Senior Clinical Research Associate (CRA III) will be responsible for performing and coordinating all aspects of clinical monitoring and site management, ensuring that country and site targets are achieved, in compliance with ICH/GCP, SOPs and all other applicable regulatory requirements.

Key Responsibilities:

Oversee all aspects of study site management including; collation of trial related documentation (site contracts, consent documents, letters of agreement, confidentiality agreements), tracking or site performance, status reports to ensure high quality data resulting in consistently low query levels in good Quality Assurance reports.

Assists with execution of site contracts.

Involved in recruitment of potential Investigators, preparation of Ethics Committee/Independent Regulatory Board (EC/IRB) submissions, renewals, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks.

Conduct pre study visits and site initiation meetings; training investigators and other trial staff in the protocol, data collection methods, completeness and conforms to protocol requirements, in accordance with local regulations, ICH-GCP and SOPs.

Track patient recruitment and report on site issues/strategies to increase patient accrual into the trial (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to GPs).

First point of contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing studies.

Oversee tracking of completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.

Ensure maintenance of project site files including:

ethics committee approvals and reports,

curricula vitae of investigators and study personnel,

training/delegation log

clinical documentation is current

lab reference ranges are current

investigator and site correspondence log

schedules of payment.

Conducts remote monitoring and site visits - assessing protocol and regulatory compliance, and reporting conduct using applicable documentation.

Ensure site staff are trained in protocol specific procedures and are ICH-GCP compliant.Comply with all applicable laws / regulations of each country in which we do business.

Demonstrate high ethical behaviour at all times, whether dealing with colleagues, vendors, patients, or physicians.

Report, write narratives and follow-up on legal, compliance and ethical violations in a timely manner.

Review progress of projects and initiate appropriate actions to achieve target objectives

Input to creation of monitoring plans

Organise and make presentations at Investigator Meetings

Provides support and confer best practice to more junior colleagues and CRAs as necessary.

Create and deliver company specific training and contribute to process development.

Desired Skills and Experience:

Proven leadership/supervisory experience

Life science or other relevant degree

Excellent organisational skills

Excellent interpersonal skills

Good problem solving abilities

3-4 years CRA experience which must include pre-study, initiation, routine monitoring and close-out visits)

Experience of working in observational trials

Proven ability to develop and update working practices

Flexible and effective communication and negotiation skills

Ideally a strong understanding of cardio vascular disease and treatment

Ability to monitor sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

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