Associate CRA

IQVIA; England; On-site; GBP 25,000 - 35,000; Full time

Job summary

A leading healthcare research organization in the United Kingdom is seeking a Clinical Monitor to conduct clinical monitoring visits and ensure compliance with study protocols and regulatory requirements. The ideal candidate holds a Bachelor's or Master's degree in a scientific discipline, possesses strong communication and computer skills, and has a good command of the English language. This position offers an opportunity to develop your career while contributing to impactful research.

Qualifications

• Bachelor's or Master's Degree in a scientific discipline or health care preferred.
• Good knowledge of clinical research regulatory requirements.
• Experience within CRO, hospital or nursing setting preferred.

Responsibilities

• Conduct clinical monitoring visits in accordance with study protocol.
• Administer protocol and study training to assigned sites.
• Manage the progress of assigned studies and ensure proper documentation.

Skills

Good knowledge of clinical research regulatory requirements

Communication skills

Computer skills

Ability to establish effective working relationships

Education

Bachelor's or Master's Degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

Job description

Engage in a structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

Essential Functions

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
• Gain experience in study procedures by working with experienced clinical staff.
• Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
• Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Under close supervision, 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.
• Under close supervision, 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 Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements.
• Under close supervision may support start-up phase.
• Under close supervision, 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, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress.

Qualifications

• Bachelor's or Master's Degree in scientific discipline or health care preferred.
• 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).
• Experience within CRO, hospital or nursing setting preferred.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English language.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Right to work in the United Kingdom required, this role is not eligible for UK visa sponsorship.

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