Senior Research Coordinator
Apply NowCompany: Hamilton Health Sciences
Location: Hamilton, ON L8H 7T6
Description:
Unit Summary
The Interventional Cardiology Research Group is a collaboration of investigators, research nurses, study coordinators and research assistants in support of ongoing research and education. Interventional Cardiology Research group involved in ACs and device trials.
Position Summary
The Senior Research Coordinator's purpose is to lead a team in the local or central coordination of one or more multicenter research studies. The Senior Research Coordinator is accountable to the Principal Investigator (PI) and reports to the PI and research manager. He or she is responsible for the management of staff assigned to the study, as well as the primary point of contact for internal departments (e.g. stats, finance, ICT , pharmacy, Core lab, CRLB, diagnostic imaging, patient care areas, etc. ) and external stakeholders (e.g. sponsor, CRO, vendors, grant/funding agency).
Senior Research Coordinator is responsible for all aspects of research projects highlighted below.
Local Coordination:
Work with director in selecting, planning, implementing and tracking research project
Recruit, train, and manage/supervise the local research team including research assistants, coordinators, students, and nurses.
Account management. Developing and negotiating study budgets based on trial resource requirements, managing and ensuring studies are completed within budget
Manage all aspects of the study related to patient management and study implementation, provide training to health professionals and act as a liaison between the investigator/research staff and hospital department
Patient recruitment and Follow-up. Responsible for patient screening, randomization, study drug/device allocation and accountability, patient follow-up, REB submissions, adverse event reporting, as well as accurate case report form completion on all patients.
Liaise with sponsor, arrange monitoring visits and monitor local study conduct
Audit preparation
Travel as required for investigator meetings and conference
Carry a pager for after hours and weekend call
Central Coordination:
Review and provide input into research study protocols
Ensure relevant clinical and research methodology is applied throughout the conduct of the research study.
Request and evaluate various external vendors and facilitate contracts and budget negotiations with chosen vendors
Liaise and coordinate with internal departments to ensure requirements and timelines are achieved as required
Support the PI in the identification, development and organization of required study committees (e.g. Steering, Event Adjudication, DSMB).
Design study management plans as required for the conduct of the research study (e.g., data management plan, monitoring plan, adjudication plan, investigational product (IP) management plan, safety management plan, etc.)
Monitor study management plans throughout project and revise as necessary
Recruit, hire and train required staff members to implement the research study
Develop and design materials to assist in conduct of study, including informed consent form templates, recruitment materials, manual of operations, training material, etc.
Train investigator site study personnel on research project
Support sponsor and/or study sites in the initial submission and ongoing compliance to regulatory authorities, as required.
Assist investigators and local sites with initial, annual and final ethics committee submissions
Coordinate regular meetings with internal and external stakeholder
Develop and conduct training for investigator site and other local study staff
Forecast recruitment, country/site activation, quantity of IP required to be packaged and shipped to country depots and sites, and required timing
Organize, facilitate, complete and/or assist in the conduct of internal and external audits and inspections (e.g., IP vendors, investigator sites, national leader offices etc.)
Control for risk identification, risk mitigation and issue resolution for the research study
Develop targets and timelines for deliverables, anticipates potential delays and proactively develop strategies to achieve a positive outcome
Create reports to review and monitor key quality indicators, such as recruitment, drug adherence and safety
Monitor and ensure ongoing study compliance with the protocol, standard operating procedures and applicable regulation
Serve as an escalation point for project issue
Engage in quality assurance activities to ensure project deliverables are met according to both HHSC-Research SOPs and project requirement
Participation on internal working groups and policy and standard operating procedure development and review
Present at external and/or internal meeting
Create presentation/slide content and meeting material development
Prepare and present reports, abstracts, posters and academic manuscript
Develop tables and charts for manuscripts and/or presentation
Organize and facilitate data transfers with external stakeholders (both incoming and outgoing)
Coordinate the design, development and implementation of study database, and other required study systems as required. (i.e. Randomization, drug management, websites)
Manage and coordinate the collection, entry, verification, analysis and reporting of research study data and quality indicators
Design of the study database, case report forms and required edit checks, in accordance with protocol and study requirement
Organize and monitor of regular data collection activities, including quality control reports, data entry and data review/validation using pre-existing or newly created report
Ongoing management of data collection and validation systems, processes and associated documentation
Identify staffing requirements/work
Lead in recruitment process and recommend final candidate
Provide leadership, coaching, training and mentorship to study team members, including the development of bi-annual performance review
Distribute and prioritize task assignments on a regular basis (daily/weekly)
Manage the performance and workload for study team member
Conduct and complete biannual performance reviews for direct report
Identify knowledge gaps for study team members and create development plan
Negotiate and resolve conflicts among study team member
Development of research study budgets, in collaboration with Finance, PI and PM.
