Clinical Research Coordinator

University of British Columbia•Vancouver, BC

6d•CA$5,526 - CA$7,941•Onsite

About The Position

Responsible for planning, organizing, implementing and coordinating the activities of clinical research projects for the Multiple Sclerosis (MS) and Neuromyelitis Optica (NMO) Clinical Trials Group. Responds as required to the informational needs of potential subjects, health care workers, and the public regarding MS and NMO research.

Requirements

Undergraduate degree in a relevant discipline.
Minimum of two 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.

Nice To Haves

Knowledge of current research regulatory guidelines (ICH-GCP, Health Canada Div. 5, research involving human subjects) and standards is preferred.
Experience with psychometric testing and knowledge of standard neuropsychological tests required.
Working knowledge of research methodology and design.
Ability to exercise judgement and make decisions in accordance with the broad research objectives.
Ability to independently organize workload.
Computer proficiency mandatory, including use of Word and Excel spreadsheets and similar applications.
Knowledge of statistical methods and database applications is an asset.
Effective interpersonal, oral and written communication, organization and problem-solving skills.
Ability to maintain accuracy and attention to detail and to work effectively under pressure to meet deadlines.
Ability to work both independently and within a team environment.
Ability to exercise tact, discretion and diplomacy.
Availability for some after-hours and week-end work required.

Responsibilities

Implementing study procedures in accordance with research protocols.
Screening and recruiting research subjects and devises strategies for effective recruitment.
Providing patient education on study background, purpose, procedures and potential benefits and risks.
Conducting subject clinical, behavioral and neuropsychological assessments.
Training junior staff and/or student volunteers as required.
Preparing submissions to the Clinical Research Ethics Board.
Ensuring Accurate and timely data collection and response to study queries.
Organizing collection, storage and shipment of biomarkers in collaboration with Research Assistant/Tech. staff.
Organizing and prioritizes workload to meet the study deadlines and sponsor queries/requests.
Acting as a key liaison with Research Manager, Principal Investigator (PI), sponsors and Contract Research Organizations (CRO S).
Managing study supplies, maintaining inventory and is accountable to the Investigator, sponsor and federal regulatory bodies as per GCP guidelines.
Creating and maintaining quality documentation on research subjects: source documents, Case Report Forms (CRF/eCRF s), resolving queries in a timely manner.
Ensuring study conduct with adherence to ICH-GCP, FDA and Health Canada Div. 5 guidelines.
Informing the investigator of the clinical progress of the study subjects.
Meeting with pharmaceutical company representatives, consultants and Contract Research Organizations (CROs) for trial initiation, maintenance and monitoring of subjects visits.
Transmitting study data to sponsors with strict adherence to privacy and confidentiality guidelines (GCP).
Ensuring enrolment expectations are met.
Ensuring collection of appropriate subject samples including blood, urine and cerebrospinal fluid.
Assisting with health assessment report collection (bloodwork, MRI, Dermatology. Ophthalmology etc.).
Carrying out research functions including checking subject history, conducting interviews, completing questionnaires, making observations and assessing subjects.
Informing the Research Manager, Investigator, Research Ethics Board and sponsor of any Serious Adverse Events experienced by subjects during the trial.
Communicating regularly with the help desk teams of different sponsors to address technical problems on site or with study devices.
Responding to and answering subject questions, concerns, and problems (general study related questions [non-health related]).
Conducting the close out of the study ensuring proper storage according to regulatory requirements.
Monitoring subject progress: Identifies, problem-solves, monitors and assesses subjects for adverse events and adherence to protocol under direction of the Investigator.
Attending investigator meetings, teleconferences and education/workshop sessions.
Communicating and coordinating study related activity with (UBC and VGH) MS Clinical Trials staff, nursing staff, laboratory staff, pulmonary function, Pharmacy staff, and MRI staff.
Developing study source documentation to meet both study site and study protocol requirements.
Paying strict attention to detail, maintains a high level of organization and a strong commitment to meeting study timelines.
Traveling as required to attend meetings and conferences.
Assisting in subject recruitment for studies.
Acting as a blinded interviewer for studies as required.
Acting as a backup coordinator for other studies with other PIs when necessary.
Maintaining education and training on ICH-GCP, Health Canada Div. 5, research involving human subjects Standard Operating Procedures and trial related training.
Performing other related duties as required to meet study goals and timelines.