Clinical Research Associate 2, Gauteng based

Job Family Description

Monitors assigned sites to ensure that clinical research studies adhere to standard protocols and SOPs.

Sub-Family  Description

• Monitors during clinical research studies to ensure trials are being conducted in accordance with widely accepted clinical practices.

• Conducts on-site and remote monitoring using a combination of corporate and customer systems and tools to ensure quality monitoring

• Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

• Site field and remote monitoring visits for dedicated assigned sponsor(s) through direct customer interaction

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.

• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.

• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

• Collaborate and liaise with study team members for project execution support as appropriate.

• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.

• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications, Knowledge and Skills

• Bachelor's Degree Degree in scientific discipline or health care preferred.

• Requires at least 1 - 2 years of on-site monitoring experience.

• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).

• Good therapeutic and protocol knowledge as provided in company training.

• Experience in Inflammatory Bowel Disease (IDB) is an advantage

• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).

• Written and verbal communication skills including good command of English language.

• Organizational and problem-solving skills.

• Effective time and financial management skills.

• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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