CLINICAL RESEARCH GENERIC TASK DESCRIPTIONS

Transcription

1 Purpose Purpose Purpose Primary responsibility for implementation, coordination, evaluation, communication and/or management of research studies. May involve more than one study or multiple sites within a study. 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) 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 Typical tasks and duties Typical tasks and duties Project preparation Conducts detailed operational preparation of research project including schedules, progress, coordination, deliverables, milestones of the project 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 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 Implements the project foundation - the planning, assembling and instruction of the project team, development and evaluation of subject information and informed consent forms and development of subject recruitment strategies Develops reporting tools for deviations from the currently approved protocol / amendment(s), with ethical approvals, Good Clinical Practice (if required), and with applicable regulatory requirements. Prepares regulatory and ethical submissions and procedures for communicating with relevant authorities Completes other project initiation deliverables, including development of documents, standard operating procedures, tools, organization, etc. Develops strategic approach for networking and stakeholder management 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 1 P age

2 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. Participates in budget development and preparation; Management of research personnel Recruits project staff, including study nurses; ensures that all research staff have adequate qualifications for the conduct of the study Supervises recruitment/interviewing/selection, orientation and training of new project staff Supervises research staff, assistants, students and volunteers Evaluates performance of research staff, assistants, students and volunteers Project implementation, management and oversight Executes, monitors and conducts research projects safely, including assessment of progress against milestones and financial monitoring, Ensures effective deployment of project human, financial, and technical resources. Manages budgets and, in coordination with Faculty administrative teams and Financial Services, prepares financial reports. 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) Manages operations and information systems. Ensures that the project is conducted in accordance with the currently approved protocol 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 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; Has overall responsibility to ensure that the reported data is accurate, complete, and verifiable from source documents or samples 2 P age

3 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; 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 research project or management of the research lab. / amendment(s), with ethical approvals, Good Clinical Practice (if required), and with applicable regulatory requirements. Ensures that deviations are reported to the Principal Investigator. Oversees management of adverse event reporting. Ensures effectiveness and integrity of patient recruitment processes Ensures that the rights and well- being of human subjects are respected and protected Participates in subject recruitment processes as needed Oversees data and sample collection and management Ensures that source data/documents and other trial records are accurate, complete, and maintained Ensures that samples and specimens are accurately catalogued and properly stored Ensures that reported data is accurate, complete, and verifiable from source documents Participates in data collection and management processes as needed Oversees data analysis and interpretation Conducts sophisticated and/or advanced data 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 Monitors data on an ongoing basis Monitors data for safety and efficacy trends 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 research project or management of the research lab. 3 P age

4 analyses and interprets results Carries out sophisticated, complex, and/or higher risk tests, experiments, and procedures which may require specialized expertise and experience 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. Identifies and troubleshoots research questions or problems which affect the conduct of the project and/or the participation of research subjects and providing leadership in resolving the situation. Especially complex and /or unresolved issues are referred to supervisor Prepares key documents including ethics applications, manuscripts for publication, project reports, abstracts, scientific posters and presentations, etc. Participates in identifying and applying for additional funding Liaises with the lab, project partners, network participants, sponsors, government and external agencies etc. research project or management of the research lab. 4 P age

5 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. Knowledge, skills, education and experience Undergraduate degree in health sciences, biomedical or a related discipline; graduate degree is preferred;. Professional designation appropriate to the field (e.g. RN, Registered Dietitian, etc.) 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 Deep knowledge of research methodologies and, where applicable, Good Clinical Practice (GCP) 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. 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. 5 P age