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
US$90000 - US$130400 per annum
San Francisco, USA
Proclinical are currently recruiting for an In Vivi (Senior) Research Associate for a temporary contract position based in San Francisco Bay Area, United States.
Highly Competitive
Paris, France
Proclinical Staffing est en partenariat avec une CRO d'envergure globale recherchant en ce moment des Attachés de Recherche Clinique Séniors.
Highly Competitive
Frankfurt, Germany
Proclinical is currently recruiting for an experienced CRA II or SCRA for a permanent, fully remote position based within Germany.