Job title: Senior Clinical Research Associate

Responsibilities:

1. to provide monitoring services for studies in accordance with ICH-GCP, local laws, and Company procedures

1. to effectively plan and manage the study or project by forecasting & managing timelines, budgets, materials & resources

1. to work effectively and efficiently to ensure delivery of clinical studies to meet agreed standards, so that strategic global clinical & local marketing company needs are met

1. to review on a monthly basis with the Clinical Research Team Leader, current status of all studies.

1. to participate in the training and development of other team members through sharing of knowledge & coaching in clients procedures & the local clinical research environment

1. to maintain & develop a knowledge base of local investigators & key opinion leaders providing the optimal selection of investigators in studies

1. to initiate and co-ordinate the provision of services from internal and external partners (e.g. global project teams, central laboratories, clinical research organisations, investigational product sections etc)

1. to review all clinical study documents and when appropriate recommend changes in accordance with clients operating procedure and local requirements

1. to assist in activities associated with audits and regulatory inspections

1. to communicate with clients colleagues in Ireland to share therapeutic / product knowledge, experience and key local information of value to the Irish business

1. All activities are to be conducted in an ethical, responsible and lawful manner as set out in the Clients Group Policies & Standards and complying with the specific details of the Pharma Code & the IPHA Code of Marketing Practice.

Required attributes:

Highly motivated individual, who is well-organised, able to work alone or as part of a small team.

Flexible with the ability to prioritise and manage multiple tasks while working to tight deadlines.

Requirements:

• 2 – 3yr experience as Clinical Research Associate

• University degree or equivalent experience

• Good communication and presentation skills

• Competent with Microsoft Word, Powerpoint and Excel

• Ability to cover the responsibilities of a Clinical Study Administrator