Clinical Research Associate (South Africa) at Global Antibiotic R&D Partnership (GARDP)

Description

The CRA is responsible for conducting project activities associated with the monitoring functions of Phase I-IV clinical studies while continuing to develop his/her knowledge of the drug development process, Good Clinical Practices, and relevant regulations.

The CRA manages investigator site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines, study documents (including protocol and plans) and Standard Operating Procedures (SOPs).

The CRA is the first point of contact for investigators and site staff and will maintain regular contact with study site to ensure GCP/ICH/Protocol compliance, assessment of subject accrual rates and respond to internal team requests.

The CRA is involved in the coordination, support and documentation of projects throughout all stages of the development process, with particular focus on the clinical phases. As a CRA, S/he will report to the GARDP CTM at project level and be responsible for monitoring and keeping track of GARDP resources for given projects.

Requirements

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines and protocol requirements

• Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, review data and ensure accuracy of data collected and to close-out studies

• Provides regular clinical status information to team members and project management

• Performs work in accordance with company policies, procedures, and Standard Operating Procedures

• Works closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff.

• Communicate project-specific information to/from trial sites and documents communication with study site/ team in a timely manner. Escalates issues to CTM in a timely manner

• Monitors project schedules and budgets with the Trial Manager/Project Leader and the partners

• Performs source document verification, retrieves Case Report Forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety reporting at investigative sites

• Ensure proper storage, dispensation, and accountability of all investigational product(s) and trial related material, including biological samples

• Reviews adverse event reports (AE/SAE) and ensures the site is reporting the events appropriately according to project specifications

• Collects any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements

Performs investigative site file reconciliation

• Documents monitoring activities in monitoring reports and follow-up letters. Communicates serious issues to the CTM in a timely manner

• Responds to requests from investigative sites in a timely fashion

• Provides support to investigative sites to facilitate payments

• Assists in or perform EC submissions and follow this process to approval

• Supports or performs the CA / Health Authority submissions if required, and follow this process to approval

Ensures projects follow GCP and regulatory compliance and keep appropriate documentation

• Participates in developing a quality management system and developing / reviewing SOPs
  Assist with the submission of documents to the Regulatory Authority and/or Ethics Committees

• Collects, reviews and tracks essential/regulatory documents

• Collects data and information to enable Project teams and management to make effective and cost-efficient use of DNDi/GARDP resources

• Regular interaction with partners / CROs / study site teams to ensure that projects meet their milestones

• Provides logistical support and tracking for all trial materials with partners, CRO and other members of the project team

• Provides progress reports to CTM / study team on individual projects

• Assists in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews

• Develops and maintains the skills required for delivery of all aspects of clinical trials

• Maintains awareness of developments in the designated projects that relate to drug development

• To be aware of developments in clinical development and the regulatory environment, and report these to DNDi/GARDP

• To be familiar with pharmaceutical regulatory requirements, documentation and processes for major international agencies

Performs all types of onsite visits (PSV, SIV, IMV, COV) and may be involved in co-monitoring visits:

Ensure regulatory compliance for projects

• Assists in or perform EC submissions and follow this process to approval

• Supports or performs the CA / Health Authority submissions if required, and follow this process to approval

• Ensures projects follow GCP and regulatory compliance and keep appropriate documentation

• Participates in developing a quality management system and developing / reviewing SOPs
  Assist with the submission of documents to the Regulatory Authority and/or Ethics Committees

• Collects, reviews and tracks essential/regulatory documents

Manage and develop project reporting systems

• Collects data and information to enable Project teams and management to make effective and cost-efficient use of DNDi/GARDP resources

• Regular interaction with partners / CROs / study site teams to ensure that projects meet their milestones

• Provides logistical support and tracking for all trial materials with partners, CRO and other members of the project team

Enable review of projects

• Provides progress reports to CTM / study team on individual projects

• Assists in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews

Attends / presents at investigator meetings and other study meetings as required.

