Clinical Research Lead

BioTalent Canada; Kingston; On-site; CAD 80,000 - 110,000; Full time

Job summary

BioTalent Canada is seeking a Clinical Research Lead to oversee clinical trials and support Principal Investigators. This role requires a Bachelor’s degree in a health-related field, 5+ years of experience in clinical trial coordination, and skills in managing research activities. The successful candidate will ensure compliance with regulations while managing research assistants and contributing to a culture of improvement in research functions.

Benefits

Healthcare of Ontario Pension Plan (HOOPP)

Employee & Family Assistance Program

Education, mentorship, and bursary opportunities

State of the Art Building with on-site parking

Qualifications

• 5+ years of experience coordinating clinical trials in hospital settings.
• Experience submitting applications to Health Canada and with DSMB.
• Certification in clinical trial coordination or project management is a plus.

Responsibilities

• Manage and oversee clinical trials from design to execution.
• Coordinate patient recruitment and screening processes.
• Ensure compliance with Health Canada guidelines and ethical practices.

Skills

Research Methodology

Data Analysis

Project Management

Supervisory Skills

Education

Bachelor’s degree in a health-related field

Master’s degree preferred

Tools

REDCap

SPSS

Excel

Job description

As a member of the Providence Care Research Department, the Clinical Research Lead (CRL) will provide on-site clinical trial support for Principal Investigators (PIs) conducting research in Providence Care. The CRL will be responsible for supporting researchers through each phase of research trials, from designing, developing and monitoring protocols to coordinating studies post-activation. Under the direction of the Director, Research & Innovation, the CRL will manage and supervise a variety of research activities from start to finish. Additionally, the CRL will manage Research Assistants, supporting their recruitment, onboarding, workload and performance assessments

Education and Experience:

• Bachelor’s degree in a health-related field, Master’s preferred
• Minimum of five (5) years of experience coordinating clinical trials (experience working in research projects and/or Health Canada regulated clinical trials in a hospital setting in aging, mental health or rehabilitation preferred)
• Experience submitting clinical trial applications to Health Canada
• Experience with monitoring clinical trials
• Experience with the Data Safety Monitoring Board (DSMB)
• Course on Research Ethics (CORE) certification on research
• Experience using the Tools for Research at Queen’s (TRAQ) system, research financial management and understanding of Health Sciences Research Ethics Board (HSREB) is an asset
• Certification in clinical trial coordination (e.g. Society of Clinical Research Associates (SOCRA); project management certification) would be an asset
• Previous experience as a study co-ordinator is an asset
• Consideration may be given to an equivalent combination of education and experience
• Advanced computer proficiency, with knowledge of computer software applications for data analysis, reporting and presentations (e.g., Research Electronic Data Capture (REDCap), SPSS, Access, Excel, Word & PowerPoint)
• Demonstrated knowledge of research methodology and tools, and research ethics
• Demonstrated familiarization with study protocols in clinical trials, and their implementation and reporting requirements

