Clinical Research Associate 1

2 weeks ago

Singapore IQVIA Full time

As our business grows, we are looking to further strengthen our Clinical Operations team in **IQVIA Pakistan**. We have a number of great opportunities for **Clinical Research Associate** and **Senior Clinical Research Associate** in **Karachi**, **Lahore**, and **Islamabad**.

You will 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.

**Key Responsibilities**:

- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- 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 site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

**Key Requirements**:

- Bachelor's Degree in scientific discipline or healthcare.
- CRA 1: Some years of on-site monitoring experience.
- CRA 2: Adequate years of experience of on-site monitoring experience.
- Senior CRA: Significant years of experience of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time management skills.

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