Clinical Research Core Manager

Job Category

Job Title

Department

Posting End Date

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

Job 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 Core Manager oversees the complex research, administrative, and operational aspects of large-scale, collaborative clinical research projects for the Division of Respiratory Medicine at the Centre for Heart Lung Innovation (HLI), St. Paul's Hospital, UBC. This role involves managing a team of project managers and study coordinators, ensuring the successful execution of study recruitment, data collection, and data management. The individual will be accountable for the execution of study protocols within the allocated budget, personnel resources and timelines. The individual will provide guidance to colleagues to ensure the successful achievement of study goals and milestones and maintain a high level of current knowledge in security, privacy and ethical arenas. Additionally, the Clinical Research Core Manager is responsible for the oversight of core finances, budgets, and the management of study personnel appointments.

Organizational Status

The UBC Centre for Heart Lung Innovation at St. Paul's Hospital brings together basic and clinician scientists in an exciting multidisciplinary environment to address heart, lung, and critical care disease. The HLI is the largest translational research centre within Providence Health Care's St. Paul's Hospital, comprised of 50 Principal Investigators (PIs) of which approximately 40% conduct clinical research and over 300 Scientists and staff. Education is provided to over 130 undergraduate, graduate, and post-graduate students.

The Clinical Research Core Manager will report to Dr. Janice Leung, the Medical Director of the Clinical Research Core, Claire Smits, the Operations Director at HLI, and to Dr. Don Sin, the Director of the HLI. The incumbent will work closely with UBC faculty members, program managers, study coordinators, ethics and finance officials, and clinical ancillary staff.

This position is based at HLI within St. Paul's Hospital, Division of Respiratory Medicine in a shared office environment.

Work Performed

• Leads clinical research team operations and supports Principal Investigators in the operational oversight of ~10 clinical research staff including:

  • Managing day-to day activities of HLI research projects related to SOP development and implementation, study participant enrollment, biospecimen collection, ethics and clinical data collection and monitoring

  • Develops resource manuals for research practices, policies and procedures for the Division of Respiratory Medicine;

  • Provides expertise in the field of research processes and policies while working in collaboration with the PIs

  • Responsible for training new staff on local standard operating procedures and ensuring all staff maintain a working knowledge of ICH-GCP guidelines

  • Establishes clear definitions of responsibility and education needs for members of the research team. Ensure all job descriptions within the area of responsibility clarify and delineate position expectations.

  • Implements study procedures in accordance with research protocols.

  • Providing organizational orientation and training specific to the clinical research activities of the Clinical Research Core and the job responsibilities of clinical research staff members (e.g., study recruitment, informed consent, data organization and management, participant follow-up, scheduling of tests);

  • Alongside the Research Scientists, participates in feedback regarding clinical team performance, facilitates professional development, advancement and training of research staff;

  • Support hiring of new clinical research staff, including Program Managers and Study Coordinators.

• Plans and implements research project designs, goals, and timelines;

• Manage finances and budgets of the Clinical Research Core. Prepares budget forecasts, budget estimates for grants, financial reports, and other required financial documents for accounts within HLI. Resolves any financial issues or problems that may arise. Reports routinely to PIs on financial status of the program and makes timely and supported requests for expenditures;

• Prepares study startup documents including regulatory requirements for sponsors and ethical approvals. Prepares study amendments and ensures updated study renewals; communicates with the UBC Clinical Research Ethics Board and supervises clinical research staff on regulatory and ethics board requirements.

• Facilitate contracts and data sharing agreements with sponsors and/or collaborating sites within Canada and Internationally;

• In collaboration with individual investigators, develops and manages research project timelines, ensures projects are implemented and delivered within specified timelines and work plans; monitor workflow and report on progress; develop, coordinate and implement/oversee data collection and study recruitment protocols.

• Provides advice and guidance to internal and external stakeholders on matters related to clinical research in the Division of Respiratory Medicine;

• Advises PI's in the conduction of research studies. This includes, but is not limited to, clinical trial approval process, study design, impact of research projects on program resource utilization, standard operational procedure development.

• Responsible for liaising with key stakeholders, responding to their information needs about the program, and preparing and disseminating key information

• Leads all Clinical Research Core meetings (research unit meetings and project-specific meetings);

• Advises and provides training on a variety of UBC policies and procedures to PIs, research team members and trainees;

• Oversees data collection and handling of subject records handling including: audit process, education and training records of study personnel and trainees;

• Ensures adherence to all safety standards, human ethics, and privacy protection guidelines across all research studies are met and maintained

• Ensures billing is completed on a monthly basis, with review of financial statement and follow up with Finance for delinquent accounts

• Seeks, develops, leads and monitors initiatives to promote equity, diversity and inclusion;

• Provides guidance and training regarding UBC/HLI financial procedures;

• Contributes to a respectful, inclusive working environment.

Consequence of Error/Judgement

This position exercises professional judgement and initiative in the management of various research activities and projects. Failure to plan or follow up on initiatives and poor judgment or errors would have an adverse effect on the research productivity and operational management of the projects. Failure to act in a professional, tactful manner would have an adverse effect on relations with various UBC and healthcare departments and relations.

Errors or incorrect decisions in ascertaining, interpreting, applying and communicating guidelines and policies could seriously compromise the quality of the research and result in delays in completing projects. Inability to complete work at a high level of accuracy and efficiency may adversely affect the quality and significance of the research and the reputation of the PIs. Activities such as database documentation of maintenance and access, research and support for both internal and external researchers are all critically dependent on the security and privacy of information systems that have been developed and are maintained. Any breach in confidentiality or data security would place the future of the research project at risk. Inadequate documentation, organization, communication, and planning may adversely affect the credibility and ability to secure future funding of investigators, staff and trainees.

Supervision Received

The Clinical Research Core Manager reports to Dr. Janice Leung, Claire Smits, and Dr. Don Sin. The incumbent works independently under general direction. The incumbent is expected to exercise sound judgement, take appropriate initiative, and is required to interact with faculty, researchers, systems analysts, and support staff in the Centre.

Supervision Given

The incumbent will be responsible to provide training, onboarding and supervision to the Clinical Research Core Team comprised of Program Managers and Study Coordinators.

Minimum Qualifications

Undergraduate degree in a relevant discipline. Minimum of three years of related experience, or the equivalent combination of education and 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

• Knowledge of quantitative research methods, implementation, and outcome assessment applicable to health and/or partnered research.

• Experience working with financial management.

• Ability to develop, implement and work with large clinical, research or administrative databases, specifically RedCap.

• Experience working in a health research environment preferred, ideally with respiratory patients.

• Experience with industry-sponsored clinical trials from study start up to close out, including regulatory aspects and Health Canada audits.

• Ability to effectively manage multiple assignments, and organize and prioritize workload under pressure to meet deadlines without compromising the quality of outcomes or accuracy of data.

• Excellent computer literacy (documents, presentations, spreadsheets, databases, statistics, analytics).

• Excellent interpersonal skills, along with the ability to work both independently and as part of an interdisciplinary team.

• Proven ability to lead teams and to promote teamwork, work collaboratively and build consensus with diverse groups.

• Ability to exercise judgment, tact, discretion, and diplomacy.

• Demonstrated problem-solving and analytical skills.

• Ability to communicate effectively and accurately, both verbally and in writing, in English.

• Ability to deal with a diversity of people in a calm, courteous, and effective manner.

• Ability to understand and apply policies, procedures, and instructions.

• Ability to occasionally adjust working hours to facilitate deadline-related work.