Clinical Research Associate (CRA

EPM Scientific

London

Hybrid

GBP 30,000 - 40,000

Full time

14 days+

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Benefits offered by this job

Competitive salary

Benefits package

Opportunity for growth

Job summary

A leading recruitment firm is seeking a Junior Clinical Research Associate in West London. This role involves site evaluation, data monitoring, and regulatory submissions. Candidates should possess a degree in Biological Sciences and have at least 2 years of experience as a CRA. Competitive salary and a hybrid work model are offered to contribute to healthcare improvement.

Qualifications

At least 2 years proven experience as a CRA.
Working knowledge of ICH GCP guidelines.
On-site experience is essential.

Responsibilities

Conduct site evaluations and setup for studies.
Monitor data collection and safety reporting.
Ensure compliance with regulatory requirements.

Skills

Site management

Data monitoring

Regulatory submissions

Communication

Education

Graduate qualifications in Biological Sciences

Post-graduate qualifications desirable

Tools

Clinical trial management software

ICH GCP guidelines

Job description

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Direct message the job poster from EPM Scientific

Consultant at EPM Scientific | Permanent Solutions

We're currently partnering with a leading international pharmaceutical company to recruit a Junior CRA.

Location: West London
Hybrid: Twice a week in office

DESCRIPTION OF THE ROLE

* Site evaluation and setup for commercial distribution including training of dosing in collaboration with the Clinical Project Manager or designee
* Maintenance of contacts with sites for commercial distribution and sites which may be involved in clinical trials
* Collection of essential documents according to ICH-GCP E6 (R2) and applicable regulations
* Monitoring of data collection and pharmacovigilance/ safety reporting at the sites where a post authorisation study is conducted
* Site setup, initiation, close-out and management (including monitoring) of sites participating in clinical and post-authorisation studies on an as needs basis
* Site management including site supplies, site payment process, etc.
* Study/clinical trial status tracking and progress update to team
* EC/IRB and regulatory submissions
* Participation in investigator meetings and other meetings as necessary
* Attendance of conferences as applicable
* Contribution to other tasks such as creation of newsletters as directed by the Clinical Project Manager or designee
* Assist with audits as required
* Contribute to initiatives and process improvements as required
* Contribute to Literature Reviews.

KEY RESULT AREAS

* Feasibility assessments/visit evaluations for clinical and post-authorisation studies
* Site setup for commercial distribution according to post-authorisation requirements
* Site setup for clinical trials (as needs basis)
* Site management: investigating, following up and escalating site issues as needed.
* Delivery of data accuracy through CRF review through on-site and remote monitoring according to the risk-based monitoring plan to ensure patient safety, compliance and decreased risks.
* Assistance with pharmacovigilance, safety reporting management and investigations of quality complaints
* In-house/ on-site document quality management (including, but not limited to, trial master file, investigator site file).

QUALIFICATIONS/EXPERIENCE

* Graduate qualifications in Biological Sciences, Nursing, Pharmacy or related discipline
* Post-graduate qualifications desirable
* At least 2 years proven experience as a CRA
* Working knowledge of ICH GCP guidelines
* On-site experience
* Proven experience in managing clinical trials/projects

WHAT'S ON OFFER

* A competitive salary with benefits.
* The chance to contribute and be part of team whose work directly benefits healthcare and strives to improve people's lives.
* A real hands-on opportunity to gain a high degree of commercial exposure.
* The chance to work alongside world-leading scientific experts.
* Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery.

Interested in making a difference?
Apply now or reach out to learn more about this exciting opportunity!

Seniority level

Seniority level
Entry level

Employment type

Employment type
Full-time

Job function

Job function
Health Care Provider
Industries
Medical Practices

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