Job Details:
My client is one of the world''s leading global CROs with an excellent reputation in the market. Here, you can expect less travel and a lower protocol load in comparison to other global CROs. Your hard work will be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas and the chance to advance your career in clinical research.
They''re now looking for a Start-up Specialist / Initiation Clinical Research Associate, that will specialise in performing all study start up activities for clinical trials.
Start-up Specialist:
GERMANY - HOME BASED
Your tasks include but are not limited to:
- Start-Up (from site identification through pre-initiation)
- Act as a direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements, Clinical Site Agreements and any amendments.
- Conduct remote Qualification Visits.
- Prepare and submit IRB/IEC and MoH/RA applications, resolving conflicts, determining appropriate follow up until final approval.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecast, develop, manage, and revise plans and strategies for:
- IRB/IEC and MoH / RA submission/approval,
- Site activation
- Patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
Your profile:
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
- Previous experience in study set up / site initiation / study start up experience or equivalent experience in clinical research environment
- Good previous Clinical Site Agreement (CSA) and site contracts experience is desirable
- Fluent German and English skills
If this sounds like a good match for your profile, apply now here or by sending me an e-mail, or get in touch via phone call for a confidential consultation:
Email: T.Chalkidou(at)nonstop-recruitment.com
Phone: +49 892 109 3363
Internal Extension: 3514