Clinical Research Coordinator

Socket.dev; Edmonton; On-site; CAD 60,000 - 80,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

The Clinical Research Coordinator (CRC/CRN) position is based in person at North Campus Edmonton and involves coordinating patient enrollment and study activities for ACURE research projects at Kipnes Urology Centre in collaboration with investigators and regulatory bodies.

The role balances administrative duties with direct patient-facing responsibilities, ensuring protocol adherence, data integrity and safety across multiple studies.

Qualifications

• BSc. or BScN. A combination of education and experience will be considered.
• Recognized certification in clinical research (ACRP or SOCRA) obtained or in progress is an asset.
• Previous clinical research experience
• Training in ICH/GCP guidelines and GCP Certificate an asset.
• Certification in Phlebotomy mandatory.
• NACTRC research course an asset.
• Proficiency with MS Office Software - Word and Excel required.
• Knowledge of IATA shipping regulations and basic laboratory procedures an asset.

Responsibilities

• Administrative Roles 50%: Plans and coordinates the initiation of research study protocols.
• Participates in protocol management, reviews and adheres to multiple research protocols.
• Reconciles research accounts, assists with accounts and prepares invoices for payment.
• Assembles study-specific source documents and prepares study binders to ensure regulatory documentation is maintained to meet the study requirements.
• Contributes to the development and maintenance of protocols, ethics applications, manuals, guidelines, SOPs, intake surveys, QoL questionnaires, and other study-associated documents.
• Provides ongoing written and oral reporting with the University Health Ethics Research Office (ARISE), Northern Alberta Clinical Trials and Research Centre (NACTRC), Human Research Ethics Board of Alberta (HREBA), investigators and industry sponsors.
• Works with investigators to notify departments of the study termination/compliance and ensures appropriate retention of study files/materials.
• Conducts daily aspects of trials according to defined study protocols.
• Monitors the progress of research activities, develops and maintains records of research activities, and prepares periodic and ad-hoc reports, as needed.
• Develops and implements quality control processes throughout the study.
• Establishes, executes, reviews and evaluates laboratory policies and procedures for operating functions, including manuals and SOPs, as well as manages all laboratory department’s activities.
• Provides access to laboratory personnel for consultation and determines operational troubles in timely manner.
• Monitors, orders and receives all study, lab and drug supplies, performs drug accountability and monitors expiry dates for all supplies.
• Performs quality assurance of medical lab equipment; orders, maintains and calibrates yearly.
• Maintains and updates WHMIS documentation and all other laboratory records, reports and files.
• Organizes the research lab to accommodate ongoing requirements and changing goals of the research department.
• Other miscellaneous tasks, such as supporting other programs, as assigned.
• Patient Facing Activities 50%: Provides instruction/teaching to study participants regarding participation, protocol requirements, follow-up schedule, and the use of data collection tools.
• Conducts patient recruitment, follow-up, data collection, case report form (CRF) completion, study monitoring, data query resolution, promotes patient’s adherence to the study and monitors patient safety in relation to the study protocols. Performs venipuncture to obtain blood samples, instructs patients to obtain urine or semen samples, requests, processes, stores tissue samples according to protocols and SOPs, and transfers samples to long-term storage facilities in a regular manner.
• Transfer samples to long-term storage facilities according to established SOPs.
• Instructs/collects/handles/transports urine, stone, implanted devices (catheters, stents etc.) from patients.

Skills

BSc or BScN

ACRP or SOCRA certification

Clinical research experience

ICH/GCP training

Phlebotomy certification

NACTRC course (asset)

MS Word and Excel proficiency

IATA shipping knowledge (asset)

Education

BSc or BScN

Tools

MS Office (Word, Excel)

Job description

This competition is open to all applicants however; internal candidates and applicants who were former employees of the University of Alberta will be given priority consideration before external candidates. Please log in to verify your internal candidate status.

This position has a term length of1 year plus 1 day.

Location - This role is in-person at North Campus Edmonton.

As an integral member of the ACURE research team, the Clinical Research Coordinator works in a dynamic, collaborative, quality-focused environment. Research staff interacts with technical, medical and management staff at the Kipnes Urology Centre, in addition to partnering hospitals and clinical trial regulatory bodies. The role of the CRC/CRN provides an interesting and challenging opportunity to collaborate with Investigators and the health care team to assume responsibility for the overall patient enrollment and coordination of clinical studies or the ACURE research projects including translationalbiomedical engineering studies.

Responsibilities

Administrative Roles 50%:

• Plans and coordinates the initiation of research study protocols.
• Participates in protocol management, reviews and adheres to multiple research protocols.
• Reconciles research accounts, assists with accounts and prepares invoices for payment.
• Assembles study-specific source documents and prepares study binders to ensure regulatory documentation is maintained to meet the study requirements.
• Contributes to the development and maintenance of protocols, ethics applications, manuals, guidelines, SOPs, intake surveys, QoL questionnaires, and other study-associated documents.
• Provides ongoing written and oral reporting with the University Health Ethics Research Office (ARISE), Northern Alberta Clinical Trials and Research Centre (NACTRC), Human Research Ethics Board of Alberta (HREBA), investigators and industry sponsors.
• Works with investigators to notify departments of the study termination/compliance and ensures appropriate retention of study files/materials.
• Conducts daily aspects of trials according to defined study protocols.
• Monitors the progress of research activities, develops and maintains records of research activities, and prepares periodic and ad-hoc reports, as needed.
• Develops and implements quality control processes throughout the study.
• Establishes, executes, reviews and evaluates laboratory policies and procedures for operating functions, including manuals and SOPs, as well as manages all laboratory department’s activities.
• Provides access to laboratory personnel for consultation and determines operational troubles in timely manner.
• Monitors, orders and receives all study, lab and drug supplies, performs drug accountability and monitors expiry dates for all supplies.
• Performs quality assurance of medical lab equipment; orders, maintains and calibrates yearly.
• Maintains and updates WHMIS documentation and all other laboratory records, reports and files.
• Organizes the research lab to accommodate ongoing requirements and changing goals of the research department.
• Other miscellaneous tasks, such as supporting other programs, as assigned.

Patient Facing Activities 50%:

• Provides instruction/teaching to study participants regarding participation, protocol requirements, follow-up schedule, and the use of data collection tools.
• Conducts patient recruitment, follow-up, data collection, case report form (CRF) completion, study monitoring, data query resolution, promotes patient’s adherence to the study and monitors patient safety in relation to the study protocols. Performs venipuncture to obtain blood samples, instructs patients to obtain urine or semen samples, requests, processes, stores tissue samples according to protocols and SOPs, and transfers samples to long-term storage facilities in a regular manner.
• Transfer samples to long-term storage facilities according to established SOPs.
• Instructs/collects/handles/transports urine, stone, implanted devices (catheters, stents etc.) from patients.

Qualifications

• BSc. or BScN. A combination of education and experience will be considered.
• Recognized certification in clinical research (ACRP or SOCRA) obtained or in progress is an asset.
• Previous clinical research experience
• Training in ICH/GCP guidelines and GCP Certificate an asset.
• Certification in Phlebotomy mandatory.
• NACTRC research course an asset.
• Proficiency with MS Office Software - Word and Excel required.
• Knowledge of IATA shipping regulations and basic laboratory procedures an asset.

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.
The Faculty of Medicine & Dentistry is one of the world’s top academic health science centres. With 21 departments, multiple research institutes and centres, and a focus on excellence in education, research, and clinical care, the faculty trains outstanding medical and dental professionals and drives global health innovation in collaboration with partners across sectors.