Clinical Research Nurse

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Job End Date

Note: Applications will be accepted until 11:59 PM on the Posting End Date.

At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career. 

Job Summary
The Clinical Research Nurse supports clinical research activities for the Division of Cardiology in the Department of Medicine, coordinating and delivering high-quality cardiac research studies in accordance with regulatory, ethical, and clinical standards. The role involves patient recruitment and consent, study coordination, and data collection, while working closely with investigators, multidisciplinary clinical teams, and academic and industry research partners. The Clinical Research Nurse ensures participant safety, protocol adherence, and accurate documentation, and contributes to the advancement of evidence-based cardiovascular care.  
Organizational Status
This position works under the supervision of Principal Investigators within the Division of Cardiology and Research Manager.  Collaborates with researchers, coordinators, and hospital staff to ensure that study-related tasks are completed.
Work Performed

• Develops and supervises implementation of clinical trials.
• Develops and promotes activities relating to research and multi-centre clinical trials locally and internationally.
• Designs and develops data collection methodologies, instruments and databases.
• Oversees and coordinates data and specimen transfer.
• Conducts preliminary data analysis on study data bases.
• Generates progress and interim reports for presentation.
• Prepares and follows up on initiatives or issues relating to research and clinical trials.
• A key liaison with research manager, Principal Investigator (PI) and sponsors.
• Provides leadership in all areas of research and clinical trials in the hospital and community.
• Participates in developing and evaluating strategies to meet the clinical trial goals and objectives.
• Reviews and implements research protocol.
• Preparation of study documents including ethical submissions, regulatory documents and hospital research approvals.
• Assists in clinical trial budgets.
• Participates in identifying and applying for additional funding.
• Facilitates participation of medical students and physicians in training.
• Teaches and provides leadership to staff in associated areas within the hospital regarding the study purpose, goals, objectives and requirements.
• Independently evaluates eligible patients for study entry.
• Obtains and documents patient informed consent as per GCP(Good Clinical Practice).
• Manages study supplies, devices and drugs, is accountable to the Investigator, sponsor, federal regulatory bodies as per Good Clinical Practice guidelines.
• Provides patient education as per study protocol.
• Identifies, problem-solves, monitors and assesses subjects for adverse events and adherence to protocol under direction of the Investigator.
• Informs investigator, sponsor and UBC Clinical Research Ethics Board of any Serious Adverse Events to patients during the trial.
• Obtains appropriate related study data including blood samples & ECG’s, hemodynamic measurements, and angiographic records.
• Case management of ongoing follow-up assessment including history, physical exam, venipuncture, ECG, Doppler ultrasound and other diagnostic tests and counseling of outpatients.
• Completes and corrects study records and case report forms independently or in consultation with the sponsor and/or their representative
• Oversees completion and confidentiality of the study including audits by sponsor and/or regulatory authority.
• Responsible for the overall conduct of the studies and as per Good Clinical Practice.
• Ensures subject safety, regulatory compliance and enrollment expectations are met.
• Meets deadlines for academic and industry sponsors.
• Functions as a resource with hospital staff, patients and colleagues
• Supervises nurses and technologists who are involved with the study conduct or patients.
• Supervises patient progress and follow-up within study protocols and communicates to Investigator.
• Attends sponsor Investigator meetings and study education sessions.
• Attends education sessions related to clinical and regulatory updates, and professional development.
• Attends off hours on-call duty and availability to come to the hospital.
• Performs other duties as required.
  

Consequence of Error/Judgement
The Clinical Research Nurse is responsible for: 

a) Clinical mistakes made by the Clinical Research Nurse could be life threatening to patients. Ensuring patient safety includes:

                 -  accurately judging study eligibility

                 -  updating clinical skills and knowledge to meet the demands of clinical complexity    

b) 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.The performance of clinical trials and research projects must strictly conform to appropriate regulations:

      -  personal: maintaining professional behavior and respect for patients and staff

      -  local: the UBC Clinical Research Ethics Board, Good Clinical Practice

      -  provincial: B.C. Privacy Act

      -  federal: Health Canada, International Conference on Harmonization, Tri-Council Policy Statement                                                

      -  international: U.S. Federal Code of Regulations (FDA), Declaration of Helsinki

In addition, the Research Manager and Principal Investigators rely on the Clinical Research Nurse to alert them to clinical problems and unexpected events concerning study patients and trial conduct.

c) 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.
Supervision Received
The Clinical Research Nurse reports to the Research Manager and Principal Investigators within the Division of Cardiology. Since the conduct of a trial may involve working independently, the incumbent is responsible to apprise the Research Manager and Principal Investigators of any important communication or events.
Supervision Given
The Clinical Research Nurse acts as a resource with hospital staff, patents and colleagues; directs research assistant and clerical staff; and follows patient progress and discharge. Delegated tasks include, organizing study documents.
Minimum Qualifications
Registered Nurse with BCCNP plus a minimum of one year of nursing 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

Preferred Qualifications

• Strong computer skills including Word, Excel and electronic communications.
• Effective oral and written communication, supervisory, problem solving, interpersonal, multi-tasking and excellent organization.
• Demonstrates responsibility and accountability.
• Cardiac research experience is an asset.
• Is self-directed and has the ability to exercise judgment and initiative, team-oriented, committed and precise.
• The Clinical Research Nurse is expected to work collaboratively as part of a team with other clinical research coordinators, hospital staff, attending physicians, support staff, grant and industry sponsors and their representatives, regulatory agents and clinical investigators.
• Performs as a critical thinker and has the ability to operationalize a protocol into a functional study.
• Demonstrates ability to work effectively and precisely under pressure and time constraint (accuracy and attention to detail required).