Negotiate budgets with vendors, sites, national leaders, in collaboration with Finance, PI and PM
Ongoing review and approve study-related invoices, patient fee runs and other study related payments and expense
Confirm ongoing adherence to study budget
Contribute to writing and assembly of grant applications to external funding agencie
Schedule Work Hours
Full-time hours (37.5 hours/week).
Qualifications
Minimum 5 years previous experience in multi-centre research studie
Experience with the management of large clinical research datasets
Excellent communication, problem solving skills and ability to work flexible hour
Working knowledge of project management processe
Working knowledge of ICH-GCP Guidelines and international research requirement
Broad knowledge of research methodology, clinical trials and drug development processe
Supervisory experience
Preferred: Working knowledge of HHSC systems, processes, organizational structure and SOPs.
Guidelines
Hamilton Health Sciences fosters a culture of patient and staff safety, whereby all employees are guided by our Mission, Vision, Values, and Values Based Code of Conduct. Hamilton Health Sciences is a teaching hospital and all staff and physicians are expected to support students and other learners.
To be considered for this opportunity applicants must apply during the posting period. All internal and external applicants may ONLY apply via the Careers website.
Hamilton Health Sciences is an equal opportunity employer and we will accommodate any needs under the Canadian Charter of Rights and Freedom, Accessibility for Ontarians with Disabilities Act and the Ontario Human Rights Code. Hiring processes will be modified to remove barriers to accommodate those with disabilities, if requested. Should any applicant require accommodation through the application processes, please contact HR Operations at 905-521-2100, Ext. 46947 for assistance. If the applicant requires a specific accommodation because of a disability during an interview, the applicant will need to advise the hiring manager when scheduling the interview and the appropriate accommodations can be made.
This competition is open to all qualified applicants, however, qualified internal applicants will be considered first. Past performance will be considered as part of the selection process. If you are a previous employee of Hamilton Health Sciences, please note: the circumstances around an employee's exit will be considered prior to an offer of employment. Proficiency in both Official Languages, French and English, is considered an asset.
If this position is temporary, selection for this position will be as per the outlined Collective Agreements:
Article 30 (k), CUPE Collective Agreement
Article 10.7 (d), ONA Collective Agreement
Article 13.01 (b) (ii), OPSEU 273 Collective Agreement
Article 14.04, OPSEU 209 Collective Agreement
Article 2.07 and Article 13, PIPSC RT Collective Agreement
The Interventional Cardiology Research Group is a collaboration of investigators, research nurses, study coordinators and research assistants in support of ongoing research and education. Interventional Cardiology Research group involved in ACs and device trials.
Position Summary
The Senior Research Coordinator's purpose is to lead a team in the local or central coordination of one or more multicenter research studies. The Senior Research Coordinator is accountable to the Principal Investigator (PI) and reports to the PI and research manager. He or she is responsible for the management of staff assigned to the study, as well as the primary point of contact for internal departments (e.g. stats, finance, ICT , pharmacy, Core lab, CRLB, diagnostic imaging, patient care areas, etc. ) and external stakeholders (e.g. sponsor, CRO, vendors, grant/funding agency).
Senior Research Coordinator is responsible for all aspects of research projects highlighted below.
Local Coordination:
Work with director in selecting, planning, implementing and tracking research project
Recruit, train, and manage/supervise the local research team including research assistants, coordinators, students, and nurses.
Account management. Developing and negotiating study budgets based on trial resource requirements, managing and ensuring studies are completed within budget
Manage all aspects of the study related to patient management and study implementation, provide training to health professionals and act as a liaison between the investigator/research staff and hospital department
Patient recruitment and Follow-up. Responsible for patient screening, randomization, study drug/device allocation and accountability, patient follow-up, REB submissions, adverse event reporting, as well as accurate case report form completion on all patients.
Liaise with sponsor, arrange monitoring visits and monitor local study conduct
Audit preparation
Travel as required for investigator meetings and conference
Carry a pager for after hours and weekend call
Central Coordination:
Review and provide input into research study protocols
Ensure relevant clinical and research methodology is applied throughout the conduct of the research study.
Request and evaluate various external vendors and facilitate contracts and budget negotiations with chosen vendors
Liaise and coordinate with internal departments to ensure requirements and timelines are achieved as required
Support the PI in the identification, development and organization of required study committees (e.g. Steering, Event Adjudication, DSMB).
Design study management plans as required for the conduct of the research study (e.g., data management plan, monitoring plan, adjudication plan, investigational product (IP) management plan, safety management plan, etc.)
Monitor study management plans throughout project and revise as necessary
Recruit, hire and train required staff members to implement the research study
Develop and design materials to assist in conduct of study, including informed consent form templates, recruitment materials, manual of operations, training material, etc.
