In addition to areas of the hospital, outpatient visits are performed in clinical offices, and research recording and communication occurs within the research office. Attendance at study meetings within the hospital, and travel to national/international conferences and study meetings occur several times a year.

Availability for some after-hours and week-end work required.

Responsible for setting goals in order to meet project deadlines in collaboration with the research team.

Responsible for writing local Investigator Sponsored Trial project proposals and ensuring the appropriate work plans and timelines are followed by the study team.

Providing expertise in the field of research processes and policies while working in collaboration with the Director.

Ensuring the research team (Coordinators & Nurses) are implementing study procedures in accordance with research protocols.

Screening and recruiting research subjects and devising strategies for effective recruitment.

Providing patient education on study background, purpose, procedures and potential benefits and risks. 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 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).

Creating and maintaining quality source documentation used for the collection of research dataEnsuring study conduct with adherence to ICH-GCP guidelines.

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.

Carrying out research functions including checking subject history, conducting interviews, completing questionnaires, making observations and assessing subjects.

Informing the Research Director, investigator and sponsor of any Serious Adverse Events to 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 and ensuring Health Canada regulations are met. 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) Hematology Clinical Trials staff and nursing 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.

Regulatory Activities:

Exercises professional judgment in regulatory conduct of research activities, and ensuring the Hematology Research & Clinical Trials Unit strict adherence to local, national and international regulations on how to conduct clinical trials (PIPA, PIPEDA, ICH/GCP).

Prepares study startup documents including regulatory requirements for sponsors and ethical approvals. Prepares study amendments and ensures updated study renewals; communicates with the UBC Clinical Research Ethics Board.

Other tasks:

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, research involving human subjects and trial related training. Performing other related duties as required to meet study goals and timelines.

b) Clinical mistakes made by the coordinator could be life threatening to subjects. Ensuring subject safety includes: 1) accurately judging study eligibility 2) being prepared for any side effects (expected or unexpected) and 3) updating clinical skills and knowledge to meet the demands of clinical complexity.

In addition, the Research Manager and PI rely on the coordinator to alert them to clinical problems and unexpected events concerning study subjects and trial conduct: 1) Lack of study enrollment and completion of work according to deadlines would threaten loss of funding and consideration for future invitations to participate in clinical trials and 2) Poor communication skills with subjects would jeopardize their participation, and with sponsors and referring/community physicians would reflect badly on the reputation of the research group.