Clinical Trial Assistant

**Job Overview** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. **Essential Functions** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...

Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

Typical Accountabilities Assists in coordination and administration of clinical studies from the startup to execution and closeout. Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents. Serves as local administrative main contact and works closely...

**Summary of The Position**: The Medical Writing Manager is tasked with the writing of trial-related documentation for clinical projects undertaken by the Company in accordance with ICH GCP and local legal requirements, European, FDA and other international guidelines, as well as Company (and sponsor, if applicable) Procedural Documents. The Medical Writing...

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

Summary of The Position:The Medical Writing Manager is tasked with the writing of trial-related documentation for clinical projects undertaken by the Company in accordance with ICH GCP and local legal requirements, European, FDA and other international guidelines, as well as Company (and sponsor, if applicable) Procedural Documents. The Medical Writing...

**Job Advert Summary**: Applications are invited for the above-mentioned position, to be filled as soon as possible. **Minimum Requirements**: - Nursing qualification. - Clinical Auditing experience - Minimum of 2 years' experience in the managed care environment **Duties and Responsibilities**: - Conduct clinical audits on claims and costs to ensure...

Clinical Data ManagerSouth Africa | Remote DFnet provides data management, biostatistics, and software development services for industry, nonprofit, and academic organizations worldwide. Since 2004, DFnet's people, products, and services have helped our global clients with over 100 Phase I through Phase IV clinical trials. Our focus is global health. DFnet...

Job Advert Summary:Applications are invited for the above-mentioned position, to be filled as soon as possible.Minimum Requirements: Nursing qualification. Clinical Auditing experience Minimum of 2 years' experience in the managed care environmentDuties and Responsibilities: Conduct clinical audits on claims and costs to ensure correct payment of claims to...

Advert Reference: P8913 Project Co-Ordinator: Trial Setup Job Title: Project Co-Ordinator: Trial Setup Closing Date: 2024/02/09 Position Available From: 2024-02-02 Area: Centurion Actual Place Of Work: Centurion Position Type: Full-Time Weekly Hours: 40 Time Conditions: 5 day Work Week (South Africa) Purpose of Position: To set-up trials according...

**Clinical Data Manager** **South Africa | Remote** - DFnet provides data management, biostatistics, and software development services for industry, non-profit, and academic organizations worldwide. Since 2004, DFnet’s people, products, and services have helped our global clients with over 100 Phase I through Phase IV clinical trials. Our focus is global...

Advert Reference: P10399 Project Co-Ordinator: Data Management: Clinical Trials Job Title: Project Co-Ordinator: Data Management: Clinical Trials Closing Date: 2024/03/04 Position Available From: 2024-02-26 Area: Centurion Actual Place Of Work: Centurion Position Type: Full-Time Weekly Hours: 40 Time Conditions: 5 day Work Week (South Africa) Purpose...

Advert Reference:P8913 Project Co-Ordinator: Trial SetupJob Title:Project Co-Ordinator: Trial SetupClosing Date:2024/02/09Position Available From:Area:CenturionActual Place Of Work:CenturionPosition Type:Full-TimeWeekly Hours:40Time Conditions:5 day Work Week (South Africa)Purpose of Position:To set-up trials according to the trial requirements and to ensure...

You will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. The role may also include maintenance activities. This is not a line management position but requires...

You will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. The role may also include maintenance activities. This is not a line management position but requires...

Summary of the Position: The TMF Specialist I is responsible to complete quality reviews of trial master file (TMF) documents for the purposes of audit and regulatory and health authority inspection readiness, and for ensuring compliance as determined by FHI Clinical processes, trial sponsors, and the applicable institutional policies from the startup phase...

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...

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...

**Essential Functions**: - Expected to be the accountable point of contact for designated clients, responsible not only for RA deliverables but also for proactive communication and budget adherence. - Act as the Lead Regulatory Professional for regulatory projects awarded to FHIC, with support from other senior colleagues. - Provides Clinical Research...