Job: Senior Clinical Research Associate (Ghana, Nigeria, Senegal or Ivory Coast) at IQVIA
IQVIA is looking for various senior clinical research associates in Ghana, Senegal, Nigeria and Ivory Coast to work on new female circumcision opportunities.
Perform site monitoring and management work to ensure sites are conducting the study(s) and reporting study data in accordance with the study protocol, applicable regulations and guidelines, and sponsor requirements.
- Conduct site monitoring visits (screening, initiation, monitoring and closing visits) in accordance with the scope of contracted work and good clinical practice.
- Work with sites to adapt, pilot and track subject recruitment plan based on project needs to improve 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 compliance with applicable regulations. Escalate quality issues, if any.
- 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. Can support the start-up phase.
- Ensure that copies/originals (if applicable) of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator Site File (ISF) is maintained in accordance with PCBs and local regulatory requirements.
- Create and maintain proper documentation regarding site management, monitoring of visit results and action plans by submitting regular visit reports, generating follow-up letters and other required study documents.
- Collaborate and liaise with study team members for project execution support as required.
- If applicable, may be responsible for supporting the development of the project subject recruitment plan on a per-site basis.
- If applicable, may be responsible for the financial management of the site in accordance with the signed clinical trial agreement and collect invoices in accordance with local requirements.
- Bachelor’s degree in a science discipline or health care field preferred. Request
- Requires at least 2 years of on-site monitoring experience.
- An equivalent combination of education, training and experience may be accepted in lieu of the degree.
- Good knowledge and ability to apply applicable regulatory requirements in clinical research.
- i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided for in company training.
- Computer skills, including proficiency in Microsoft Word, Excel and PowerPoint and use of laptop and iPhone and iPad (if applicable).
- Written and verbal communication skills, including a good command of the English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with colleagues, managers and clients.
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