Type: Temporary full-time employment, annual renewable contract
Purpose of Position
Reporting to the VP, Research and Patient Programs, the Canadian IBD Research Consortium (CIRC) Research Project Manager is responsible for the coordination, management, and administration of CIRC’s clinical studies. This role will also report to CIRC’s Director of Research.
This position will require working collaboratively within the CIRC’s network of clinical sites and liaising with local site investigators to ensure the successful implementation of studies which will include site initiation; overseeing data collection, monitoring, and quality control; and working with local research personnel to achieve recruitment targets.
The successful candidate will develop and help facilitate templates to implement, monitor and be accountable for project protocols, operational plans, risk management, resources, project materials, documents and timelines, managing the day to day activities and performance of a multi-disciplinary project team, ensuring all decisions align with institutional and regulatory requirements.
Duties and Responsibilities
• Writing or contributing to preparation of clinical protocols, amendments, ethics submissions, informed consent forms, study guides, case report forms, and any other clinical research related documents;
• Assisting in training local research staff on study protocols and SOPs;
• Arranging site initiation visits;
• Developing and maintaining good working relationships with investigators and study staff;
• Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations (when applicable) and study-specific manuals and procedures;
• Identifying, selecting, and monitoring performance of investigational sites for clinical studies
• Investigating queries, monitoring discrepancies;
• Negotiating and managing study budget and the payments to individual study sites;
• Acting as the point of contact for all external and internal agencies;
• Understanding the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and coordinating any necessary audit processes;
• Creating and maintaining all trial files, including the trial master file, and oversight of site files;
• Assuring personal and confidential information is restricted to those entitled to access them;
• Reviewing key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with study team;
• Tracking and reporting on progress of study including site activation, patient enrollment, monitoring visits;
• Working with the Director of Research and Principal Investigators to ensure that the study is meeting its targets and producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time;
• Serving as liaison to individual project steering committees, data monitoring and safety boards (when applicable) and central IRBs (when applicable);
• Coordinating the preparation and publication of data, reports and information, ensuring that they meet legislative, contractual and ethical requirements;
• Performing clinical data review of data listings and summary tables, including query generation;
• Planning and conducting investigator meetings;
• Preparing investigator updates and other project related reports as required to support the proper conduct and execution throughout the life-cycle of assigned projects;
• Developing project communications, training, regulatory submissions, audits and third-party vendors as required.
• Works with the internal marketing and communications team to develop and implement strategy for knowledge translation, which may include promoting awareness of activities through creating web and social media content, program evaluation, and gathering and disseminating program updates;
• In consultation with the VP of Research and Patient Programs, identifies new potential funding opportunities to expand the program;
• Writes proposals for corporate sponsorship.
• Minimum: undergraduate degree in health or social sciences; graduate degree preferred;
• 3-5 years of clinical trial or human research project management experience involving multicenter studies;
• A background in/knowledge of clinical research with training in good clinical practices and research ethics;
• Superior interpersonal and communication skills, including the ability to act with tact, diplomacy, and professionalism, and handle sensitive information with discretion;
• Excellent organizational skills, including the ability to organize workload, set priorities and respond effectively to competing demands.
• Experience using project management tools;
• Experience with development of electronic case reporting forms using REDCap or equivalent;
• French communication skills.
• The working environment of the successful candidate will be negotiable. The candidate will have the option of working from a home office if s/he can fulfill the requirements of the position under such conditions.
• Some travel will be required.
Crohn’s and Colitis Canada provides a competitive salary and benefits program and a rewarding work environment. Interested applicants are asked to submit their resume and cover letter indicating salary expectations to email@example.com. Please quote "CIRC Project Manager" in the subject heading in your email reply. We thank all applicants for their interest; however, only those selected for interview will be contacted.