CRA / Clinical Research Associate

Key People

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Job ID :

15206


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc,Master of Science,phD


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

CRA; German, Early phase, phase I, phase 1, monitor


Salary :

€55 - €68 per hour


Date Posted :

15 Aug, 2019



Company Name :

Key People


Location1 :

Basel




Job Category :

Clinical Research Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

100.00%





Description

Job Responsibilities

* Contribute to the collection and the quality control of essential documents required for the Investigational Medicinal Product (IMP) shipment approval
* Participate in and contribute to the Clinical Pharmacology study team meetings by providing updates on monitoring activities
* Contribute to the CR0/Site selection process by sharing any experience with a CR0/Site (when required)
* Perform qualification visits (when required) and initiation visits as agreed with the Clinical Pharmacologist for the assigned studies
* Schedule and conduct routine monitoring visits and close-out visits at the frequency determined for the assigned studies, assuring that the CROs/Sites are delivering high quality research, overall integrity of study implementation, and adherence to the protocol at the clinical sites
* Ensure that the conduct of the assigned studies complies with ICH Guidelines, local regulations, and Standard Operating Procedures (SOPs)
* Identify CR0/Site issues, ensure resolution, and/or escalate issues if necessary
* Report to the Clinical Pharmacology study team and the CR0/Site staff any findings noted during monitoring visits by completing monitoring visit reports and follow-up letters as per Idorsia processes
* Manage the assigned CR0/Site(s) through regular contacts to ensure about:
o Site compliance with regulatory requirements and ethical standards throughout the study,
o Adequate enrolment, and
o Understanding of study requirements
* Operate as a central communication link between the Clinical Pharmacology study team and the CR0/Site staff from the time of the IRB/IEC approval to the close-out visit, for the assigned studies
* Manage all study supplies, including (but not limited to) IMP and laboratory supplies, from receipt to return or destruction, as appropriate
* Supervise biological samples shipment(s) from the CR0/Site to the bioanalytical laboratory or central laboratory (when appropriate)
* Ensure timely eCRF completion, if applicable, and proactively identify any data discrepancies by remotely reviewing the eCRF data
* Ensure that query resolution is completed in a timely manner and supervise database lock in collaboration with the Clinical Pharmacologist and the Data Scientist
* Responsible for Trial Master File (TMF) maintenance
* Ensure set-up and maintenance of the Investigator Site File
* Ensure about the transmittal of requested TMF documents under the CRA's responsibility (e.g., Delegation of Authority) to Idorsia
* Ensure completion of Clinical Trial Management System when applicable

Candidate's Requirements

* University degree in science or health-related discipline and/or degree in Nursing
* Minimum 1-2 years clinical research experience in a Contract Research Organization (CRC) or Pharmaceutical Company with experience in monitoring on-site clinical trials
* Strong knowledge of ICH-GCP guidelines and other applicable regulatory requirements
* Understanding of drug development process

Additional experience requirement of the Senior Clinical Research Associate
* Minimum 4-5 years clinical research experience in a CR0 or Pharmaceutical Company with experience in monitoring on-site clinical trials including 2+ years' experience in monitoring early phase clinical trials (i.e., phase 0, 1, 2a), phase 1 experience advantageous



Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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