Language Area Coordinator (Monitor)

The company is a non-profit research network committed to advancing research, facilitating the conduct of clinical trials, and improving clinical care in Huntington's Disease. Through them a platform has been created such that basic scientists, clinicians, patients, and families can collaborate on academic and industry studies to fulfil its mission. 

The network has a structure of regionally based staff who are referred to as Language Area Coordinators (LAC) because they speak the local language of their region and have the capabilities to support their local clinical sites and interact with the local researchers and patient associations. They are also responsible for the on-site monitoring of the study data.

Monitoring experience is not essential for this role. It would suit someone coming from a Study/Research/Trial Coordinator background looking to start their career in monitoring. This is a rolling fixed-term contract where you would be responsible for your own tax.

Main Function of Post:

Primary responsibilities are to undertake on-site data monitoring of the company's core study, within the local language area and, if necessary, to provide support to other areas/countries as language capabilities permit. Future duties could also involve assisting with other endorsed projects, site management activities for clinical trials, and other research projects as defined by the Scientific Strategic plan or required by the research platform.

Details of the role:

• To be familiar with the background and structure of the company and its core study.

• To undertake regular on-site monitoring of the project, in line with the International Conference on Harmonisation (ICH) good clinical practice (GCP) and standard operation procedures, including verification of source documentation. This will involve visiting country/area study sites on a regular basis and submitting written visit reports.

• To facilitate and coordinate study administration within Language Area Coordination (LAC): to ensure project documents such as approvals, applications and consent forms are appropriately completed, filed, and documented.

• To assist with obtaining relevant Ethics Committee and Institutional approvals for the study.

• To facilitate implementation of study sub-contracts.

• To assist with study site management: communicate study information to sites and respond to queries from personnel based at each study site and provide general study support to the site staff.

• To initiate/ train new and existing study sites staffs according to the study protocol and procedures: to train study sites on database (entry and export), assessments (training and certification), consent, biosamples...

• To generate regular LAC Reports: monthly, quarterly, annual.

• To ensure that an understanding of the importance of confidentiality is applied when undertaking all duties.

• To attend LAC face-to-face meetings and regular telephone conferences.

• To support EHDN Working Group activities where required.

• To organise and facilitate a Site Investigator’s Meeting if requested.

• To maintain regular contact with lay associations (e.g. with the national Huntington’s DiseaseAssociation) as requested.

• To be willing to travel regularly, nationally, and sometimes within Europe.

• To occasionally perform other duties which are not included above, but which will be consistent with the role.

• To be able to work home based.

• Essential Criteria

• ❖ Educated to degree level in an appropriate field
  ❖ Previous experience of clinical research
  ❖ Awareness of ICH GCP Guideline and local regulation for clinical trials
  ❖ Excellent inter-personal skills with an ability to work co-operatively in a multidisciplinary setting, in particular liaison with a wide range of people including other study sites, professional bodies, lay associations etc.
  ❖ Excellent PC skills (Excel, Word, Email, Internet, PowerPoint)
  ❖ Meticulous and accurate in all aspects of work
  ❖ Able to communicate effectively orally and in writing in local language and in English
  ❖ Able to work under pressure and meet deadlines
  ❖ Resourceful and able to act on own initiative
  ❖ Willing to travel within Europe
  ❖ A very high level of consideration and care for patients and research subjects
  ❖ Interested in research and a commitment to quality in the research process