Position Responsibilities

Research Administration

• Launches and provides administrative guidance and oversight to clinical trials and other research projects and studies, including coordinating day-to-day study activities
• Provides general consultation to PIs regarding study design and feasibility
• Develops project/study protocols and other materials (e.g. questionnaires, data forms, etc.) and ensures study manual(s) are kept up-to-date
• Adheres to the instructional guidelines from PIs on the completion of consent forms, questionnaires and process to acquire data
• Oversees the management of patients within studies, including screening/recruiting participants, coordinating patient schedules and activities as per protocol
• Maintains strict participant and data confidentiality
• Plans, implements, and coordinates all aspects of data collection, documentation and audits
• Ensures the accuracy, integrity, and compliance of data collected during clinical trials, monitoring and identifying gaps in documentation
• Assesses potential risks associated with study procedures, monitors adverse events, and ensures informed consent processes are followed
• Responds to research inquiries and refers concerns to the PI;
• Manages and tracks budget for study/project; assists with financial operations (e.g., submits expense claims; reimburses participants, purchases supplies; processing invoices; monitoring accounts and budgets)
• Establishes administrative-level contacts and maintains on-going relationships with relevant institutions/ hospitals, universities and funding agencies
• Ensures compliance of study activities with Health Canada guidelines for clinical trials and according to Good Clinical Practice (GCP) and International Council for Harmonization (ICH) guidelines and ethical research practices
• Provides oversight for compliance and data monitoring and connecting with the Data Safety Monitoring Board (DSMB)
• Provides support, advice and leads submission process of a Clinical Trial Application (CTA) for investigator-initiated Health Canada regulated clinical trials
• Conducts and leads regular meetings with Principal Investigator(s) and research study team to communicate up-to-date information on the progress of the study/ project
• Attends regular lead/research personnel meetings and contribute to a culture of a balanced lifestyle, well-being, cooperation, and respect
• Supports Providence researchers with grant application preparation and submission (e.g., drafts budgets and application content, obtains institutional approvals, acquires signatures, uploads documents online, prepares common CVs)
• Collects and maintains regulatory files for specific studies such as Standard Operating Procedures and archives study materials, as applicable
• Collaborates in publication authorship, literature reviews, submitting grant applications, REB submissions, manuscripts, seminar presentations, and reports
• Assists in the preparation, submission, and tracking of research proposals for approval of the Research Ethics Board.
• Analyzes experimental data and present information in an appropriate form (e.g., word processing; spreadsheet manipulation; preparation of graphs, tables, and figures), where applicable
• Assists in preparing annual summary of research accomplishments
• Assists with the preparation of abstracts, oral and written reports, oral presentations, manuscripts, reports findings to clinical teams and managers, and publications based on research findings
• Maintains communication among research team members through regular e-mail contact, meetings, newsletters, and other means
• Supports the Director by developing and implementing strategic initiatives to enhance research functions
• Supports the Director in the development and implementation of new policies and practices
• Manages the day to day operations of the biohazard level two (2) wet labs in Providence Care Hospital, including the monitoring and proactive ordering of supplies and equipment as required
• Acts as Safety Officer for wet labs and delivers training to new users and ensures compliance to the standard operating procedures
• Manages access, scheduling and use of the wet lab
• Manages the Biohazard certification from Queen’s University and those authorized to use this facility
• Advises the Director on strategies to maintain and/or acquire new equipment for the lab
• Completes and updates mandatory research courses such as Health Canada Division 5, Good Clinical Practice (GCP), and Tri Council Policy Statement (TCPS 2), and clinical research coordination
• Provides project specific training/mentoring to new team members and students
• Trains incoming study personnel specific to clinical trials in Providence Care
• Provides direction, leadership and supervision to Research Assistants on all assigned projects
• Monitors team workload and adjusts work assignments as warranted to support the timely delivery of research team goals;
• Facilitates the recruitment of new team members, working with support from Human Resources and the Director, Research & Innovation to coordinate recruitment, interviewing, hiring and orientation, as needed
• Supervises the performance of direct reports, providing ongoing coaching, mentoring and counseling

Why Work at Providence Care Hospital:

• Specialized sub-acute Care in rehabilitation, mental health services, complex medical management and palliative care
• A hospital striving for excellence in care, education and research
• Committed to people centred approach to care delivery
• Competitive salaries with excellent full-time benefits
• Healthcare of Ontario Pension Plan (HOOPP)
• State of the Art Building with on-site parking
• On-site café and cafeteria with a variety of food options
• Corporate and unit/service specific orientation for new hires
• Focus on Healthy Workplace & Culture of Quality
• Employee & Family Assistance Program
• Education, mentorship and bursary opportunities
• Fully affiliated with Queen’s University and St. Lawrence College and other academic institutions
• Located on the shores of Lake Ontario surrounded by park land and walking trails