Clinical Research

Clinical Research Coordinator - NR 4

Purpose:

Primary responsibility for the execution of the basic scientific tasks of the research project(s) and contributing to the ongoing management, progress evaluation, and information dissemination relating to the project(s).

Typical tasks and duties:

Subject recruitment and enrolment

  • Identifies and recruits subjects for research studies, including people from high risk populations and working with professional health care and service providers and caregivers to identify and recruit subjects.
  • Enrols subjects into the research project including screening, informed consent processes, and communication of safety and compliance issues.

Data collection and management

  • Assists with writing and implementing study protocols.
  • Follows established policies, procedures, and objectives, continuous quality improvement objectives, and safety, environmental, and/or ethical standards.
  • Performs and interprets literature and database searches in research and other databases (for example, PubMed, CINAHL, etc.).
  • Carries out routine tests, experiments, and procedures which may include nursing functions such as collecting blood samples, administering study medication, physiological measurements and testing etc.
  • Conducts interviews (face-to-face and telephone) and focus groups or other forms of data collection (eg. questionnaire administration, gathering policy documents).
  • Assists in the setup, operation, and maintenance of research equipment/instruments.
  • Prepares, organizes and leads focus group sessions with study subjects, partner communities, etc.
  • Assists with the logistics of focus group sessions – material for participants packages, meeting arrangements, note taking and taping of sessions.
  • Collects and manages data, including collection and compilation of source documents, using and developing case report form and data collection forms, filing and archiving and ensuring availability and integrity of source documents, managing monitoring visits.
  • Assists with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
  • Prepares tables, graphs, fact sheets, and written reports summarizing research results.

Data analysis and interpretation

  • Collects, codes and transcribes data.
  • Analyzes and interprets data using statistical analysis programs and qualitative data analysis software (such as NVivo).
  • Reviews data and analytical results and provides recommendations to principle investigators.

Conduct of research project

  • Participates in developing and evaluating strategies to meet the project goals and objectives.
  • May lead, train, or supervise student employees and/or other research support personnel.
  • Prepares and/or assists with the preparation, writing, translation (English and French), of key documents including ethics applications, project reports, manuscripts for publication, abstracts, scientific posters and presentations.

Assists with any other duties required by the research project or management of the research lab.

Knowledge, skills, education and experience:

  • Undergraduate degree in health sciences, biomedical or a related discipline; graduate degree is an asset.
  • Professional designation appropriate to the field (e.g. RN, Registered Dietitian, etc.) is an asset .
  • One to two (1 – 2) years experience in research positions.
  • Familiarity with quantitative research methods, statistics and their applications.
  • Familiarity with qualitative research methodologies and their applications.
  • Experience with literature searches and retrievals using electronic database.
  • Intermediate computer skills and experience using MS Office (Excel, Power Point, Word, Access).
  • Ability to prioritize multiple tasks, to work under pressure, to effectively manage overlapping duties and to meet deadlines.
  • Ability to attend to detail and display resourcefulness.
  • Strong organisational, time management, coordination and facilitation skills.
  • Exceptional interpersonal and communication skills as well as the ability to work in a team environment. Advanced written and verbal skills in English or French. Bilingualism, spoken and written, is preferred.
Clinical Research Associate - NR 6

Purpose:

Primary responsibility for implementation, coordination, evaluation, communication and/or management of research studies.

Typical tasks and duties:

Project preparation

  • Conducts detailed operational preparation of research project including schedules, progress, coordination, deliverables, milestones of the project.
  • Collaborates in development of new techniques and develops research instruments.
  • Develops and assesses qualitative and quantitative research instruments (i.e. structured interviews, questionnaires, document/chart review matrix, etc.), with a strong understanding of the requirements of valid, reliable and feasible application in onsite, on‐line and field settings.
  • Refines and adapts research methodologies and research instruments as the project progresses in light of results being obtained and of effectiveness of project implementation, as directed by the Project Investigator or senior research staff.
  • Writes, edits and submits protocols and other required research documentation for research ethics and regulatory matters.

 Project implementation, management and oversight

  • Performs on‐site field research at local, regional and international levels.
  • Applies a variety of research techniques to gather information and research data in the pursuit of research objectives, by directing or carrying out such methodologies as surveys and questionnaires, participant observation, interviews (face‐to‐face, telephone and online), focus groups, literature reviews, internet‐based and library research, document analysis, case studies or other investigative techniques.
  • Ensures that the rights and well‐being of human subjects are respected and protected.
  • Participates in subject recruitment processes as needed.
  • Conducts research project activities requiring a higher level of autonomy, training or skill.
  • Contributes to production of critical reviews or editions.
  • Tracks/monitors/provides justification for all financial aspects of the project ensuring accurate and timely reporting (including, if required, travel and in kind contributions of Principal Investigator and all other partners).

Data collection and management

  • Oversees data collection, entry and record keeping.
  • Develops and maintains systems for organizing and curating all qualitative research activities and data including recording of information obtained during or created immediately post data collection.
  • Prepares, manipulates, and manages extensive databases.
  • Provides ready access to all experimental data for the faculty researcher and/or supervisor.

Data Analysis and Interpretation

  • Oversees the execution of all phases of data analysis plan(s) and contributes to components currently being developed.
  • Interprets data, information and /or experimental and analytical results to identify key issues, to understand trends, characteristics and tendencies and to generate conclusions.
  • Conducts sophisticated and/or advanced data analyses which may require specialized expertise and experience and interprets results.
  • Informs Principal Investigator of project results, analyses, and interpretation, including thoughts on their impact on the conduct of the project so that appropriate adjustments can be made as the work progresses.

