Job Description

Staff - Non Union

Job Category M&P - AAPS

Job Profile AAPS Salaried - Research and Facilitation, Level B

Job Title Senior Research Coordinator-Pediatric Neurology

Department Connolly Laboratory | Department of Paediatrics | Faculty of Medicine

Compensation Range $5,468.83 - $7,878.17 CAD Monthly

The Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of the range is approximately halfway between the minimum and the maximum and represents an employee that possesses full job knowledge, qualifications and experience for the position. In the normal course, employees will be hired, transferred or promoted between the minimum and midpoint of the salary range for a job.

Posting End Date November 4, 2022

Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.

Job End Date Oct 31, 2023

This position is expected to be filled by promotion/reassignment and is included here to inform you of its vacancy at the University.

This position is located within a health-care facility, therefore, the successful candidate will be required to provide verification of full vaccination against Covid-19 provided prior to the start date, as required by a provincial health mandate.

This offer is conditional upon successful completion of a Criminal Record Check.

Summary
The primary focus of the Senior Research Coordinator is to carry out Research Ethics Board (REB) submissions, planning, coordination, implementation, clinical data collection, data management, query resolution, invoicing, financial oversight and communication duties associated with complex Phase 2 and Phase 3 multi-centre clinical trials sponsored mainly by the pharmaceutical industry in the Division of Pediatric Neurology. Exceptional organizational skills, as well as a high degree of motivation, enthusiasm, and initiative are required to provide coordination and management of 3 to 5 complex clinical trials in Pediatric Neurology research program.

Major responsibilities include acting as liaison within the sponsor, the CRO, and with the research community on behalf of the principal investigators. This position will also be responsible for drafting reports and other documentation for the sponsors; monitoring clinical trials budgets from initiation to end; timely invoicing, and ensuring payments from the CRO/sponsors are received on timely fashion. This position will build and foster effective working relationships with the sponsors/CROs, develop and maintain study documentation.

The position will provide support in confidentiality agreements (CDAs), contracts (CTAs), and quality assurance. Assistance in Health Canada and other regulatory agency interactions is also included in the duties. She will be responsible for administrating collaborative interactions of the Pediatric Neurology research group with industry sponsors, CROs, external research groups and collaborators. The position will provide administrative support for research activities of the PI mainly for clinical research.

The senior research coordinator will be allocated work space within the Division of Pediatric Neurology.

Organizational Status
Reports to the Neurosciences Program Research Director and the Principal Investigators. Works with the pediatric neurologists, research director, nurses, research coordinators, research assistants, students, statistical and computer consultants, and clerical staff.

Work Performed
Conducting complex clinical trials:
-Manages implementation of 3-5 complex clinical trials within the Division of Pediatric Neurology.
-Manages the protocol coordination, logistics and data management of all clinical trials.
-Coordinates multiple studies concurrently including study maintenance and wrap up.
-Ensures clinical trials will be conducted according to the highest legal, regulatory and ethical standards and Good Clinical Practice Guidelines (GCP).
-Plans and develops patient recruitment and retention strategies for varying clinical studies and trials.
-Coordinates the recruitment of suitable research project participants by performing duties such as contacting eligible participants, communicating research projects goals and processes to participants, explaining potential risks and possible benefits, answering participant questions and reviewing and witnessing consent forms.
-Develops communication strategies with families of enrolled patients.
-Provides participants with education/counseling where appropriate.
-Identifies and facilitates necessary partnerships and operational linkages with internal and external staff.
-Liaison with all hospital departments (Pharmacy, Cardiology, Radiology, Laboratory) involved in clinical trials for coordination of the study.
-Demonstrates communication and general behaviour which facilitates positive attitudes and trust by others involved in clinical research.
-Develops ethics applications for clinical research studies and clinical trials.
-Responsible for budget development, monitoring, and forecasting for sponsor and investigator initiated studies.
-Responsible for invoicing study related procedures per budgets indicated in study contracts.
-Monitors and assists the accuracy of study documents and related regulatory documents for studies per protocol and assesses what is needed to comply with protocol.
-Develops and implements tools to aid in protocol administration, protocol deviations and adverse events.
-Designs study-specific databases, data management systems and case report forms.
-Ensures that proper reporting of Adverse Events and Serious Adverse Events using the appropriate modes of communication and documentation is implemented.
-Provision of data to sponsoring and/or government agencies.
-Writes effective procedures and SOP s as required by the sponsoring agency.
-Provides detailed estimates of supplies needs prior to study implementation.
-Assesses staffing needs for studies and organizes training of professional staff (pharmacists, laboratory staff, back up coordinators, etc).
-Responsible for orientation and training of junior research staff and students in necessary techniques where applicable.
-Oversees the maintenance of appropriate regulatory documentation, CRF and source documents.
-Ensures proper storage of study documents, materials and laboratory kits as well as proper archiving.
-Meets with industry monitors.
-Attends weekly meetings with Research Director and Principal Investigators and provides rapport on the studies progress and any issues/problems.
-Prepares, drafts and edits presentation materials and attends meetings and conferences.
-Performs other study related duties.

Consequence of Error/Judgement
The Research coordinator is required to conduct all research activities in an ethical manner, suited to proper activities of the University of BC and to the professional organizations governing his or herself and those governing the activities of the Directors and all other investigators. Any procedures or data recorded as part of a trial must be accurate and must accurately reflect the work performed. Strict confidentiality of all study participants must be adhered to. All activities involving participants are accountable to the Principle Investigator, the Division Head, and the Research coordinator s governing professional organization.

Supervision Received
Most of the work will be done independently; however, the Principle Investigator(s) and the Research Director supervise all projects.

Supervision Given
The research coordinator will be responsible for the supervision of junior research staff and students participating in the student work program.

Minimum Qualifications
Undergraduate degree in a relevant discipline. Minimum of three years of related experience, or the equivalent combination of education and experience.

Preferred Qualifications
Skills:
-Computer knowledge with advanced skills in database development and statistics.
-Effective written and communication and interpersonal skills.
-Advanced organizational skills and ability to manage multiple projects at various stages of development and organization.
-Ability to build and maintain relationships with both clinical and technical staff.
-Ability to work both independently with minimal supervision. and in a team environment.