Senior Clinical Research Associate at IQVIA Nigeria

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

We are recruiting to fill the position below:

Job Title: Senior Clinical Research Associate

Job ID: R1482978
Location: Lagos
Job type: Full-time

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 Harmonisation (ICH) guidelines.
• Work with sites to adapt, drive, and track the 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 the 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 Investigational's Site File (ISF) is maintained in accordance with GCP / ICH 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.
• Act as a mentor for clinical staff, including conducting co-monitoring and training visits.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting the development of the project subject recruitment plan on a per-site basis.
• If applicable, may be accountable for site financial management according to an executed clinical trial agreement and retrieve invoices according to local requirements.

Qualifications

• Candidates should possess a Bachelor's Degree in a scientific discipline or health care preferred
• Requires at least 4 years of year of on-site monitoring experience.
• An equivalent combination of education, training and experience may be accepted in lieu of a degree.
• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in the 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 a good command of the English language.
• Organisational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Application Closing Date
Not Specified.

How to Apply
Interested and qualified candidates should:
Click here to apply online

Note: Candidate must be located in country to be considered for this role.