Train investigator site study personnel on research project
Support sponsor and/or study sites in the initial submission and ongoing compliance to regulatory authorities, as required.
Assist investigators and local sites with initial, annual and final ethics committee submissions
Coordinate regular meetings with internal and external stakeholder
Develop and conduct training for investigator site and other local study staff
Forecast recruitment, country/site activation, quantity of IP required to be packaged and shipped to country depots and sites, and required timing
Organize, facilitate, complete and/or assist in the conduct of internal and external audits and inspections (e.g., IP vendors, investigator sites, national leader offices etc.)
Control for risk identification, risk mitigation and issue resolution for the research study
Develop targets and timelines for deliverables, anticipates potential delays and proactively develop strategies to achieve a positive outcome
Create reports to review and monitor key quality indicators, such as recruitment, drug adherence and safety
Monitor and ensure ongoing study compliance with the protocol, standard operating procedures and applicable regulation
Serve as an escalation point for project issue
Engage in quality assurance activities to ensure project deliverables are met according to both HHSC-Research SOPs and project requirement
Participation on internal working groups and policy and standard operating procedure development and review
Present at external and/or internal meeting
Create presentation/slide content and meeting material development
Prepare and present reports, abstracts, posters and academic manuscript
Develop tables and charts for manuscripts and/or presentation
Organize and facilitate data transfers with external stakeholders (both incoming and outgoing)
Coordinate the design, development and implementation of study database, and other required study systems as required. (i.e. Randomization, drug management, websites)
Manage and coordinate the collection, entry, verification, analysis and reporting of research study data and quality indicators
Design of the study database, case report forms and required edit checks, in accordance with protocol and study requirement
Organize and monitor of regular data collection activities, including quality control reports, data entry and data review/validation using pre-existing or newly created report
Ongoing management of data collection and validation systems, processes and associated documentation
Identify staffing requirements/work
Lead in recruitment process and recommend final candidate
Provide leadership, coaching, training and mentorship to study team members, including the development of bi-annual performance review
Distribute and prioritize task assignments on a regular basis (daily/weekly)
Manage the performance and workload for study team member
Conduct and complete biannual performance reviews for direct report
Identify knowledge gaps for study team members and create development plan
Negotiate and resolve conflicts among study team member
Development of research study budgets, in collaboration with Finance, PI and PM.
Negotiate budgets with vendors, sites, national leaders, in collaboration with Finance, PI and PM
Ongoing review and approve study-related invoices, patient fee runs and other study related payments and expense
Confirm ongoing adherence to study budget
Contribute to writing and assembly of grant applications to external funding agencie
Schedule Work Hours
Full-time hours (37.5 hours/week).
Qualifications
Minimum 5 years previous experience in multi-centre research studie
Experience with the management of large clinical research datasets
Excellent communication, problem solving skills and ability to work flexible hour
Working knowledge of project management processe
Working knowledge of ICH-GCP Guidelines and international research requirement
Broad knowledge of research methodology, clinical trials and drug development processe
Supervisory experience
Preferred: Working knowledge of HHSC systems, processes, organizational structure and SOPs.
Guidelines
Hamilton Health Sciences fosters a culture of patient and staff safety, whereby all employees are guided by our Mission, Vision, Values, and Values Based Code of Conduct. Hamilton Health Sciences is a teaching hospital and all staff and physicians are expected to support students and other learners.
To be considered for this opportunity applicants must apply during the posting period. All internal and external applicants may ONLY apply via the Careers website.
Hamilton Health Sciences is an equal opportunity employer and we will accommodate any needs under the Canadian Charter of Rights and Freedom, Accessibility for Ontarians with Disabilities Act and the Ontario Human Rights Code. Hiring processes will be modified to remove barriers to accommodate those with disabilities, if requested. Should any applicant require accommodation through the application processes, please contact HR Operations at 905-521-2100, Ext. 46947 for assistance. If the applicant requires a specific accommodation because of a disability during an interview, the applicant will need to advise the hiring manager when scheduling the interview and the appropriate accommodations can be made.
This competition is open to all qualified applicants, however, qualified internal applicants will be considered first. Past performance will be considered as part of the selection process. If you are a previous employee of Hamilton Health Sciences, please note: the circumstances around an employee's exit will be considered prior to an offer of employment. Proficiency in both Official Languages, French and English, is considered an asset.
If this position is temporary, selection for this position will be as per the outlined Collective Agreements:
Article 30 (k), CUPE Collective Agreement
Article 10.7 (d), ONA Collective Agreement
Article 13.01 (b) (ii), OPSEU 273 Collective Agreement
Article 14.04, OPSEU 209 Collective Agreement
Article 2.07 and Article 13, PIPSC RT Collective Agreement