Company: Docs Global (Continental Europe)
Location: Any city in Germany,Germany
Reference: Ref AS-018949
Closing Date: 08 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Clinical Research Associate / Clinical Monitor (m/f) (Any location in Germany) Position type : Permanent contract / full time / Home Office Ref. Number : AS-018949 Job Summary: DOCS has partnered with a highly prestigious organization with one of the most robust pipelines within the industry. This is a great chance for experienced candidates to become part of this company and participate in its ongoing successes in the future.
Roles & Responsibilities of the position
Roles & Responsibilities of the position:
The Clinical Research Associate will be responsible for monitoring local clinical studies, primary contact point between the sponsor and the investigational sites.
A successful candidate is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.
• Participates in site feasibility and/or pre-trial site assessment visits.
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
• Ensures site staff are trained, site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct and clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
• Ensures accuracy, validity and completeness of data collected at trial sites.
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
• Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities.
• Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff.
• University degree in Life Sciences, Nursing, or relevant clinical research experience is required. Minimum 1 year of clinical monitoring experience.
• Experience in oncology and CNS is strongly preferred.
• Solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
• Solid communication and computer skills required.
• Proficient in speaking and writing German and English.
• Willingness to travel with occasional/regular overnight stay away from home depending on the region.
• Flexible mindset and ability to work at a fast pace within small exploratory study teams.
Remuneration & other details
Base salary based on experience level. Company Car or Car Allowance. Pension. Overtime compensation. BahnCard. Mostly local travelling depending on location. Home Office equipment.
Interested? Please submit your CV to firstname.lastname@example.org or call +49 (0)89 244 407 113. We are looking forward to getting to know you.
DOCS has grown to become the premier resourcing provider of global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997 we are driven by our core values that guide our culture and support our goal to become Trusted Partner. Our five core values are: Our people, Excellence, Accountability, Integrity and Openness.
CRO, Sponsor, Pharmaceutical, Biotechnology, Biotech, Clinical Research, Permanent, Monitoring, CRA, Site Manager.
2 Globeside, Globeside Business Park
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