Similar posts
Senior CRA (Clinical Research Associate) Major Pharma - Romania
- Permanent
- Clinical Research Associate (CRA)
- Romania
This vacancy has now expired. Please see similar roles below...
Proclinical are recruiting for a Senior CRA (Clinical Research Associate) Major Pharma to join a CRO. This role is on a permanent basis with the ability to work remotely from anywhere in Romania.
Responsibilities:
- Accountable for assisting with various studies concurrently.
- Support in preparing project specific materials such as status reports, newsletters, templates, study manuals/binders, etc.
- Conduct quarterly QC of allocated studies/sites in the eTMF rendering to the company's oncology SOPs.
- Keep updated on site information, this involves all contact details and distribution lists for reports and clinical supplies.
- Work alongside other members of the project team to meet sponsor, protocol and company goals of regulatory promptness which involves contract and budget deliberations when needed.
- Offer assistance to project management through ongoing project reports and updates.
- Form and uphold efficient, regular communications with study sites, offering study updated and assistance to sites in a timely manner.
- Recognise and raise data quality concerns to guarantee clinical data integrity.
- Conduct ongoing management of necessary regulatory documentation at the outset as well as across the lifespan of a study.
- Contribute to the performance of pre-qualification, initiation, regular monitoring, remote monitoring, and close-out visits rendering to pertinent SOPs.
- Other duties to be assigned.
Key Skills and Requirements:
- Educated to a degree level in a biological or human-connected field or corresponding work experience.
- Demonstrable experience in a clinical research associate role with a background in managing clinical trial sites.
- Familiarity with supervising oncology early phase studies.
- Know-how of ICH regulations and GCP which involves comprehension of regulatory needs.
- Expertise on the drug development process and the company's organisational structure.
- Exhibits a professional attitude with good customer orientation.
- Interpersonal and communication skills both verbally and in writing.
- Works well both independently as well as in a team.
- Able to multitask and manage time efficiently.
- An organised individual with computer literacy.
- Competent working remotely as well as absorbing and implementing expertise gained through both internal and external trainings on protocols allocated.
- Willing to travel for business needs.
- Fluency English as well as 2 other languages being either French, Spanish, Dutch or German.
If you are having difficulty in applying or if you have any questions, please contact Jack Wingrove at +44 203 831 7675.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-JW1
#Clinical
Related jobs
Highly Competitive
South San Francisco, USA
Proclinical is working alongside a pharmaceutical company to recruit for a Sr Research Associate to focus on Hybridoma. This is a temporary contract position based in South San Francisco, California.
Highly Competitive
Stevenage, England
Proclinical is working alongside a biotechnology company to recruit for a Research Assistant. This is a permanent position based in Stevenage, Hertfordshire.
€75000 - €80000 per annum
Munich, Germany
Proclinical is working alongside a Contract Research Organisation to recruit for a SCRA - Sponsor Dedicated. This is a permanent, fully remote position from within Germany.
Highly Competitive
München (81249), Germany
Proclinical is actively seeking a dedicated Senior Clinical Research Associate to join a well established CRO. This is a remote role in Germany.
Highly Competitive
München (81249), Germany
Exciting Opportunity! Proclinical is partnering with a CRO to find a dynamic Senior Clinical Research Associate.