBERTA: Please list any position numbers, titles, departments or incumbent names that may be considered to be similar. This is a common position throughout the Faculty of Medicine & Dentistry; particularly within the Departments of Anaesthesia and Cardiology. 12. ORGANIZATION CHART: An organization chart is mandatory for the evaluation process to be completed. You may include this as a separate attachment or file may be pasted/ embedded below JOB FACT SHEET|5