Participates in feasibility assessments and supports CTM by assessing project feasibility and support ad hoc requests for feasibility

May be assigned Lead CRA accountabilities on non-global studies and provide back up for the CTM to address sponsor or site queries

May serve as a resource for and interact with other functional areas to resolve site issues and facilitate project timelines

Additional /specific/projects responsibilities

• Develops and maintains the skills required for delivery of all aspects of clinical trials

• Maintains awareness of developments in the designated projects that relate to drug development

• To be aware of developments in clinical development and the regulatory environment, and report these to DNDi/GARDP

• To be familiar with pharmaceutical regulatory requirements, documentation and processes for major international agencies

Support for Project teams and DNDI GARDP Southern Africa office objectives

• Play a full role in the GARDP R&D team and to be an active member of the GARDP global team, as well as the DNDi GARDP Southern African team

• Help to build long term relationships with key research centers and individual investigators to support GARDP and Southern Africa office’s objectives and presence in the region

The job description may include additional individual duties and responsibilities not listed in detail but still expected to be reasonably performed

Core Skills and Attributes

• Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines

• Clear and systematic thinking that demonstrates good judgment and problem-solving competencies

• Very Good communication skills in multicultural, multi-lingual environments

• Ability to work effectively as part of a multicultural team

• Well organized and structured, with very good analytical skills

• Ability to contribute to the project delivery under minimum supervision

• Ability to manage middle sized projects with budget management under supervision

• Provide specialist services to operational line or project team

• Ability to solve non-routine problems on a case by case/project basis

• Has certain autonomy for taking actions and decisions

• Ability to interact with external stakeholders

• Ability to be the focal point/manager for consultants

• Ability to supervise at a smaller level

• Must have high degree of accuracy and attention to detail

• Knowledge of GCP and its application in clinical trial conduct

• Good understanding of Medical Terminology

• Undergraduate degree in a clinical, scientific, or related field or its international equivalent, or equivalent work experience required

• An advanced degree (e.g., MSc., PharmD, etc.) preferred

R& D Technical Skills

• Knowledge of GCP and its application in clinical trial conduct

• Good understanding of Medical Terminology

DNDI GARDP Southern Africa Leadership Competencies

• Forward thinking

• Respect

• Reliability

• Recognition

• Care

• Effectiveness

Experience

• Minimum 2 years’ relevant experience in clinical research –

• Proven ability to work effectively in a team environment and matrix structure

• Read , write and speak fluent English

• Fluency in other African language will be an advantage

• Knowledge of ICH and local regulatory authority regulations regarding drug research and development required

• Good knowledge of Microsoft Suite

• Valid driver’s license

• Willingness to travel to other African countries

• Up to 50% work travel required

• Fully remote , Cape Town, Johannesburg or Durban based

• Please submit your application using the online form

• Deadline for application: Accepting applications until 16 February 2022

Education

• Undergraduate degree in a clinical, scientific, or related field or its international equivalent, or equivalent work experience required

• An advanced degree (e.g., MSc., PharmD, etc.) preferred

Other Requirements

• Read , write and speak fluent English

• Fluency in other African language will be an advantage

• Knowledge of ICH and local regulatory authority regulations regarding drug research and development required

• Good knowledge of Microsoft Suite

• Valid driver’s license

• Willingness to travel to other African countries

• Up to 50% work travel required

• Fully remote , Cape Town, Johannesburg or Durban based

• Please submit your application using the online form

• Deadline for application: Accepting applications until 16 February 2022

• Only shortlisted candidates will be contacted

Location

• Fully remote , Cape Town, Johannesburg or Durban based

• Please submit your application using the online form

• Deadline for application: Accepting applications until 16 February 2022

• Only shortlisted candidates will be contacted

To apply

• Please submit your application using the online form

• Deadline for application: Accepting applications until 16 February 2022

• Only shortlisted candidates will be contacted

Benefits

Remuneration

• R36000pm – R40000pm plus benefits ( South African Rand )

• Benefits include healthcare and provident fund