Clinical Research Manager

The Clinical Research Manager will manage and coordinate multi-centre investigator-initiated clinical research projects. In addition, they will run the day to-day research activities related to study participant enrolment, biological material sampling, maintenance of regulatory documents and all relevant data; provide supervision and training to research assistants and summer students; and perform other related duties as required. The Project Coordinator will consult with PIs and assist with coordination of investigator initiated studies, including protocol development, ethics and contracting.

The Clinical Research Manager will report to directly to the CEO

**COMPANY OVERVIEW**

Black Tusk Research Group is a Site Management Organization (SMO) located in downtown Vancouver that specializes in operating clinical research for hospital-based investigators. This ranges from carrying out specific duties of the project including design, start-up, budgeting, financial reporting, recruitment, data collection, and study close out, to project managing from start to finish. Professional integrity and patient centered care are among our core values. We provide efficient and optimal regulatory, administrative, and project management support for clinical investigators within the Respiratory Division, Healthy Heart Clinic, Critical Care (Intensive Care unit), Pathology and the UBC Centre for Heart Lung Innovation at St. Paul’s Hospital. Our group manages both academic-grant funded and pharmaceutical/biotech funded studies, involving drugs and devices ranging across many disciplines: respiratory diseases including Chronic Obstructive Pulmonary Disease (COPD) (bronchitis and emphysema), asthma, idiopathic pulmonary fibrosis (IPF), cystic fibrosis (CF), as well as cardiovascular disease research, acute illnesses such as sepsis and pneumonia, and many others. This support runs the full gamut from trial initiation through study close-out.

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**JOB SUMMARY**

The Clinical Research Manager will manage and coordinate multi-centre investigator-initiated clinical research projects. In addition, they will run the day to-day research activities related to study participant enrollment, biological material sampling, maintenance of regulatory documents and all relevant data; provide supervision and training to research assistants and summer students; and perform other related duties as required. The Project Coordinator will consult with PIs and assist with coordination of investigator initiated studies, including protocol development, ethics and contracting.

**RESPONSIBILITIES AND DUTIES**
- Participating in project development, planning and execution;
- Developing work priorities for research projects, setting timelines and ensuring research objectives and deadlines are met
- Attending meetings to define strategy, goals, and scope of a research project
- Assisting Principal Investigators in the development their research programs: research design, modification and protocol development
- Providing input into recruiting participants, conducting surveys, and extracting data;
- Assisting in development of informed consent forms, data collection case report forms, and recruitment materials
- Participating in study planning and execution to ensure research is conducted according to study protocols
- Hire and manage Study Coordinators and Research Assistants
- Developing budgets for projects and holding their staff accountable to project completion without falling into deficit
- Maintenance and distribution of study drug supply and inventory
- Liaising with sites and coordinating and tracking study team training and activities, participant enrolment, maintenance of study documents, data collection, etc.
- Maintain professional levels of communication at all times, to strengthen existing collaborations with research
- Clinical chart review and screening for eligibility of potential study participants
- Obtaining informed consent from research participants or substitute decision maker
- Coordinating study procedures and participant's study visits
- Coordinating acquisition of data from multiple sources and individuals
- Developing numerous organizational and study specific Standard Operating Procedures (SOP)
- Responsible for maintaining the accuracy, accessibility, and confidentiality of study files and regulatory documents

**QUALIFICATIONS AND SKILLS**
- Master’s degree or higher in a relevant discipline.
- Minimum of two years’ experience in clinical research or project management preferred.
- Extensive experience with UBC's Researcher Information Services system (RISe) preferred.
- TCPS certified preferred.
- GCP training preferred.
- SoCRA certification (CCRP) preferred.
- Transportation of Dangerous Goods and Handling Training preferred.
- Administrative experience, skills and knowledge in research coordination.
- Knowledge of and experience in qualitative data collection. Experience working with people in a heal