Project management

  • Welcomes, trains, guides, and supervises students and research staff.
  • Develops and maintain reference libraries and other references, which may include using knowledge management software.
  • Ensures eligibility of project expenditures in accordance with funding agency requirements.
  • Develops and implements regulatory compliance processes including data security, privacy, ethics, etc.
  • Develops and implements research quality control procedures.
  • Manages research study including subject interaction, implementation of study design and controls, and on- and off-site trouble shooting.
  • Monitors the status of individual or multiple projects and ensures that interim and final deadlines are met.
  • Designs, develops and maintains existing and new database systems, including interfaces with web sites and including programming as necessary.
  • Solves maintenance problems with existing and new electronic resources, including programming as necessary.
  • Improves the operation of computing resources through continuing evaluation, development and documentation to ensure effective provision of support.

Project administration

  • Develops, documents and implements procedures to ensure accurate and timely reporting.

Writing up and submitting research results for publication or presentation

  • Contributes to the drafting and submitting of papers to peer reviewed journals/conferences/workshops and of grant proposals and applications.
  • Summarizes in written format (i.e. report suitable for submission to client and/or funding agency) information relating to project design, implementation, evolution and findings.

Organize and / or participate in information dissemination activities

  • Conducts research dissemination events including conferences, seminars and workshops.
  • Conducts and develops material for research coordination events including conferences, seminars and workshops amongst project investigators and stakeholders.
  • Attend and contribute to relevant research and research dissemination meetings.

Promote application and impact of research work and results

  • Summarizes results in written format suitable for consumption by lay audiences unfamiliar with statistical techniques and terminology.
  • Summarizes results in written format understandable by the “educated professional” (i.e. college--‐educated individual)

Assists with any other duties required by the research project or management of the research lab.

Knowledge, skills, education and experience:

  • Minimum of an undergraduate degree in a related discipline; graduate degree is preferred.
  • Two to five years’ experience in research positions or one to two years of research experience with a graduate degree in a relevant discipline.
  • Minimum of two years’ experience with qualitative research methodologies used in research projects or program.
  • Ability to work independently, adapt rapidly to change and to demonstrate flexibility and initiative.
  • Strong organizational, analytical and tech/scientific oral/writing skills.
  • Exceptional interpersonal and communication skills as well as the ability to work in a team environment.
  • Ability to coordinate workflow.
  • Sound judgement in applying scientific principles & predicting/preventing problems.
  • Ability to adapt protocols as needed (within guidelines).
  • Strong computer skills and experience using qualitative and quantitative analysis software and with MS Office (Excel, Power Point, Word, Access).
  • Advanced written and verbal skills in English or French. Bilingualism, spoken and written, is preferred.
Senior Clinical Research Associate - NR 8

Purpose:

Works at senior level. Translates the overarching research program objectives into operational research projects. Responsible for overseeing ongoing research projects and/or a single major research project within the research program scope. Independently conducts and coordinates complex projects.

Typical tasks and duties:

Project and program development

  • Within a given research scope, conceptualizes, designs, implements, coordinates and monitors a program of research which may comprise multiple projects.

Management of research team

  • Hires, trains, supervises, manages, disciplines and terminates research staff.
  • Coordinates and conducts monitoring visits to collaborative sites.
  • Coordinates with lead investigators at multiple sites to assure timely and cost effective performance of the project.
  • Organizes teams and review meetings as necessary.

Project implementation, management and oversight

  • Supervises design and writing of protocols, case report forms and informed consent forms for research projects.
  • Reviews and approves research protocol / amendment(s), ethics protocols, and other project official documents including investigator brochures, reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios. Recommends final approval to Principal Investigator.
  • Plans, budgets and reports on research funds and their expenditure; authorizes payment of invoices.
  • Directs, plans and implements all activities required to conduct and monitor complex research projects and ensure that project protocols are followed.
  • Verifies that approved protocols and procedures are followed, including reporting of adverse events.

Subject recruitment and enrolment

  • Has overall responsibility to verify that the rights and well-being of human subjects are protected.
  • Oversees the identification, development, and implementation of effective participant recruitment strategies for the research projects.

Data collection and management

  • Has overall responsibility to ensure that the reported data is accurate, complete, and verifiable from source documents or samples.
  • Interacts with project team and data management personnel to ensure plan data capture, management and analysis.
  • Oversees data and sample collection and management.
  • Ensures that data management and internal reporting forms include appropriate efficacy and safety information Data analysis and interpretation.
  • Monitors data on an ongoing basis.
  • Monitors data for safety and efficacy trends.

Conduct of research project

  • Proactively addresses conduct issues and enrollment problems, as necessary.
  • Assures timely completion of studies.
  • Establishes and maintains relationships with project stakeholders to optimize performance of research program and projects.

 Assists with any other duties required by the research project or management of the research lab.

Knowledge, skills, education and experience:

  • Ph.D. in a relevant discipline and at least five years of practical experience as a senior researcher or M.Sc. with several years (5-7) of job-related work experience.
  • One to two years of management or project management experience.
  • Excellent organizational, leadership, problem-solving and analytical skills required.
  • Judgement in choosing best protocol/adapting procedures to meet changing needs.
  • Computer skills to aid in research, analysis and data presentation.
  • Excellent interpersonal, technical, scientific and communications skills (written/oral).
  • Ability to manage teams and people.
  • Advanced written and verbal skills in English or French. Bilingualism, spoken and written, is preferred.
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