Job Description

Clinical Trials Assistant




About Queen's University

Queen's University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and many more.


We are committed to employment equity and diversity in the workplace and welcome applications from individuals from equity seeking groups such as women, racialized/visible minorities, Indigenous/Aboriginal peoples, persons with a disability, persons who identify in the LGBTQ+ community and others who reflect the diversity of Canadian society.


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Job Summary

Reporting to the Team Lead, the Clinical Trial Assistant (CTA) is responsible for administration within a trial team and provides support for communication and meetings, trial coordination and conduct, data management and quality, as well as other key activities. Working within a collaborative team-based structure the CTA supports the conduct of national, international, cooperative oncology group, multi-centre, clinical trials in cancer therapy, prevention, and supportive care. Understands general clinical trials research principles, regulations and guidelines, and adheres to Group Standard Operating Procedures (SOPs) and Work Instructions (WKIs). CTAs ensure accurate and efficient trial conduct and coordination through collaboration with other CTAs, trial team members, and CCTG staff as required. CTAs facilitate network engagement through support of participating centres as well as network members and external partners.

KEY RESPONSIBILITIES:

Administration

- The Clinical Trial Assistant (CTA) is the key individual responsible for administration in a trial team environment. This includes organizing and maintaining components of the trial master file, centre files, correspondence, and other documentation in an electronic environment.


- Provides expertise in document management and formatting in compliance with CCTG requirements.


- Maintains trial websites including coordination of collection and dissemination of confidential trial information.




Communication & Meetings

- As the first point of contact from participating centres and other external partners, builds and maintains relationships with key network stakeholders. Leads response to inquiries received or determines the need to re-direct inquiries that are trial or medically focused as appropriate.


- Proactively participates in timely management of key trial milestones including site activation or data locks. Prepares communications including but not limited to newsletters.


- Provides meeting support to trial teams and disease site committees using in-person and online formats and tools as required. Holds proficiencies in the use of meeting platforms and current technology (e.g. Zoom, Teams). Assists with preparation of agendas, correspondence, and drafts minutes. g Creates other materials for meetings if requested.




Trial Coordination and Conduct

- In partnership with the Study Coordinator, monitors the trial (central and local) activation process to ensure key administrative steps have been completed and milestones are met. Identifies any risks or challenges to ensure they are resolved promptly to facilitate the activation process.


- Maintains activation checklists and leads drafting of activation documents for review by the Study Coordinator.




Data Management and Data Quality

- Holds expertise in the use of computer systems and applications in clinical trials conduct (Mango, OPEN, Oracle, and EDC - Medidata Rave and REDcap). Accurately processes patient registration/randomization and incoming data in a time-sensitive manner.


- Creates guidance documents for logistics of patient enrolment. In partnership with the Study Coordinator, during database development, supports formatting of mock case report forms for posting and distribution.


- Supports oversight of data and query progress including form submission and query resolution processes to ensure quality. During data review and analysis, supports investigation and resolution of data submission and query resolution issues noted. Additionally, assists with complex logistics of platform trials (e.g. master protocol and patient matching steps) and supports CCTG-wide database maintenance and/or trial conduct activities (e.g. Electronic Data Capture Lab Database, data tracking to ensure provision of funding to Participating Centres)




Trial Master File

- Supports trial master file development at trial initiation and throughout the trial to ensure accuracy and compliance. Completes quality assurance checks, identifies gaps, and reviews issues identified with the Study Coordinator/trial team. Follows up to ensure resolution of outstanding and/or inaccurate TMF content. Completes final quality assurance check prior to TMF transfer to external partners.


- Privacy standards: Reviews de-identified supporting documents collected centrally to ensure compliance with applicable regulations and guidelines to ensure privacy according to CCTG SOPs, WKIs, and processes. Completes quality assurance checks, triages all documents received, and identifies those that require further follow up for national and international clinical trials.




Correlative Science Activities

- Supports clinical trial requirements for correlative science including liaising on behalf of the trial team with the Tumor Tissue Data Repository to ensure the required correlative kits are distributed to participating centres/groups. Assists with kit production if required.


- Conducts reconciliation on samples collected throughout the trial to ensure all is received for analysis.


- Contributes to the development and maintenance of central resources including SOPs, WKIs, templates, and standard documents.


- Demonstrate commitment to fostering a diverse, equitable and inclusive environment, and contribute to meeting and event processes that are respectful and collaborative.


- Undertake additional duties as assigned related to trial operations or CCTG Group deliverables.

REQUIRED QUALIFICATIONS:

- Post-Secondary education in office administration in a medical / health related area or other relevant discipline.


- Minimum 3-5 years of administrative experience in a research / medical setting.


- Knowledge of clinical trials, oncology and medical and scientific terminology would be considered assets.


- Consideration will be given to an equivalent combination of education and experience.

SPECIAL SKILLS:

- Strong attention to detail and accuracy, thorough when performing tasks and conscientious about attending to details.


- Excellent time management and highly effective organizational/administrative skills to deal with volume of work and conflicting priorities, ensuring deadlines are met and trial documentation is appropriately organized and filed. Ability to work under pressure and prioritize effectively.


- Sound knowledge of office procedures including filing systems.


- Ability to work effectively both independently and as part of a team-based structure.


- Ability to prioritize competing demands.


- Strong customer focus: ability to meet the needs of internal and external contacts professionally and effectively with a proven ability to establish and maintain effective working relationships with others.


- Strong task-oriented work ethic, work to tight deadlines.


- Diplomacy, tact, and good judgement, and the ability to deal with issues in a professional manner internal and external to the Group.


- Excellent interpersonal and communication skills.


- Excellent writing skills to draft correspondence. Highly proficient in the use of word processing, PowerPoint, spreadsheets, web authoring and database software as well as in-house applications. Ability to adapt readily to the implementation of new technologies.


- Ability/enthusiasm to learn new skills.

DECISION MAKING:

- Understand priorities of various tasks and schedule time to meet conflicting deadlines.


- Identify and bring forward issues that arise through meetings or daily interactions that need resolution or clarification by more senior staff.


- Handle and refer incoming correspondence and phone calls to the appropriate individual for follow-up, particularly those, which are, time or content sensitive.


- Respond to inquiries from cancer treatment centres or partners (e.g. Cancer Trial Support Unit) on administrative tasks (e.g. participant enrollments), understanding when additional information is required and when to involve other trial team members.


- Ongoing assessment of own workload priorities to integrate with trial priorities.


- Determine when questions would be more appropriately answered by the Study Coordinator or Senior Investigator.




Employment Equity and Accessibility Statement

The University invites applications from all qualified individuals. Queen's is strongly committed to employment equity, diversity, and inclusion in the workplace and encourages applications from Black, racialized persons, Indigenous people, women, persons with disabilities, and 2SLGBTQI+ persons. In accordance with Canadian Immigration requirements, priority will be given to those who are legally eligible to work in Canada.


The University provides support in its recruitment processes to all applicants who require accommodation due to a protected ground under the Ontario Human Rights Code, including those with disabilities. Candidates requiring accommodation during the recruitment process are asked to contact Human Resources at hradmin@queensu.ca.

Skills

Reference

432903