Overview

UBC Forest & Conservation Sciences Department Research Asst/Tech 4 Part Time in Vancouver, BC

UBC Forest & Conservation Sciences Department

Branch Vancouver BC CA

Position:
Research Asst/Tech 4
Location:
Vancouver, BC

Coordinating and participating in meetings with pharmaceuticals, consultants, and CROs for trial initiation, monitoring of patients visits and study close-out…

This is a 50% FTE part-time position (days to be determined). The research assistant will participate in the Pulmonary Hypertension research program with responsibilities directly related to assisting the study coordinators administrating clinical trials in pulmonary hypertension and related laboratory responsibilities.

Organizational Status

The incumbent will report to the clinical trials physicians (Drs. Swiston, Levy and Brunner) and coordinator of the pulmonary hypertension clinic.

Work Performed

Under broad direction of the PI, this position performs the following duties:
– Planning and developing recruitment strategies, coordinating and conducting patient recruitment, identifying, screening, bookings and enrolling suitable patients into studies.
– Assist in the planning, organizing and delivery of multiple concurrent clinical trials in accordance with study requirements and Good Clinical Practice (GCP). This includes assisting with budget development; writing/implementing study protocols; and communicating and coordinating clinical trial activity with representatives on PI’s behalf.
– Developing Standard Operating Procedures and implementing study protocol. This includes designing and developing data collection methodologies and databases.
– Developing tools to aid in protocol implementation including creating source documents, checklists, case report forms and test worksheets.
– Creating, maintaining, collecting, coding and entering research data into paper and electronic Case Report Form programs.
– Reviewing data results and provide recommendations to PI based on results. Resolving any data related queries.
– Identifying and submitting to local Research Ethics Board (REB) protocol deviations
– Collecting patient blood samples via venipuncture and other human specimens as required and processing and shipping of samples according to the Transportation of Dangerous Goods guidelines.
– Acting as a key liaison with Principal Investigator (PI) and sponsors.
– Managing study supplies, maintains inventory and is accountable to the PI, sponsor and federal regulatory bodies as per Good Clinical Practice guidelines.
– Coordinating and participating in meetings with pharmaceuticals, consultants, and CROs for trial initiation, monitoring of patients visits and study close-out visits.
– Coordinating research subject treatment with various departments, physicians and other study staff personnel
– Informing the investigator of the clinical progress of the study subjects
– Transmitting study data to sponsors including micro transmission.
– Performing ECG testing including ones on special machines provided by sponsors.
– Ensuring CT scan data, Echocardiogram and ECG data is transferred to sponsor according to study protocol.
– Performing specific tests including the 6 minute walk test according to study protocol.
– Participating in developing and evaluating strategies to meet the clinical trial goals and objectives and ensuring enrolment expectations are met.
– Carrying out research functions including checking and verifying patient history and medication use; obtaining records from patients’ family physician, hospital or laboratory as required;
– Informing investigator and sponsor of any Serious Adverse Events to patients during the trial.
– Obtaining appropriate related data and follow up on Serious Adverse Events.
– Providing patient education on study background, purpose, procedures and potential benefits and risks.
– Ensuring appropriate notification to family physicians and/or specialists of patient’s participation and of any change in patient’s condition or abnormal test results and action taken by PI.
– Training patients on the use of new research devices including new inhalers according to study procedures and electronic diaries. Responds to and answers patient questions, concerns, and problems.
– Training staff to perform specific tests pertaining to clinical trials and train back-up study coordinators.
– Coordinating the scheduling of patient appointments as per study requirements.
– Conducting the close out of the study ensuring proper storage according to regulatory requirements.
– Participating in the review of new studies including completing site selection questionnaires provided by new sponsors
– Attending investigator meetings, teleconferences, educational sessions and specific certification to make the site more attractive to sponsors.
– Providing leadership and guidance in resolving patient related issues as appropriate including to study sponsors, patients and site teams (PI’s, nurses, booking clerks, etc).
– Reimbursing patients for minor expenses and preparing cheque requisitions for payment for subjects’ compensation. This includes reimbursing for study related services such as lab tests, pulmonary function testing, X-Rays, cardiac catheterizations, CT scan, pathology and echocardiograms. Prepare travel reimbursement forms for research staff.
– Meeting deadlines for industry sponsors.
– Communicating and coordinating study activity with nursing staff, VGH laboratory staff, Pulmonary Function laboratory staff , Cardiac Lab staff, Pathology, Echo staff and Pharmacy staff.
– Administering oral study medication under supervision of PI and/or supplies appropriately as per study protocol. Provides patient education on appropriate use and storage.
– Carrying out functions outlined in the study protocol(s) such as assessing vital signs and collecting blood samples.
– Maintaining calibration records of study equipment and if needed schedule servicing and re-calibration of equipment.
– Managing research financial accounts via UBC FMS system and VCH accounts
– Facilitating catering for monthly rounds meeting in the Pulmonary Hypertension clinic.
– Administers various study related questionnaires to patients.

Supervision Received

This position will perform duties independently under the broad directives and supervision of the PI.

Supervision Given

None

Consequence of Error/Judgement

Works within well-defined guidelines and procedures, but is expected to exercise considerable initiative and judgment in establishing priorities, and carrying tasks through to completion. New or unusual problems would be referred to the study coordinator. Errors in this position would potentially result in incorrect data being collected on a particular study patient when related to error in form preparation or incorrect blood preparation and shipping. Subject records are highly confidential. Lack of careful attention to regulatory guidelines and approvals could suspend Investigator/physician and hospital/University as a site for further clinical research and/or funding. Clinical mistakes made by the coordinator could be potentially affect safety of the subjects. PI relies on the coordinator to alert them to clinical problems and unexpected events concerning study subject and trial conduct. Failure to do so may result in patient’s safety being jeopardized.

Qualifications

Undergraduate degree in a relevant discipline or Graduation from a technical college or institute. Minimum of 4 years of related experience or the equivalent combination of education and experience. Previous experience in clinical drug trials, computer skills, medical terminology. Previous experience in conducting clinical trials, experience in venipuncture. Self-directed and has the ability to exercise judgment and initiative. Team-oriented, committed and precise. Demonstrates responsibility and accountability. Good organizational and communication skills. Deal with a diversity of people in a calm, courteous and effective manner. Maintain accuracy and attention to detail. Ability to prioritize work effectively to meet deadlines. Work effectively independently and in a team environment. Ability to communicate effectively verbally and in writing. Ability to exercise tact, discretion and diplomacy. Ability to analyze problems, identify key information issues and effectively resolve the situation.

UBC hires on the basis of merit and is strongly committed to equity and diversity within its community. We especially welcome applications from visible minority group members, women, Aboriginal persons, persons with disabilities, persons of minority sexual orientations and gender identities, and others with the skills and knowledge to productively engage with diverse communities. All qualified candidates are encouraged to apply; however Canadians and permanent residents will be given priority.

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Employment Type: Part Time
Location: Vancouver, BC, CA
Posted on: 2016-09-21
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