This position has a term length of one year plus one day.
Location - This role is in-person. Work primarily takes place at North Campus, Edmonton.
The Clinical Research Coordinator is responsible for the day-to-day coordination and conduct of clinical trials and investigator-initiated research studies, from participant recruitment through study close-out. Working under the direction of the Principal Investigator, the coordinator recruits, consents and screens study participants, performs study-specific assessments, manages ongoing participant follow-up, and ensures all study activities are conducted in accordance with the approved protocol, International Council on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, National Institutes of Health (NIH) guidelines, and institutional policies. The coordinator maintains regulatory and study documentation, serves as the primary point of contact for study sponsors and monitors, coordinates with hospital departments including radiology, laboratory, pharmacy, health records and nursing, and maintains detailed time sheets allocating effort across studies. The position requires the ability to manage multiple concurrent protocols independently in a fast-paced clinical environment, and to work effectively with team members as the research program may grow in the future.
Responsibilities
Study Participant Management - 40%
- Identifies, recruits, consents and screens potential study participants against protocol-specific inclusion and exclusion criteria.
- Performs study-specific assessments as delegated by the Principal Investigator.
- Organizes and coordinates ongoing participant follow-up, including scheduling study visits and arranging laboratory work and procedures.
- Educates and advises participants regarding protocol requirements, study medications, treatment schedules, and the use of data collection tools.
- Identifies, documents and reports adverse events promptly and accurately in accordance with protocol and regulatory timelines.
Protocol, Regulatory and Data Management - 30%
- Reviews and develops working knowledge of assigned clinical research protocols and adheres to protocol requirements in all study activities.
- Maintains trial-related documents in the regulatory/study binder in an audit-ready state.
- Develops study-specific work files and documents study information precisely and contemporaneously.
- Organizes and prepares charts, case report forms and remote data entry in advance of study visits; completes data entry and resolves queries.
- Maintains the project/task management system and clinical trials management system (CTMS).
- Ensures all aspects of assigned studies are performed within ICH, GCP and NIH guidelines and institutional policy.
- Recognizes and safeguards confidential participant and study information.
Study Coordination and Communication - 20%
- Corresponds with study sponsors, contract research organizations and monitors.
- Participates in sponsor site initiation visits, routine monitoring visits, audits and study conference calls.
- Coordinates with radiology, laboratory, pharmacy, health records and nursing as required by specific protocols.
- Communicates study procedures to clinical and research personnel and provides ongoing in-servicing and support to other staff as required.
- Works with and delegates appropriate responsibilities to the study research assistant to keep multiple studies running efficiently.
- Travels to other study sites as required.
Administration and Professional Development - 10%
- Maintains detailed, accurate and up-to-date time sheets, including allocation of hours to specific studies, tasks and funding sources.
- Conducts the daily administrative aspects of assigned trials according to defined study protocols.
- Maintains professional knowledge through training programs and GCP/ICH refresher certification as necessary.
- Learns how to operate study equipment (e.g., ECG machine, spirometer).
Qualifications
- Undergraduate degree required. Other education combined with relevant clinical research experience will be considered. Patient interaction and clinical trials experience preferred.
- Minimum six (6) months of experience coordinating clinical trials or research studies, with demonstrated project management ability.
- Working knowledge of ICH Good Clinical Practice guidelines, NIH guidelines, and research ethics requirements; GCP/TCPS certification an asset (or willingness to obtain).
- Working knowledge of Microsoft Office (Word, Excel) and Google Workspace (Docs, Sheets) required.
- Technically capable, with willingness to learn and adapt to new technologies, and able to proficiently use required applications including online meeting, training, timesheet, project/task management, document management and CTMS platforms.
- Excellent organizational, oral and written communication, problem-solving and interpersonal skills in dealing with co-workers, clinicians and study participants.
- Demonstrated ability to take initiative and to work both in a team environment and independently with minimal supervision in a fast-paced setting.
- Ability to be flexible, multitask and work well under pressure; ability to coordinate simultaneous projects and prioritize competing tasks to meet deadlines.
- Self-directed, highly motivated, enthusiastic and honest in the performance of all responsibilities; able to work in a professional and ethical manner in accordance with hospital policies and procedures.
- Must be comfortable interacting directly with patients.
- Must possess a valid Alberta Class 5 (non-GDL) driver’s license.
- Must be able to provide a recent copy of a three-year driver’s abstract with no more than six (6) demerits and/or two (2) moving violations within the last two years.
- Own transportation, as travel to other sites may be necessary.
Application Instructions
Click “Apply Now” and submit the following documents:
- Resume
- Cover Letter
- ICH Good Clinical Practice E6(R3) Certificate (if available)
This position is subject to all applicable terms and conditions of the collective agreement between the Governors of the University of Alberta and the Non-Academic Staff Association (NASA).
This position offers a comprehensive benefits package.
The University of Alberta, its buildings, labs and research stations are primarily located on the territory of Néhiyaw (Cree), Niitsitapi (Blackfoot), Métis, Nakoda (Stoney), Dene, Haudenosaunee (Iroquois) and Anishinaabe (Ojibway/Saulteaux), lands that are now known as part of Treaties 6, 7 and 8 and homeland of the Métis. The University of Alberta respects the sovereignty, lands, histories, languages, knowledge systems and cultures of all First Nations, Métis, and Inuit.
The University of Alberta is a community of knowledge seekers, change makers and world shapers who lead with purpose each and every day. We are home to over 14,000 faculty and staff, more than 40,000 students and a growing community of 300,000 alumni worldwide.
Your work will have a meaningful influence on a fascinating cross-section of people - from our students and community members, to our renowned researchers and innovators, making discoveries and generating solutions that make the world healthier, safer, stronger and more just. Learn more.
At the University of Alberta, we are committed to creating an inclusive and accessible hiring process for all candidates. If you require accommodations to participate in the interview process, please let us know at the time of booking your interview and we will make every effort to accommodate your needs.
We thank all applicants for their interest; however, only those individuals selected for an interview will be contacted.
All University employees have a responsibility to foster a workplace that prioritizes safety in all its forms - physical, cultural, and psychological. This is achieved by promoting a safe environment, adhering to all safety laws, policies and procedures, completing all required safety training, identifying hazards and implementing controls, reporting incidents, and contributing to a culture of belonging and respect, while endeavoring to ensure that all colleagues feel valued and safe to express their thoughts, perspectives and concerns.
The University of Alberta is committed to creating a university community where everyone feels valued, barriers to success are removed, and thriving connections are fostered. We welcome applications from all qualified persons. We encourage women, First Nations, Métis and Inuit persons, members of visible minority groups, persons with disabilities, persons of any sexual orientation or gender identity and expression, and all those who may contribute to the further diversification of ideas and the University to apply.
L’Université de l’Alberta s’engage à créer une communauté universitaire où chaque personne se sent valorisée, où les obstacles à la réussite sont éliminés et où des connexions enrichissantes peuvent se développer. Nous accueillons les demandes de toutes les personnes qualifiées. Nous encourageons les femmes; Premières nations, Métis et Inuits; membres des groupes minoritaires visibles; personnes handicapées; personnes de toute orientation sexuelle ou identité et expression de genre; et toutes les personnes qui peuvent contribuer à la diversification des idées et à l'université à postuler.
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