Careers

Clinical Research Quality Assurance Manager 

Overall Purpose of the Position: 

The clinical research QA Manager (CR-QAM) will create, maintain and oversee the implementation of the TASK Clinical Quality Management System (QMS) (as applicable to the research sites) comprising of a Quality Assurance Manual (QAM) and a research Site Quality Manual (SQM). The CR-QAM references and implements tasks as described in the QA Manual, Good Clinical Practice (GCP) and TASK Standard Operating Procedures (SOP’s) for day-to-day operations and ensures that the protocols of various studies and the TASK research SQM is implemented by all TASK sites according to the study budgets.

When TASK is taking on the role of a Site Management Organisation (SMO) and / or Sponsor the CR-QAM may get involved and be responsible to perform internal monitoring and / conduct GCP audits at the sites and /or  help draft a sponsor monitoring plan, get quotes and contract external monitors (alias CRAs) within the allowed budget and oversee the implementation of the plan as well as other sponsor responsibilities as guided by good clinical practice(GCP) guidelines.

 

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

  • Attending investigator meetings (IM) and/or site initiation visit (SIV) to ensure a thorough knowledge and understanding of study protocols and expected procedures and requirements to identify the possible need for SOP and / or staff training delegation or to implement systems.
  • Reading and analysing protocols, SOP’s and manuals.
  • Drafting and maintaining the clinical QA Manual, audit tools and research Site Quality Manual (SQM).
  • Conducting an annual review of the QA Manual and SQM to analyse the implementation and efficiency of quality and inspection systems and tools and discussing with QA Head (QAH) for final approval and roll out.
  • Assisting QAH in drafting TASK SOP’s and policies as required as well as study specific SOP’s / policies when requested.
  • Ensuring SOP’s/policies stay current by assisting QAH in reviewing and updating SOP’s within three years after approval date or as processes change or new information becomes available. Managing SOP distribution system and training on them.
  • Assisting in identify training needs, implement, coordinate via internal or external programs and maintaining clinical training modules and tracking records to ensure current records for training of staff to prove qualification (non-protocol specific) and competency as per job description and delegated tasks.
  • Assisting with coordinating and scheduling / overseeing relevant clinical equipment services when needed and coordinate annual calibration of all clinical equipment by maintaining a system to control, replace, receive, and distribute equipment and calibration certificates between sites and maintain an equipment inventory list per site and TASK overall.
  • Assisting in planning and conducting internal /sponsor audits on protocols, systems, procedures and other QA and QC activities and document outcome, analyse data to identify areas for quality improvement (QI).
  • Assisting with duties when TASK is delegated as the Sponsor of a trial.
  • Assisting with developing monitoring plans according to protocol and budgets.
  • Obtaining quotes for external monitoring services.
  • Oversight of external monitors – ensure adherence to monitoring plan and timelines, review reports and provide feedback to QAH or sponsors.
  • Investigating, overseeing, and managing company and protocol risk mitigation and reporting to QA Head.
  • Investigating and overseeing customer / sponsor complaints and non-compliance issues and reporting to QA Head.
  • Assisting sites in audit preparations, coordinate and support site during external audits.
  • Evaluating audit findings and implement appropriate corrective and preventative actions (CAPA).
  • Sharing the workload across the team, offering support to ensure that QA key indicators are monitored, trends are identified and reported. Ensuring regular feedback on overall QA/QC status of TASK to QA Head (QAH).
  • Providing professional guidance to team members with complex issues.
  • Assisting in drafting clarifying MEMO’s and / or Note to file when needed and ensure record keeping thereof as well as record of any general QA findings.
  • Ensuring QA job descriptions are current and implemented by conducting performance appraisals if needed.
  • Contributing to hiring decisions, when required.
  • Performing miscellaneous job-related duties as assigned.
  • Joining TASK Academy in course development and providing training and / or share good clinical practice (GCP) and good clinical lab practice (GCLP) knowledge as a subject matter expert if and when required.
  • Managing the QA and Academy feedback during Friday operational meetings.

 

Ideal Requirements

  • Bachelors or BSc degree in any health sciences preferred.
  • Valid GCP certificate
  • Knowledge and experience in Clinical Research will be an advantage.
  • Two to four years’ working experience as a monitor (CRA) / in a quality assurance role will take preference.
  • Three to five years’ experience in a management role within the related pharmaceutical industry or Contract Research Organisation (CRO) would be an advantage.
  • Demonstrated experience in implementing quality assurance systems and assessing processes and identifying needs within Clinical Trials.
  • Knowledge of current GCP guidelines and regulations, and other regulatory requirements will be to your advantage.
  • Strong computer skills including Microsoft Office, Word and Excel, PowerPoint.

