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Clinical Research Coordinator ( part time casual)

Nutrasource
Guelph, ON

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Détails du poste

Temps partiel | Occasionnel
Il y a 13 jours

Compétences

Microsoft Powerpoint
Administration de médicaments
Recherche clinique
Tenue des dossiers
Classement
Amélioration des processus
Anglais
Capacités de présentation
Baccalauréat
Contrôle de la qualité
Recrutement
Gestion de budget
Procédures opératoires normalisées (PON)
Compétences en communication
Coordination d'équipe
Suivi de l'avancement des projets

Description complète du poste

Job Overview:

The Clinical Research Coordinator 1 (CRC 1) is responsible for research study activities such as assisting in study planning and set-up. They will be required to follow specific requirements of study protocols, regulatory requirements, policies, Standard Operating Procedures (SOPs) and Work Instructions (WI). The CRC 1 will also be required to recruit and coordinate research participants, as appropriate. This is a casual / part time role.

Primary Responsibilities:

Coordinates or co-leads assigned clinical research projects in accordance with Protocols, SOPs, WIs, and applicable regulations
Coordinates or co-leads BA and BE studies and assists with coordination of Phase 1 studies, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies and all phases of the studies as assigned
Acts as co-Lead CRC on studies, including planning and preparing for studies as follows:
Assists in review of assigned protocols and other protocol documentation (ICF, IB, electronic Case Report Forms (CRFs), Study Specific Procedures, Study Laboratory manual) for accuracy, feasibility, timing, and resources

o Assists the Recruitment team in pre-screening activities and recruitment of study participants

Assists in the preparation and maintenance of the Investigator Site File (ISF) for the study

o Participates in study start-up meetings (Investigator Meetings, Site Initiation Visits, Sponsor discussions, or other related meetings)

Assists in all required start-up activities including, but not limited to, the following:
Clinic logistics planning, schedule of clinic activities, and team training
Preparing clinic source collection documents, time and events tables, and other required study materials
Reviewing CRFs, laboratory workbooks, staff requirements, and schedules
In collaboration with the responsible teams, establishing and/or maintaining safety assessment requirements, Quality Control (QC) review, pharmacy/ dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study
Confirmation that all required regulatory and contractual documentation is present prior to study start
Planning and collaboration with vendors (safety laboratory, bioanalytic lab) for study set-up

§ Assists in monitoring budget allocation during the study and escalates as needed to the study lead

Performs the following during the conduct of a clinical trial:
Coordinates screening activities and provides support as required
Coordinates and ensures set-up of clinic rooms, participant chart review, and source document preparation prior to start of clinic activities
Assists and/or coordinates overall clinic activities including, but not limited to:
Assist in supervising clinic visits (admission, assist in dosing and randomization, discharge, and follow-up) as required.
Ensures volunteer eligibility prior to randomization.
Assists with and performs drug administration and other activities as delegated and required
In collaboration with the responsible teams, ensures that all study-related activities are conducted according to protocol, SOPs, WIs, and applicable regulations
Manages clinic updates, Adverse Event (AE) or Serious Adverse Event (SAE) reporting, study logs and trackers, quality control, and monitor findings
Assists with maintenance and updates to the Investigator Site File (ISF) accordingly
Escalates observations to Lead CRCs and Investigators as appropriate
Performs the following after the in-participant phase of the clinical study and in preparation for site close-out:
Ensures resolution and/or addresses QC, monitor, or other internal/external findings
Assists in close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation
Assists in updates of ISF documentation
Assists in finalizing the study and/or participant logs
Ensures completion of other close-out activities as required (return of study supplies, REB reports, archiving, etc.)

o Assists in the submission of participant reimbursement requests at the conclusion of their participation in the study

Monitors participants’ compliance throughout the study
Addresses day-to-day participant or study issues and escalates as appropriate
Prepares for regulatory inspections, sponsor or internal QA audits and monitoring visits
Provides accurate and timely project status updates to Lead CRCs
Collaborates within and between teams during process improvement exercises, SOP creation and/or revision, internal and external meetings, and other company-related initiatives and goals
Accommodates flexible schedules (available days, afternoons, nights, and weekends)
Minimal travel may be required (up to 25%)
Any ad hoc duties as assigned by Lead CRCs and Investigators

· Other duties as may be required and as training and experience allow

· Promotes GXP compliance across the organization

Maintains an attitude and philosophy consistent with the Company’s standards

Core Competencies:

Understands care of study participants, aspects of human subject protection and safety
Familiarity of Natural Health Product Regulations
Strong verbal and written communication skills in English (spoken and written)
Practices leadership and professionalism skills as well as understanding the importance of teamwork necessary for conducting a clinical trial.
Takes pride in accomplished task and observes accountability and ownership
Proficient in MS Office, Excel and Power Point
Good presentation skills are considered an advantage, but are not required

Education and Experience:

A minimum of a BA/BSc degree is required; a degree in a health, science or research related fields is preferred

· Pharmaceutical and/or clinical trial experience is preferred; specific therapeutic area experience is an asset for the position

Job Types: Part-time, Casual

Pay: $22.00-$30.00 per year

Work Location: In person

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Je souhaite recevoir la dernière alerte emploi pour les postes de ce type : admissions coordinator (guelph, on)

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