Lead Study Nurse Coordinator

2 weeks ago

Cape Town, Western Cape, South Africa TASK Full time

About the Company:


TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.


Overall Purpose of the Position:


The purpose of this role is to ensure that clinical trials are conducted according to protocol requirements at all times ensuring all procedures are documented in source and data is accurately transcribed onto clinical research forms (CRF) or electronic-CRF's.

In addition, this role supports the site manager by performing various staff and study management and administrative functions.

Key Performance Areas (KPAs) & Responsibilities include, but not limited to:

  • Planning ahead for new studies to ensure site readiness, including creating source documents, preparing files and ensuring clinical consumables and equipment are available for study start
  • Participating in the informed consent (IC) process by presenting a study to possible participants and/or family members
  • Assisting the investigator in signing the IC document and ensuring that adequate time and privacy for reflection and answering questions has been provided. Performing quality checks on ICF (informed consent form)
  • Assisting the investigator in verifying whether all inclusion and exclusion criteria are met before randomization
  • Performing study specific procedures in a protocolcorrect manner, within given timelines and in specified order, with the assistance of predrafted prompt sheets
  • Performing sputum collection (via sputum induction if needed)
  • Documenting procedure actual times and results directly and accurately in source documents
  • Administer IP as per protocol and keep the IP administration log up to date and verify storage is within allowed range as per protocol
  • Entering the source data timeously and accurately into electronic or paperbased case report forms (CRFs)
  • Ensuring the site files are always updated with latest study documentation at study start, during the study and at study close out
  • Assisting in addressing queries raised during monitoring visits, actively engage with Clinical Research Associate (CRA) and participate during exit meetings
  • Supporting the Sample Processing Room staff with various functions such as processing of samples and preparation for sampling
  • In the absence of the site manager, acts as the primary site resource/liaison by providing work direction to staff and/or assist with patient care and the daytoday provision of clinical services for the site including staffing, workflow, equipment and miscellaneous jobrelated duties.
  • Assisting the Site Manager with the delegated managerial functions
  • Assisting the Site Manager in the maintenance of the Quality Management System at site level
  • Proactively assisting with site training and meetings
  • Performing miscellaneous jobrelated duties as assigned

Ideal Requirements

  • Nursing degree or diploma
  • Valid Nursing Council certificate (SANC)
  • Valid ICH GCP certificate
  • Clinical trial experience
  • Supervisory/management experience would be an advantage
  • Computer and internet competency and basic knowledge of Microsoft Word, Excel, Outlook and Power Point
  • Valid Driver's License

Key Personal Inherent Characteristics

  • Excellent verbal and written communication skills
  • Excellent interpersonal skills
  • High attention to detail
  • Excellent follow up skills
  • Friendly
  • Planning and organising skills
  • Efficient
  • Ability to take initiative and is proactive
  • Flexibility to help out at all TASK sites and to accommodate regular weekend schedules

Details:

Area:
Bellville, Brooklyn, Delft, Cape Town

Contract Type:
Permanent

Applications Close: 21 June 2023

  • TASK reserves the right to withdraw this advertisement and not fill the abovementioned vacancy at any stage during the recruitment process._
  • Meeting our employment equity goals will be acknowledged during the recruitment process._

Job Types:
Full-time, Permanent

Application Deadline: 2023/06/21

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