Job Overview :
Senior) Clinical Research Associate (s)CRA - sponsor-dedicated
Location : Home Office, Romania
A formula for clinical innovation : Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas.
In this role, you will work directly with one of our renowned key sponsors and advance the development of innovative, life-changing medications for oncological therapies.
What we have to offer : a strong international support network, flexible working solutions that facilitate a genuine work-life balance, excellent career opportunities, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.
If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, we are looking forward to meeting you!
As (Senior) Clinical Research Associate, you typically will :
Own all aspects of site management as described in the project plans
Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study
Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
Monitor data for missing or implausible entries
Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports
Review progress of projects and initiate appropriate actions to achieve target objectives
Interact with internal work groups to evaluate needs, resources and timelines
Act as contact for clinical trial suppliers and other vendors as assigned
Own the entire process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow ups on SAEs
Independently perform CRF reviews
Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems
Assist with training, mentoring and development of new employees, e.g. co-monitoring
Education / Qualifications :
Degree in a relevant field such as life sciences, biology, health care (management), nursing, pharmacology, (veterinarian) medicine, oecotrophology etc.
In lieu of the above, a completed equivalent vocational education (e.g. study nurse, research nurse, study coordinator.
and / or equivalent professional experience
Proven experience in clinical research in a variety of therapeutic areas including oncology
Solid independent monitoring experience in Romania as (Senior / Lead) CRA and familiarity with applicable local regulations and authorities
Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the Romanian regulatory authorities landscape
Working knowledge of Microsoft Word, Excel and PowerPoint
Effective time management and organizational skills and a keen attention to detail
Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
Excellent communication skills in both Romanian and English - spoken and written - are a must