Job Description
Job Summary:
In accordance with the Purpose, Vision, Values, Coast Salish Teachings, and strategic direction of PHSA, safety, including both patient and employee safety, is a priority and a responsibility shared by everyone at PHSA. As such, the requirement to continuously improve quality and safety is inherent in all aspects of this position. For a specific trial or project, the Clinical Research and Trials Coordinator (CRTC) receives direction from the Qualified Investigator/Principal Investigator, Manager, or designate to perform and organize special work assignments and projects.
The CRTC participates as a part of an interdisciplinary team and is responsible for the coordination of clinical trial activities to ensure that the objectives of the clinical trial are met. The CRTC organizes special projects related to the clinical trial, drafts grant applications for review, and, in collaboration with the Clinical Trials team, maintains research activities, determines the data requirements and coordinates the data capture activities of the clinical trial. In collaboration with the Qualified Investigator/Principal Investigator, Manager, or designate, the CRTC assists with preparing documentation required for ethics review and organizes relevant material required for internal and external audits and inspections.
The CRTC collects, analyses, and interprets data for a variety of research activities, including resource requirements, and providing updates to the Qualified Investigator/Principal Investigator, Manager or designate. The CRTC assists in pilot study design and funding applications to various granting bodies and writes status reports for grant funders and sponsors.
Duties/Accountabilities: 1. Coordinates, organizes and performs special work assignments and projects, including chart reviews, database development and surveys, to ensure the objectives of the assignments/projects are met as directed by the Qualified Investigator/Principal Investigator, Manager or designate.
2. Participates in preparing grant applications to a variety of internal opportunities and external grant funding agencies by coordinating meetings with investigators, drafting the application, researching literature that outline the objective and background, methodology and evaluation criteria of the trial to be approved by Qualified Investigator/Principal Investigator and Clinical Trial Team.
3. Maintains a clinical research program directory, requests regular updates from Principal Investigators for existing entries and adds new study entries.
4. Prepares, organizes and maintains clinical trial research activities and assists the Qualified Investigator/Principal Investigator, Manager or designate with financial tasks for trials or research studies in collaboration with the Clinical Trials Unit.
5. Responds to research cancer patient referrals, connects with patients by phone or in-person to assess their consent status, and consents patients for research studies.
6. In collaboration with the Clinical Trials Team, determines the data requirements for specific projects, coordinates the data capture activities and captures the clinical trials data according to the study protocol or project specifications.
7. Assists in the planning of pilot studies, in consultation with the Qualified Investigator/Principal Investigator, Manager or designate, by providing information to assist in the determination of study feasibility, including issues related to possible study costs, time requirements, resource implications, quality of data and ease of data capture.
8. In collaboration with the Qualified Investigator/Principal Investigator, Manager or designate, completes and submits documents for BC Cancer Research Ethics Board review and maintains ongoing ethics-approved research protocols as required by the BC Cancer Research Ethics Board. Submits adverse event reports, amendments, annual renewals and general correspondence as required.
9. In collaboration with the Qualified Investigator/Principal Investigator, Manager or designate, plans and prepares for internal and external audits or inspections by performing duties such as organizing clinical charts, data summaries and regulatory material for review as required by the study Sponsors and auditors. Assists in addressing any deficiencies and responding to audit recommendations.
10. Maintains knowledge of current developments in research studies through activities including reviewing relevant literature, consulting with other professionals and attending relevant education programs as requested and approved by the Qualified Investigator/Principal Investigator, Manager or designate. Conducts medical literature searches and literature reviews as required. Prepares a variety of reports for the Qualified Investigator/Principal Investigator, Manager or designate.
11. Recommends new applications and procedures to the Qualified Investigator/Principal Investigator, Manager or designate which could contribute to the improvement of processes and/or productivity to the Clinical Trials Unit or Clinical Research Program.
12. Promotes research studies to patients, families and health care professionals, updates webpage, shares information in newsletters.
13. Performs other related duties as assigned.
Qualifications: Education, Training and Experience
- Graduation from a recognized Bachelor of Science program such as Biology or Physiology.
- A minimum of one year of recent related experience including experience coordinating a research project in an academic or health care setting or an equivalent combination of education, training and experience.
Skills and Abilities
- Demonstrated relevant clinical research knowledge.
- Demonstrated ability to perform data capture, management, retrieval and analysis using an automated information system.
- Demonstrated ability to deal with others effectively.
- Demonstrated computer skills including the ability to work in an intermediate Microsoft Office environment utilizing a wide variety of software
- Demonstrated ability to work efficiently with a high degree of accuracy and attention to detail.
- Demonstrated ability to work independently and prioritize work.
- Demonstrated ability to multi-task in a busy clinical / translational research environment.
- Demonstrated interpersonal skills, including the ability to communicate effectively, orally and in writing, with all levels of staff.
- Demonstrated ability to operate related equipment.
- Physical ability to perform the duties of the position.
- Demonstrated skills in CPR techniques.
Job Tags
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