Research Manager (Neurology)

University of British Columbia • Vancouver, BC

1d • CA$7,623 - CA$11,887 • Onsite

About The Position

This position is responsible for the start-up and initiation of clinical trials conducted at the Children's and Women's Health Centre of BC's Divisions of Neurology “The Division”. The Neurology Research program supports well over 100 active clinical research studies for children and young adults in British Columbia with neurological disorders. These studies include, but are not limited to, research on active treatment, innovative therapies and medical devices, supportive care, and the long-term effects of neurological diseases on quality of life. The primary function of the position is to contribute strategic vision to all research activities conducted within the Division and oversight to staff performing ethics and regulatory research activities, including start up and study maintenance, within the Division. The individual will be accountable along with the Research Director for the start up and execution of clinical protocols within the allocated budget, personnel resources and timelines. The incumbent is required to conduct all research activities in an ethical manner, suited to the regulations of the University of British Columbia and to the professional organizations governing them and those governing the activities of the institution and all other investigators. Any procedures undertaken as part of this position must follow applicable regulatory guidelines. Strict confidentiality of all study matters must be adhered to.

Requirements

• For research work, a post-graduate degree or equivalent professional designation with a minimum of four years of related experience, or an equivalent combination of education and experience.
• Otherwise, an undergraduate degree in a relevant discipline is required with a minimum of six years of related experience, or an equivalent combination of education and experience.
• Willingness to respect diverse perspectives, including perspectives in conflict with one’s own
• Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion
• Ability to work both independently and effectively manage a changing team environment
• Ability to motivate and lead a team with effective conflict resolution skills.
• Extensive experience with the UBC RISe application process or similar on-line applications
• Extensive knowledge of medical terminology
• Extensive knowledge of ethical principles and research applications
• Extensive knowledge of Canadian regulatory principles and legislation

Nice To Haves

• Demonstrated knowledge and experience with Pediatric Neurology and industry trials
• Attentive to detail, with the ability to work accurately and quickly
• High degree of computer literacy including familiarity with Microsoft Word and Excel
• Ability to learn new software programs
• Excellent organizational and interpersonal skills a must
• Ability to prioritize and work effectively under pressure to meet deadlines
• Ability to maintain relationships with both clinical and technical staff.
• Ability to exercise initiative and maintain confidentiality
• Effective communication, both orally and in writing

Responsibilities

• Reviews all potential industry-sponsored/funded studies for Neurology Program for operational feasibility and provides critical feedback to PIs.
• Ensures that proper procedures, agreements, and facilities are in place.
• Responsible for the overall management and support of study start-up; prioritization and assigning of work for all studies.
• Responsible for the hiring, oversight and evaluation of study staff and students collaboration with the Research Director.
• Manages the clinic trials start-up to ensure preparation, submission and maintenance of REB and departmental related documentation for a diverse number of protocols
• Manages the clinical trials start-up regarding the writing, preparation and amendments of ethics applications and other regulatory documents required by Health Canada and the FDA.
• Manages the clinical trials start-up ensuring that trials will be maintained according to legal and ethical requirements.
• Manage Research staff in the conduct of study activities
• Responsible for continuing quality improvement and quality assurance.
• Provides strategic leadership in the coordination and administration of the start-up activities of clinical trials to meet program objectives.
• Oversee and manage study specific meetings and participate in general staff training activities.
• Oversee and manage the research regulatory documents.
• Facilitates operational linkages within and among co-investigators, clinic directors, physicians and other health care professionals within the hospital and medical community.
• Ensures that there is up to date clinical trials start-up training to align with GCP (Good Clinical Practice).
• Responsible for protocol development for human clinical studies with local and external investigators.
• Over see and manage pre-study evaluations of clinical trial site and study specific site initiation visits (SIV) including coordination of visits, correspondence with sponsor/sponsors' representative(s), and addressing issues raised.
• Provide feedback on regulations and budget at study review meetings and throughout administration of clinical trials.
• Provide feedback on proposed study protocol issues.
• Liaise with the University/Industry Liaison Office (UILO), Technology Development Office (TDO) and BCCH Research Institute Finance Manager on contract related start-up and on-going issues.
• Liaises with co-investigators, collaborators, the health care team and other research personnel both on-site and at national/international institutions for: project management, information exchange regarding assigned studies, and logistics to facilitate the operation of the studies.
• Responsible for the organization and management of contracts and related communication between parties, budget reviews and negotiation, liaising with funding agencies/foundations, purchasing of equipment and supplies.
• Manage the activities surrounding monitoring and auditing by regulatory bodies for assigned protocols including coordination with research staff, preparing for and participating in visits, and responding to action-items that arise.
• Manage the activities surrounding the archiving of closed clinical research projects including trial file collection, organization, and storage by research staff and review to ensure compliance with regulatory standards.
• Attend conferences and meetings, possibly involving travel, and perform other related duties as required.
• Demonstrates communication and general behavior that facilitates positive attitudes toward participation in clinic research.
• Oversee and manage accuracy, accessibility, and confidentiality of study records and reports.

Benefits

• UBC supports inspired students, faculty and staff on their journey of discovery, and challenges them to realize their greatest potential.
• Recognized as a leading employer in British Columbia and Canada

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level