Clinical Research Assistant

**Position title: Clinical Research Assistant**

**Status: Temporary Full Time**

**Classification: SRI appropriate - Grant Funded**

**Program: Neuroscience Program**

**Platform: Physical Sciences**

**Reporting to: Nir Lipsman**

**BASIC FUNCTION: The individual will have reporting responsibilities to Dr. Nir Lipsman, Director **for **Harquail Centre for Neuromodulation, and the Manager, Clinical Trials, Oncology platform. The key responsibilities will involve supporting patient recruitment, timely and accurate data entry as well as general coordination of Focused ultrasound (FUS) trials within the Harquail Centre for Neuromodulation at Sunnybrook Research Institute. *This is an on-site role.**

**About Harquail Centre for Neuromodulation (HCN), at Sunnybrook Research Institute (SRI)**
- Focused Ultrasound is a non-invasive, image guided surgical modality that can be used to lesion deep brain targets or open the blood brain barrier in various brain-based disorders to potentially deliver therapeutics
- Researchers at SRI have the largest and most comprehensive experience with animal models of FUS and one of the world’s leading experience in clinical use of FUS
- SRI has published the world’s first experience with FUS and various disorders of the brain

**JOB RESPONSIBILITIES**

**Primary responsibilities will include, but not be limited to, the following**:

- Engage in all aspects of data entry, query resolution and follow-through
- Support team members in preparation for site monitoring visits or potential audits by assisting with completion of electronic and paper case report forms (clinical notes, treatment reports and trial charts)
- Maintain required study related records including paper and electronic case report forms, clinical records, and/or regulatory forms
- Assist with regulatory maintenance including tracking of Investigator CVs, training logs, medical licenses, protocol amendment updates, study accountability logs etc.
- Support all aspects of clinical trial coordination support in study start-up through completion, organizing protocol study visits and related study activities
- Liaise with Study Managers and SHSC/SRI personnel internally and externally to maintain efficient procedure flow
- Assist in study recruitment by reviewing patient charts/clinical notes against study inclusion/exclusion criteria
- Ensure compliance with protocols and with relevant regulatory and institutional polices
- Assist in scheduling study visits and assessments, coordinates with internal staff and investigators as well as communicate appointments to the patient and/or their legal guardian(s)
- Detailed understanding of all Oncology protocols and procedure requirements
- Assist with patient flow during treatment days, support trial patients by navigating them through the hospital during study visits
- Support team’s knowledge translation and publication efforts with writing, literature reviews, and data processing as requested by Harquail Centre investigators
- Provide coverage where required for other platforms (neurodegenerative, psychiatry, movement disorders)
- Assist in organizing/updating study invoices, expenditure and accounts where required
- Support procurement of study specific clinical and lab materials for trial execution
- General administrative and lab event support as requested

**ESSENTIAL QUALIFICATIONS**
- Bachelor’s degree, Applied Health Sciences preferred
- Experience with Good Clinical Practice, clinical research trials, coordination & electronic data capture databases preferred
- Strong interpersonal, time management, organizational skills and attention to detail required
- Previous experience in Oncology an asset
- Experience with pharmacy nomenclature, medical terminology preferred
- Familiarity with Research Ethics Board submissions is an asset
- Training in Biosafety, WHMIS, and Occupational Health and Safety regulations.
- Working knowledge of general-purpose computer software (including, but not limited to Excel, MS Word, Power point)
- Ability to set priorities and manage time successfully to coordinate workflow around deadlines and shifting priorities

In addition, you will be expected to:

- Work within the larger context of Hospital and Research Institute rules and regulations, policies, procedures, practices, safety procedures and current legislation, in particular the Human Rights Code regarding discrimination and harassment.
- Ensure the confidentiality of patient, employee and Hospital information at all times.
- Work cooperatively and constructively with the other members of staff.
- Perform the above functions in a manner which reflects Sunnybrook Health Sciences Hospital & Sunnybrook Research Institute philosophy and mission of service, while promoting and maintaining good public relations with patients, visitors and staff.

**We would like to thank all applicants, but only those selected for an interview will be contacted.**

Sunnybrook Research Institute is co