cFSP_SrCRA1_Novartis_Ghana_FSP-2021102842 at IQVIA

Accra, Greater Accra Region, Ghana

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

High School Diploma or equivalent; Degree in scientific discipline or health care preferred
At least 2 years of on-site monitoring experience
Equivalent combination of education, training, and experience may be accepted in lieu of degree
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
Computer skills including proficiency in use of Microsoft Word, Excel, PowerPoint, laptop computer, 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

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice
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) of 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, support development of project subject recruitment plan on a per site basis
If applicable, manage site financials according to executed clinical trial agreement and retrieve invoices according to local requirements

Skills

Key technologies and capabilities for this role

GCPSite MonitoringProtocol TrainingSubject RecruitmentRegulatory SubmissionsCRF CompletionTMF ManagementISF MaintenanceClinical Trial Management

Questions & Answers

Common questions about this position

What is the salary for this Senior CRA position?

This information is not specified in the job description.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What qualifications and skills are required for this role?

Candidates need at least 2 years of on-site monitoring experience, good knowledge of GCP and ICH guidelines, proficiency in Microsoft Word, Excel, PowerPoint, and strong written and verbal English communication skills. A High School Diploma or equivalent is required, with a degree in a scientific discipline or health care preferred.

What does the daily work involve for this Senior CRA role?

The role involves performing site monitoring visits, driving subject recruitment plans, administering protocol training, evaluating site practices for GCP compliance, managing study progress, and maintaining documentation like visit reports and TMF files.

What experience makes a strong candidate for this position?

Strong candidates will have at least 2 years of on-site monitoring experience, knowledge of GCP and ICH guidelines, and skills in communication, organization, problem-solving, and using Microsoft Office tools.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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