Clinical Research

2 weeks ago

Cape Town, 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 clinical research QA Manger (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 (QA) Manual and a research Site Quality Manual. 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 also ensures that the protocols of various studies and the TASK research Site Quality Manual (SQM) is implemented by all TASK sites according to the study budgets.

When TASK is taking on the role of a Contract Research Organization (CRO) or Sponsor the CR-QAM may be responsible to perform internal monitoring and / GCP audits and help create, implement and oversee the implementation of monitoring plans executed by contracted external monitors within the allowed budget.

**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 in order to identify the possible need for SOP and / or staff training 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. Manage 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 proof 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.
- Sharing the workload across the team, offering support to ensure that QA key indicators are monitored, and trends are identified and reported. Ensuring regular feedback on overall QA/QC status of TASK to QA Head (QAH).
- Managing the QA feedback during Friday operational meetings.
- Assisting in planning and conducting internal audits on protocols, systems, procedures and other QA and QC activities and document outcome, analyse data to identify areas for improvement.
- Investigating and overseeing customer / sponsor complaints and non-compliance issues and reporting to QA Head.
- Investigating, overseeing and managing company and protocol risk mitigation 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).
- Assist in 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 feed back to QAH or sponsors.
- 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 doing performance appraisals if needed.
- Contributing to hiring decisions, when required.
- Performing miscellaneous job-related duties as assigned.

**Ideal Requirements**
- Bachelors or BSc degree preferred
- Valid GCP certificate
- Knowledge and experience in Clinical Research
- 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 Re

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