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Clin. Res. Project Coord.-ri

3 months ago

Toronto, Ontario, 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

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 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 a Investigator initiated multi-national, multi-centered clinical trial 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 investigators portfolio.

Start Date:

ASAP

Description of Position:

CRPC study related responsibilities include, but are not limited to only these tasks:
Research Ethics Board, Regulatory, Industry Sponsor or Funders

Support Principal Investigator and Project Manager in

  • Preparation for audits, site visits and monitoring by SickKids and Regulatory Officials, and address all findings
  • 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 documents from the ethics board, regulatory etc.

Study Protocol and Manual of Operations

  • Read and have adequate 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
  • Liaise with all applicable departments to schedule research participants for study visits
  • Call and remind study participants of study requirements and appointments
  • Initiate and maintain a research chart for each research participant
  • Submit EPIC orders
  • Carry out study visits including patient assessments and interviews as required by the study protocol
  • Liaise with research support pharmacy to prepare and dispense investigational product or medicines for use at time of study visit as indicated in the protocol
  • Prepare and complete manual and/or electronic REDCAP CRF requirements
  • Handle and address all data queries
  • Inform PI of serious adverse events or reactions immediately, and Report adverse events according to Institutional Ethics Board, Health Canada and Sponsor (and/or DSMB) guidelines, as applicable.
  • Support Knowledge Translation Activities associated with Patient Engagement as part of the clinical trial and a requirement of Strategies for Patient Oriented Research (SPOR)

Laboratory
In collaboration with the research team

  • 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 will be provided.]

Data

  • Complete data entry for each study participant for each study visit (i.e., Source Documentation and REDCAP Data Entry)
  • Obtain investigator signature on study documentation
  • Update study tracking logs

Qualifications:

  • A Master's degree in Epidemiology, Health Science or a related field with a minimum of 3 + 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).
  • Experience in handling human biological samples with care and ensuring samples are processed and labeled accurately as well as documented in logs and stored properly is also an asset
  • Possesses current knowled