 

Key Personal Inherent Characteristics

  • Self-management
  • Internal motivation, take initiative, a proactive attitude.
  • Judgment calls and decision making
  • Attention to detail
  • Excellent communication skills – verbal and written (report writing), presentation skills
  • Data collection, management and analysis thereof
  • Problem analysis and problem solving, planning and organizing
  • Flexibility, adaptability and continuous learning
  • Team player
  • Taking initiative
  • Working independently

 

Details:

Area: Parow, Cape Town

Contract Type: Permanent

Applications Close: 13 February 2023    

Send applications to vacancies@task.org.za

Please indicate in your application that you are applying for the above-mentioned position.

If you have not received a response within two weeks, your application was most likely unsuccessful.

TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.

Meeting our employment equity goals will be acknowledged during the recruitment process.

By responding to this advert and sending your cv, cover letter and/or any other documentation, you are consenting to TASK processing your personal information as contained in the furnished documents. TASK may process your personal information for recruitment purposes for suitable posts that may arise within the organisation. You agree that you have familiarised yourself with South Africa’s Protection of Personal Information Act and understand your rights and obligations under this Act.

Study Nurse Coordinator

Overall Purpose of the Position: 

The purpose of this role is to perform procedures following the visit schedule as stipulated in each protocol and monitor the health and safety of the participants, and document the response to an intervention, which is typically new drug or therapy in the source documents. The Study Nurse Coordinator will be responsible for specialized nursing activities such as phlebotomy, taking of vital signs, symptoms procedures, ECG measurement, administering oral and IV medications, injections, cannulation, and holistic patient care.  The Study Nurse Coordinator ensures that the clinical trials are run according to protocol and Good Clinical Practice (GCP) 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.

 

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

  • Undertaking of the informed consent (IC) process by presenting a study to possible participants and/or family members.
  • Preparing participants for study. Educating, caring for and supporting the study participants throughout the course of the trial
  • Assisting the investigator in signing of 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 lead study nurse/nursing manager with scheduling of study participants. Making relevant appointments for study participants, liaising with City of Cape Town and provincial government clinic staff
  • Assisting the investigator in verifying whether all in- and exclusion criteria are met before randomization.
  • Ensuring optimal subject preparation, care and safety always for all subject visits
  • Planning ahead and performing study specific procedures in a protocol-correct manner and within given timelines and in specified order, with the assistance of pre-drafted source documents; Document patient care and procedures in pre-drafted source documents.
  • Completing source documents, logs and checklists accurately and in real time according to GCP specifications. Reviewing source documents for accuracy and completeness
  • Ensuring subject safety, protocol compliance and always preventing protocol deviations
  • Familiarizing themselves with normal ranges in vital signs, ECG measurements, safety blood ranges, in order to identify abnormalities and act/document accordingly to ensure subject safety.
  • Collecting biological specimens (sputum, saliva, blood, etc.), preparing specimens and completing any related documents, logs and checklists accurately and in real time according to GCP specifications.
  • Documenting procedure actual times and results directly and accurately in source documents
  • Administering Investigational Product (IP) as per protocol and keeping the IP administration log up to date and verifying storage are within allowed range as per protocol.
  • Entering of source data timeously and accurately into electronic or paper-based case report forms (CRFs)
  • Performing miscellaneous job-related duties as assigned
  • Being competent in professional registered nursing procedures including, but not limited to, vital signs, ECG measurements, phlebotomy, IV preparation, administration and monitoring, medication administration and control as well as resuscitation procedures.

 

Ideal Requirements

  • Nursing degree or diploma (Registered nurse)
  • Valid Nursing Council certificate (SANC)
  • Valid ICH GCP certificate
  • Valid BLS certificate/equivalent would be advantageous
  • Valid HIV Counselling certificate/equivalent would be advantageous
  • Previous experience in Clinical trials (Advantageous)
  • Computer literacy – ability to use Word, PowerPoint and Excel at intermediate level.
  • Valid Driver’s License
  • Flexibility to work at other TASK sites and to accommodate occasional night and weekend schedules (Brooklyn Primary site).

 

Key Personal Inherent Characteristics

  • Excellent verbal and written communication skills
  • Excellent inter-personal skills
  • High attention to detail
  • Excellent follow up skills
  • Friendly
  • Planning and organising skills
  • Efficient
  • Has initiative and is proactive

 

Details:

Area: Brooklyn, Cape Town

Contract Type: Permanent

Applications Close: 8 February 2023    

Send applications to vacancies@task.org.za

Please indicate in your application that you are applying for the above-mentioned position.

If you have not received a response within two weeks, your application was most likely unsuccessful.

TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.

Meeting our employment equity goals will be acknowledged during the recruitment process.

By responding to this advert and sending your cv, cover letter and/or any other documentation, you are consenting to TASK processing your personal information as contained in the furnished documents. TASK may process your personal information for recruitment purposes for suitable posts that may arise within the organisation. You agree that you have familiarised yourself with South Africa’s Protection of Personal Information Act and understand your rights and obligations under this Act.