Syneos Health

Senior Clinical Research Associate - Single Sponsor in Austria, Sign-On Bonus up to 10k €

Location
Bratislava
Salary
-
Posted
23 Mar 2021
Closes
22 Apr 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Here at Syneos Health we are currently recruiting for a  Senior Clinical Research Associate in Austria to be home-based. This is an excellent permanent opportunity where one can develop their skill set further and work on exciting clinical studies for one sponsor. 

We have a nice gift for CRAs – join our  team and get 10k € sign-on bonus!

JOB SUMMARY

The Clinical Research Associate I (CRA ) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.  Performs all tasks routinely and independently.  May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a project or assessor of peers for sign-off visit purposes (as approved).

Your main responsibilities:  

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmaco-epidemiology Practice (GPP) and protocol compliance. 

Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.

May perform investigational product (IP) inventory, reconciliation and reviews storage and security.

Routinely reviews the Investigator Site File (ISF) for accuracy, timelines and completeness.

Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. 

Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. 

Participates in global clinical monitoring/project staff meetings/ bid defense meetings  (inclusive of Sponsor representation, as applicable).

Qualifications 

Bachelor’s degree or RN in a related field or equivalent combination of education

Min. 3 years of experience as a Clinical Research Associate 

Oncology experience required

RBM will be preferred

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

Must demonstrate good computer skills and be able to embrace new technologies

Excellent communication, presentation and interpersonal skills

Basic level of critical thinking skills expected

Fluency in German and English language