Clinical Research Project Manager, Pscore Program

7 months ago

Toronto, Canada SickKids Full time

**About SickKids**:
Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and education. Our reputation would not have been built - nor could it be maintained - without the skills, knowledge and experience of the extraordinary people who come to work here every day. SickKids is committed to ongoing learning and development, and features a caring and supportive work environment that combines exceptionally high standards of practice.

When you join SickKids, you become part of our community. We share a commitment and determination to fulfill our vision of _Healthier Children. A Better World_.

Don’t miss out on the opportunity to work alongside the world’s best in paediatric healthcare.

**Position Description**:
**Clinical Research Project Manager**

The Clinical Research Project Manager will play a pivotal role in overseeing the coordination of a multi-centre international clinical trial called the Simple Bone Cysts in Kids study, while also demonstrating flexibility to meet the requirements of various projects within the PSCORE Program in the Child Health Evaluative Sciences (CHES) program at Sickkids. This role will report to two different Principal Investigators, ensuring seamless collaboration and alignment with the goals of both projects. The PSCORE Program is a patient-oriented research program focusing on understanding patient priorities, development of patient reported outcome measures, and the conduct of clinical trials and outcomes research involving acute and chronic musculoskeletal and neuromuscular conditions in children. This role will adapt to the diverse needs of these two distinct projects while maintaining a high level of coordination and efficiency.

**Here's What You'll Get To Do**
- Prepare protocols for use
- Develop case report forms and/or questionnaires
- Organize science reviews and track deadlines
- Keep abreast of regulations and policies governing clinical research and communicating to staff and research team members
- Develop policies and procedures related to the research program, ensuring external regulations and guidelines are followed
- Develop informed consent documents based on regulations, REB consent templates and institutional requirements. Submit documents to REB; following
- up on queries and changes. Prepare annual follow up for resubmission, making and submitting changes based on protocol amendments as required
- Develop study binders for clinical program and study team use and ensure they are kept up to date
- Participate in audits, site visits and monitoring by SickKids and other regulatory bodies
- Supervise literature reviews and keep current with study literature
- Supervise database development and entry and locking database once clean
- Develop programming to produce regular database reports
- Develop and monitor timelines for existing studies and balance the demands of multiple projects
- In multi-centre trials, manage the overall study, including participation in selection, training, monitoring and ongoing communication with other studies, and organizing Investigator meetings
- Develop training programs
- Develop quality control guidelines for studies - e.g. eligibility confirmation, protocol compliance, scheduling of re-evaluations
- Monitor serious adverse events or drug reactions and reporting to PI. Follow-up on adverse events including filing reports with internal and external regulatory bodies (REB), notification of collaborators, and/or patients
- Design/develop promotional strategies, including newsletters and letters to parents
- Oversee recruitment and patient contacts
- Encourage and foster collaborative relationships with the healthcare team at SickKids, other participating centres and government and community agencies
- Recruit, train and supervise project staff
- Actively participate in departmental/program meetings or rounds to acquire and disseminate knowledge and to profile clinical research
- Develop, manage and forecast study budgets
- Develop in-services on study requirements
- Monitor staff performance and assist PI with annual performance appraisals

**Here's What You'll Need**
- Master's degree in Epidemiology, Health Science or a related field with a minimum of three years experience in clinical research. Alternatively, you are a licensed healthcare professional with 5 - 7 years' related clinical research experience
- Certification as a clinical research associate (e.g., SOCRA accreditation) would be an asset
- Proven skills in grant writing, data and budget management
- Familiarity with statistical software packages
- Ability to function independently yet collaboratively within a team
- Effective communication, interpersonal, facilitation and project managemen

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