- Coordinates, monitors and supervises all study activities to ensure proper execution of assigned clinical research trials and to ensure that study protocols, SOPs, ICH-GCPs and regulatory requirements are met.
- Acts as a Leader by advising CRCs, Study Preparation Associates, Clinical Research Technicians, and Safety Staff on proper trial execution based on protocol, SOP, and regulatory requirements.
- Conducts CRC and RA training.
- Meets and addresses issues with study monitors, sponsors and regulatory agencies as appropriate
- Respond to queries by internal departments on trial conduct
- Participates in review and development of study protocols, SOPs, and internal procedures
- Analyzes and develops action plans to address QC/QA findings, including development of CAPA reports
- Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements
- Performs CRC, RA and/or Study Preparation Associate duties if required
- Maintains adequate, accurate, complete and legible records
- Detailed review of study participant and study documentation, CRFs and source documents
- Conducts Protocol training for clinical research staff and Investigators.
- Works with QC and QA during audits and audit follow-ups
- Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
- Performs other tasks as assigned and as training and experience allow
- Serve as primary contact for multiple studies/sites
- Prepare for and conduct study monitor visits and audits
- Serves as a liaison to physicians, investigators, patients and other staff members regarding the research process and individual protocols
- Submit and Review Institutional Review Board documents
- Strategizes and helps troubleshoot to correct problems
- Escalates issues as needed to supervisor
- 3-5 years work experience as a Clinical Research Coordinator
- Certification as a Clinical Research Professional (SOCRA, ACRP, etc.)
- Current GCP and familiarity with Health Canada, FDA, ICH GCP regulations
- Current GCP, Health Canada Part C Division 5, IATA certifications
- Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience.
- Ability to work in a fast paced environment with a high degree of organization.
- Experience with Microsoft Office (Word, Excel, Power point, etc.)
- Phlebotomy certification
- Excellent organization and attention to detail
- Quick and eager learner
- Ability to work independently
- Strong critical thinking
- Excellent oral and written communication
- 3-5 years of experience in related field
- Working knowledge of research methodology/medical terminology
- Meticulous work ethic and attention to detail, with excellent time-management and organizational skills.
- Ability to manage competing demands of short and long-term projects led by numerous individuals, directing multiple varied assignments, independently coordinating and prioritizing relevant projects, tasks and responsibilities.
- Highly motivated and adaptable with an ability to take initiative and work well independently and as part of a multidisciplinary team.
- Ability to produce high quality work while meeting deadlines in accordance to CTU standards.
- Ability to maintain confidentiality.
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Senior Research Coordinator - Toronto, Canada - Baycrest
Description
The Rotman Research Institute at Baycrest has an opportunity for
SENIOR RESEARCH COORDINATOR
Position Type: Temporary Full-Time (1 Year)
Shift Type: Day
Bi-Weekly Hours: 70 Hours
Hours of Work: 7 hrs/shift
Posting Number: 7352
Union: Non-Union
Date Posted: January 10, 2024Internal Closing Date: March 31, 2024
Job Summary:
The Anne and Allan Bank Centre for Clinical Research Trials in the Rotman Research Institute of the Academy for Research and Education at Baycrest Centre for Geriatric Care is seeking a Senior Research Coordinator. The Centre for Clinical Research Trials is a multidisciplinary specialist unit, which has been set up to design, conduct, analyse and publish clinical trials and other studies. The Rotman Research Institute (RRI) is a premier interdisciplinary, international centre for the study of human brain function. Our core research themes are: Cognitive Neuroscience, Aging and Brain Health, Alzheimer's and Related Diseases, Computational Modeling and Neuroinformatics. Our research focuses on cognitive brain functions (including memory, executive function, attention, perception, and language), both in normal aging and in the presence of diseases and conditions that affect the brain, such as Alzheimer's disease and other dementias, stroke, and traumatic brain injury. The Rotman Research Institute supports behavioral, neuropsychological, neuroimaging, and neurocomputational studies with state-of-the-art facilities, including eye-tracking, electroencephalography, and magnetoencephalography laboratories and a research-dedicated Siemens 3 Tesla MRI in-house at Baycrest.
Responsibilities include but are not limited to:
Qualifications include but are not limited to:
Required Skills:
JOIN OUR TEAM: Please submit your application online by clicking the Apply button below. Applications will include a recent CV, a brief letter of interest, and names and contact information of 3 potential references. Although the closing date for applications is March 31, 2024, we encourage individuals to submit their applications as early as possible.
The Rotman Research Institute is committed to fostering a climate of equity, diversity, inclusion, and accessibility. This commitment is central to, and mutually supportive of, our research excellence mandate. We welcome and respect the diversity of all members of our community, and we support an inclusive culture for our clients, families, research scientists, staff, and participants, trainees, volunteers, trustees, and partners. We welcome applications from Black individuals and other racialized persons, Indigenous Peoples, women, persons with disabilities, LGBTQ2SA+ persons, and others who may contribute to the further diversification of ideas within our community. We are committed to fair assessment of a candidate's abilities, and consideration for diversity of thought, method, and experience, including non- traditional career paths. Accommodation will be provided in all parts of the hiring process where needed.
Please note that Baycrest has implemented mandatory vaccination for all employees. It is a condition of employment that new employees provide proof that they are fully vaccinated against COVID-19 prior to the start date of employment. This means that all new employees must have received all required doses of a COVID-19 vaccine approved by Health Canada at least 14 days prior to their start date. In addition, it is a condition of employment that all new hires obtain and submit proof of all booster vaccines as approved and recommended by Health Canada.
Applicants who have appropriate written proof of a medical reason, or a reason pursuant to the Ontario Human Rights Code, for not being fully vaccinated against COVID-19 may provide such documentation to the Human Resources department. Such situations will be considered on a case-by-case basis.
Remarkable people of Baycrest Health Sciences
are changing the future of brain health and aging.
Thank you for your interest in joining Baycrest. Only those selected for an interview will be contacted.
Baycrest is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act ('AODA'). If you require accommodation for disability during any stage of the recruitment process, please notify Human Resources at or , ext. 2961.
All successful candidates will be required to complete a police reference check/vulnerable sector screen and submit proof of two doses of vaccination against COVID-19, unless exempt. Such exemptions will be considered on a case-by-case basis.
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Required Skills
Required Experience