Clinical Research Project Coordinator, Division of Endocrinology

2 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**:
**Employment Type**: Temporary Fixed-Term (0.8 FTE), 1 year contract with potential for renewal

**Hours of Work**: 35 hrs per week (1.0 FTE)

**Department/ Division**: Division of Endocrinology

The Division of Endocrinology is in search of a full-time senior and experienced Clinical Research Project Coordinator (CRPC) to work closely with the Principal Investigator (PI) and Senior Project Manager to coordinate the day-to-day operations of Investigator initiated multi-centered observational studies and clinical trials in pediatric diabetes, while working synergistically with research team members locally and at clinical trial sites. The CRPC may also be asked to engage in other studies as part of the investigator's portfolio.

**Start Date**: February 2025

**Here's What You'll Get To Do**:
**Research Ethics Board, Regulatory, Industry Sponsor or Funders**:

- Preparation for audits and monitoring by SickKids and Regulatory Officials, respectively and as applicable, and address all findings that arise from these type of visits
- Contribute to preparation of study progress reports for Data Safety Monitoring Board, DSMB and/or Funders, as applicable
- Keep up to date regarding regulations and policies governing clinical research
- Up-keep of essential study documents related to ethics board, regulatory etc.

**Study Protocol, Standard Operating Procedures & Manual of Operations**:

- Read and have in-depth knowledge of protocol and standard operating procedures as outlined in the manual of operations

**Research Participants**:
In collaboration with the research team:

- Identify eligible patients
- Recruit eligible patients
- Obtain Informed Consent/ Assent (Virtual and In-Person, Diabetes Clinic)
- Liaise with applicable departments to schedule research participants for study visits
- Schedule participants for virtual recruitment/ consent and study visits
- Call and remind study participants of study requirements and appointments
- Initiate and maintain a research chart (i.e., paper based and/or electronic) for each research participant
- Submit EPIC orders
- Carry out study visits including patient assessments and interviews as required by the study protocol
- Complete and keep up to date study logs
- Liaise with research support pharmacy to have investigational product or medicines dispensed to study participants as indicated in the protocol
- Knowledge of Serious and Non-Serious Adverse Events (SAEs and AEs), Completion and Reporting of SAE and AE Forms according to Institutional Ethics Board, Health Canada and Sponsor (and/or DSMB) guidelines, as applicable.
- Lead Knowledge Translation and Patient Engagement Activities associated with studies funded in our Diabetes Research Program.

**Laboratory**:
Oversee laboratory operations with research team support to:

- Submit Epic Orders for lab tests
- Process and centrifuge urine and serum samples
- Keep laboratory logs up to date
- Ship and receive lab samples to and from collaborators and service providers
- Organize and store samples in freezers
- Aliquot samples for analysis
- Order lab supplies required for studies

[Training on handling human biological samples as per institutional guidelines will be provided.]

**Data**:

- Complete data entry for each study participant for each study visit (i.e., Source Documentation and REDCAP Data Entry)
- Generate Data Queries
- Address and Resolve Data Queries
- Obtain investigator signature on study documentation

**Here's What You'll Need**:

- BSc or MSc in Health Sciences or a related field with a minimum of 5 + years' experience in clinical research, with human clinical/ medication trial experience preferred (i.e., considerable experience with patient recruitment, ethics and regulatory bodies and other hospitals).
- A clinical professional degree would be an asset, as would certification as a clinical research associate (e.g., SOCRA accreditation).
- Valid driver license to commute to clinical trial sites
- Certification (i.e., tra

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