Research Assistant/Tech 3 Jobs

Staff - Non Union
Job Category
Non Union Technicians and Research Assistants
Job Profile
Non Union Salaried - Research Assistant /Technician 3
Job Title
Research Assistant/Tech 3
Department
Hematology Research Program Support Division of Hematology| Department of Medicine | Faculty of Medicine
Compensation Range
$3,982.67 - $4,703.83 CAD Monthly
Posting End Date
June 10, 2023
Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.
Job End Date
Jul 31, 2024
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.
The Research Assistant will work with a team of research staff, administrative staff, physicians, and other healthcare professionals to carry out research activities. This position requires frequent contact with study participants and hospital staff. Clinical research is governed by regulatory and institutional guidelines and standards.
This position is located within a health-care facility. Therefore, this position requires successful verification of full vaccination against Covid-19 provided prior to the start date, as required by the provincial health mandate.
ORGANIZATION STATUS
The Division of Hematology at the University of British Columbia is seeking a Research Assistant for the Hematology Research Program (HRP). This program conducts phase I, II and III clinical trials as well as registries and other clinical research in patients with hematologic disorders. The HRP is located at Vancouver General Hospital (VGH).
DUTIES

• Perform study specific assessments, including vitals, phlebotomy, ECG monitoring.
• Participate in screening, consenting, enrollment, and participants' study follow-up.
• Perform other research tasks and provides research support as directed.
• Work with administrative staff to ensure each study is conducted efficiently and in a fiscally responsible manner.
• Prepare REB and regulatory submissions.
• Report adverse events promptly and accurately as specified in study protocol
• Prepare documents, blood samples and other materials for proper handling and shipping.
• Perform da ta entry in a timely and accurate manner.
• Develop informed consent forms in consultation with PI, sponsor and REB.
• Organize, prioritize and respond appropriately to incoming correspondence.
• Ensure appropriate study close-out, including archiving and document storage and security.
• Develop study advertisement, promotional material and teaching material for study subject recruitment and conduct.
• Complete time sheets and study tracking logs required for fiscal monitoring of study resource utilization.
• Report to the Director and Program Manager of the program.
• Prepare for and participate in sponsor site visits, regular monitoring visits and study conference calls.
• Correspond with PI, sponsors, REB, regulatory agencies as needed and document all correspondence in a clear, concise and timely fashion
• Review, become knowledgeable about, and adhere to clinical research protocols.
• Communicate study procedures to physicians, clinical and research personnel, and provide updates and support to other staff when required.
• Conduct study questionnaires and performs assessments, review medical charts fo r past medical history and current medications.
• Ensure compliance with institutional Standard Operating Procedures (SOPs) for clinical trials conduct.
• Develop excellent study specific work files and document information precisely.
• Ensure that all aspects of study are performed within International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and Tri-Council guidelines.
• Organize and prepare charts/case report forms/remote data entry for study monitor visits.
• Conduct daily aspects of the trials according to defined study protocols.
• Work effectively with research coordinators and manager to ensure effective and efficient study conduct.
• Maintain trial related documents in regulatory/study binder ensuring accuracy and completeness, including but not limited to source documentation, case report forms, certifications, screening logs, and drug accountability logs.
• Submit relevant documents to REB, sponsors and regulatory bodies.
• Screen hospital charts for potential study participants and be able to discuss eligibility with coordinators and physicians.
• Coordinate with radiology, laboratory, pharmacy, health records, and nursing as needed by specific protocols.
• Prepare and organize materials (e.g. documents, lab kits) for ongoing patient follow up study visits.
• Provide administrative support including filing, directing phone calls, updating tracking logs and maintaining trial regulatory documents.
• Recognize and maintain confidential information.

Education/Work Experience

• Some knowledge of medical terminology is an asset but not required.
• Excellent organizational, communication (oral and written English) and interpersonal skills.
• Enrolled in a science program (health sciences preferred).
• Working knowledge of Microsoft Office software (Word, Excel and Power point) required.
• Good attention to detail.

CONSEQUENCES OF ERROR
The Research Assistant should understand that:

• As a delegate of the qualified investigator, the assistant warrants that his/her performance in the conduct of clinical trials and research projects will strictly conform to appropriate regulations: 1) maintaining professional behaviour and respect for study subjects and staff; 2) the UBC Clinical Research Ethics Board 3) B.C. Privacy Act; 4) Health Canada, International Conference on Harmonization, Tri-Council Policy Statement, Good Clinical Practice; and 5) U.S. Food & Drug Administration.
• Poor communication skills could jeopardize study subjects' participation and continuation in studies, and could reflect badly on the research group and the University with sponsors and referring/community physicians.
• Lack of careful attention to regulatory guidelines and approvals can lead to suspension of further clinical research and/or funding for the investigator/physician as well as the hospital and University.
• Clinical mistakes made by the coordinator could be life threatening to subjects. Ensuring study 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.
• Lack of careful attention to regulatory guidelines and approvals can lead to suspension of further clinical research and/or funding for the investigator/physician as well as the hospital and University.
• The qualified investigator relies on the assistant to alert him/her to problems and unexpected events concerning study subjects and trial conduct. These include, but are not limited to: 1) poor study enrolment; 2) failure to complete work according to deadlines, 3) unexpected or excessive workload or administrative hurdles; 4) additional or non-budgeted requests from sponsors; 5) recurrent problem or concerns raised by clinical staff.

SUPERVISION RECEIVED
The Research Assistant will work under the supervision of the Director and Program Manager of the Hematology Research
Program and principal investigators (PI) to fulfill research-related responsibilities in a professional and ethical manner.
SUPERVISION GIVEN
None.
Minimum Qualifications
Completion of a relevant technical program or a university degree in a relevant discipline and a minimum three years of related experience or an equivalent combination of education and experience.
Ability to effectively use Microsoft Office software (Word, Excel and Power point). Excellent organizational and interpersonal skills.
Ability to communicate effectively verbally and in writing. Must demonstrate sound judgment, critical thinking, and logical decision-making.
Must possess strong problem solving skills, able to anticipate and resolve problems in a timely, effective, ethical, professional, and constructive manner. Must show strong negotiation, conflict resolution and rapport-building skills.
Demonstrated ability to take initiative and work in a team environment as well as independently with minimal supervision.
Ability to be flexible, multitask and work well under pressure in a fast-paced environment.
Ability to effectively work on multiple simultaneous projects and successfully prioritize to meet deadlines.
Self-directed, highly self-motivated, assertive, enthusiastic and honest in the performance of all duties.
Ability to work in a professional and ethical manner in accordance with hospital policies and procedures, and ICH/GCP guidelines. Must maintain competency in regulatory and institutional requirements to conduct clinical studies in human subjects (e.g. ICH/GCP guidelines, Tri-Council regulations).
Preferred Qualifications
Undergraduate degree in a health-related field (e.g. BSc, BScN, RN, LPN, pharmacy) and clinical research experience is preferred (other research experience will be considered).
Certification in venipuncture, Certification in transportation of dangerous goods, Certification with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA) is an asset. Medical terminology course/training is an asset.
Willingness to further professional knowledge through informal (e.g. reading journals/books) and formal education (e.g. attending rounds, conferences, training programs) preferred.