Research Assistant/Tech 3

Jobinhalt

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

• Report to the Director and Program Manager of the program.
• Recognize and maintain confidential information.
• Ensure that all aspects of study are performed within International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and Tri-Council guidelines.
• Ensure compliance with institutional Standard Operating Procedures (SOPs) for clinical trials conduct.
• Review, become knowledgeable about, and adhere to clinical research protocols.
• Develop informed consent forms in consultation with PI, sponsor and REB.
• Prepare REB and regulatory submissions.
• Submit relevant documents to REB, sponsors and regulatory bodies.
• Correspond with PI, sponsors, REB, regulatory agencies as needed and document all correspondence in a clear, concise and timely fashion
• 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.
• Develop excellent study specific work files and document information precisely.
• 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.
• Develop study advertisement, promotional material and teaching material for study subject recruitment and conduct.
• Communicate study procedures to physicians, clinical and research personnel, and provide updates and support to other staff when required.
• Work with administrative staff to ensure each study is conducted efficiently and in a fiscally responsible manner.
• Coordinate with radiology, laboratory, pharmacy, health records, and nursing as needed by specific protocols.
• Prepare for and participate in sponsor site visits, regular monitoring visits and study conference calls.
• Report adverse events promptly and accurately as specified in study protocol
• Ensure appropriate study close-out, including archiving and document storage and security.
• Complete time sheets and study tracking logs required for fiscal monitoring of study resource utilization.
• Screen hospital charts for potential study participants and be able to discuss eligibility with coordinators and physicians.
• Participate in screening, consenting, enrollment, and participants’ study follow-up.
• Perform study specific assessments, including vitals, phlebotomy, ECG monitoring.
• Conduct study questionnaires and performs assessments, review medical charts fo r past medical history and current medications.
• Perform da ta entry in a timely and accurate manner.
• Provide administrative support including filing, directing phone calls, updating tracking logs and maintaining trial regulatory documents.
• Prepare and organize materials (e.g. documents, lab kits) for ongoing patient follow up study visits.
• Organize, prioritize and respond appropriately to incoming correspondence.
• Prepare documents, blood samples and other materials for proper handling and shipping.
• Work effectively with research coordinators and manager to ensure effective and efficient study conduct.
• Perform other research tasks and provides research support as directed.
  
  

Education/Work Experience

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

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.
• 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.
• 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.
• 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.
• 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.
  
  

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.