Clin. Res. Project Manager-ri

3 weeks 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**:
We are looking for a Clinical Research Project Manager with excellent communication and organization skills to support our work for children and youth with various genetic variants associated with risk for autism and other neurodevelopmental disorders.

At SickKids’ Autism Research Unit (ARU), we run a clinic called “Developmental Assessment of Genetically Susceptible Youth (DAGSY). Children (age 1 to 18 years) are referred to the DAGSY clinic for a developmental assessment because they have been identified as carriers of genetic variants that are known to increase risk for atypical development (autism spectrum disorder, intellectual disability and other neurodevelopmental disorders). At DAGSY, we combine full clinical service with several scientific studies focused on elucidating the full breadth of neurodevelopmental trajectories associated with these genetic variants, as well as factors modifying these outcomes. The clinical service is multidisciplinary and consists of a developmental, cognitive, and academic assessment, as well as a psychiatric evaluation, based on which we provide families with a clinical report and recommendations.

As a Clinical Research Project Manager you will work closely with the Principal Investigator (PI) to plan and manage the overall research program and research team. This includes the long-term planning of on-going projects, day-to-day operations of on-going studies, and development of new projects. In addition, you will manage the personnel on the research team, comprised of clinical research coordinators and assistants, trainees and volunteers, including on-going training and supervision, conducting performance appraisals, and organizing communication strategies, and team meetings. Finally, you are expected to develop close working relationships with the medical and health care professional staff that provide clinical care to the study patients, both at the SickKids and other institutions.

**Here’s What You’ll Get To Do**:
**Clinical Aspects**:

- Maintain clinical files (paper and electronic format)
- Connecting families with available resources in their communities
- Act as primary contact for ARU, responding to inquiries from families and other healthcare providers
- Assist with administrative tasks related to clinic operation and research study initiatives
- Check patients in on clinic days via EPIC

**Research Aspects**:

- Carry out and assist in multiple research projects - including both local studies and international collaborations.
- Coordinate with study collaborators, PIs and clinicians to collect, transfer, and organize study data and biosamples; Oversee and coordinate acceptance of DNA samples from international sites
- Develop and amend study documents and SOPs based on regulations, REB templates and institutional requirements. Submit documents to REB and coordinate revisions, approvals and renewals
- Communicate with other study sites and participate in conference calls
- Oversee and coordinate legal contracts and agreements between sites, including yearly amendments and invoice processing
- Prepare yearly progress reports for studies including financial tracking and forecasting
- Keep abreast of regulations and policies governing clinical research and communicate to staff and research team members. (e.g., Tri-council Policy Statement, Good Clinical Practices).
- Develop policies and procedures related to the research program, ensuring external regulations and guidelines are followed.
- Develop and monitor timelines for existing studies, balancing the demands of multiple projects. Develop and maintain database of current studies and their status.
- Interview families and children using standardized questionnaires
- Coordinate with study collaborators, PIs and clinicians to recruit study participants, obtain informed consent.
- Participate in audits, site visits and monitoring by Sickkids and other regulatory bodies or sponsors.
- Maintain study databases, organize dat

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