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SUMMARY OF THE ROLE RESPONSIBILITIES:
In accordance with the established vision and values of the organization, the Regional Manager, Clinical Research is a specialized research professional that works under the oversight of the Principal Investigator (PI) within individual studies and reports to the Regional Director, Research Evaluation and Analytics. The Regional Manager, Clinical Research performs multiple functions in a complex and dynamic work environment including acting as the primary administrative point of contact for internal research staff and the operational liaison for other research organizations, funding agencies and regulating bodies.
The Regional Manager, Clinical Research has a key role in developing the plan for new clinical trials in terms of determining budget and operational planning (e.g., liaison with Northern Health (NH) clinical department staff, space requirements, and physicians). As Northern Health is a small organization with a small number of clinical trials underway, the Manager also performs many of the functions that a clinical research coordinator would typically be responsible for: supports, facilitates, and organizes daily clinical trial and study participant activities and plays a critical role in study conduct. The Manager screens, enrolls, and follows study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the Manager is responsible for participant safety, data integrity and reporting, and regulatory compliance for research studies; this includes ensuring that data is submitted on a timely basis; source documentation is accurate and complete; and all ethical and regulatory requirements are met. Data management responsibilities include: the collection, analysis, confidentiality, and quality assurance review of study participant clinical and research data. By performing these duties, the Manager works with the PI and study team/vendors to ensure the successful conduct of regulatory-compliant and ethically sound studies.
FUNCTIONAL REPORTING RELATIONSHIPS:
The Regional Manager, Clinical Research reports to the Director, Research Evaluation and Analytics. This position will work closely with a broad spectrum of clinicians involved in clinical research (physicians, nurses, laboratory technologists, and pharmacists), the Director of Tertiary Services, and research stakeholders at UNBC and other academic and health research institutions.
KEY AREAS OF RESPONSIBILITY:
– Oversees the daily activities of departmental research staff with respect to performance, efficiency and compliance to contractual requirements, study protocols, applicable regulations and research ethics requirements in the conduct of clinical research.
– Assists in the development of Standard Operating Procedures (SOPs) for key clinical research activities to ensure regulatory compliance and standardized, efficient business processes. Implements corrective actions in response to protocol, regulatory or SOP deviations and preventative actions in cases where the potential for non-compliance is identified.
– Mentorship to clinical research staff and participates in the development of educational symposia, workshops and training tools.
– Supports new Principal Investigators and co-investigators develop clinical research skills and expertise, make possible an increase in the number of Principal Investigators across therapeutic areas at NH and maintains strong and positive relationships with NH’s Investigator community.
– Engages study Sponsors in problem-solving discussions where operational problems potentially impacting resources or compliance arise with protocols, instructions, data collection tools or other technologies arise.
– Conducts study-related activities in accordance with the study protocol and Sponsor’s instructions, institutional policy and standard operating procedures, Good Clinical Practice (GCP standards), ethical requirements, and applicable national and international regulations.
KEY AREAS OF RESPONSIBILITY CONTINUED:
– Oversees clinical trial protocol, contract, and budget development and review process.
– Develops and implements the clinical trial recruitment and retention plan for each study.
– Recruits and enrolls participants into the clinical trials in accordance with protocol inclusion/exclusion criteria. Conducts the informed consent process.
– Implements the research protocol and all required procedures within the scope of qualifications and under the delegation of the PI. Diligently consults with Research Nurses on data, protocol, or patient assessment issues.
– Ensures that the rights, safety, and welfare of all participants are respected and protected as per applicable ethical requirements, GCP and regulations.
– Either oversees or participates directly in timely (real time) study data collection, query resolution, analysis, and quality assurance throughout the trial. Ensures that essential documents are archived following study completion.
– Performs data management activities on both paper-based and electronic data capture (EDC) studies, in accordance with Good Documentation Practices (attributable, legible, contemporaneous, original, and accurate – ALCOA), Good Clinical Practice (GCP standards, NH research policies and procedures, and applicable research and privacy legislation).
– Participates in internal and external audit procedures.
– Either oversees or participates directly in regulatory and research ethics document preparation, submission, update, and management.
– Ensures ongoing and precisely documented communication with Sponsors, Monitors, and regulatory bodies, as required, for a broad range of study activities including, but not limited to, safety reporting.
– Maintains investigational drug/device accountability records and ensures the investigational products are stored and accessed in accordance with Sponsor instruction.
– Performs other related duties as assigned.
QUALIFICATIONS AND COMPETENCIES
Education and Experience:
– Bachelor’s degree (minimum) in a health or health-research related field and 7 (seven) to 10 (ten) years experience in clinical research, including managerial responsibilities and leading change initiatives in a research-focused organization.
– Certification through the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) as a Certified Clinical Research Coordinator (CCRC), a Certified Clinical Research Associate (CCRA), or a Certified Clinical Research Professional (CCRP) is strongly preferred. Certification is required within two years of hire date.
– Completion of Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans and GCP requirements for protection of the rights of study participants training.
– Or an equivalent combination of education, training and experience.
Knowledge, Skills and Abilities:
– In-depth knowledge of Health Canada Food and Drug Act, Division 5, Part C; International Committee on Harmonization Part E6 – Good Clinical Practices; and US Food and Drug Act regulations 21 CFR and 45 CFR part 46 pertaining to clinical trials.
– Functional understanding of the Freedom of Information and Privacy Act (FIPPA), in particular section 35.
– Excellent interpersonal skills, advanced written and verbal communication, pro-active problem-solving abilities, and a well-demonstrated ability to work with others as part of an interdisciplinary team.
– Exceptional attention to detail and an advanced ability to organize information and multi-task/ prioritize in a busy environment.
– Ability to manage multiple concurrent projects, assess priorities and utilize resources effectively.
– Strong, supportive and enabling managerial and leadership skill.
– Highly proficient with databases, MS Office (particularly Word, Excel, and PowerPoint), email, and the internet.
– Experience with Remote Data Capture (RDC) and Electronic Data Capture (EDC) systems.
– Physical ability to perform the duties of the position.