Sr. Clinical Research Associate (Germany)

7 hours, 40 minutes ago
Full-time
Senior
Project and Program Management
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986

Description

  • Independently conduct and document site qualification, initiation, monitoring, and close-out visits onsite and remotely.
  • Review source documents, study systems, ISF, and TMF records for accuracy, completeness, and compliance.
  • Resolve or escalate data queries, protocol deviations, action items, and other site issues.
  • Serve as the primary liaison for investigative sites and coordinate study communications, training, and system access.
  • Coordinate shipment and delivery of investigational products, laboratory supplies, ePROs, and study documents.
  • Support site selection, activation, recruitment, timelines, milestones, and start-up activities.
  • Participate in investigator meetings, study progress meetings, audits, and inspections as required.
  • Mentor CRA I and II staff, perform assessment or co-monitoring visits, and provide feedback.
  • Contribute to process improvement initiatives, best practices, and CRA candidate interviews.

Requirements

  • 4–6 years of related clinical research experience required; 7–9 years preferred.
  • Honors bachelor’s degree required; master’s degree preferred, or equivalent education and experience.
  • Fluent written and verbal English.
  • Health Sciences, Life Sciences, Pharmacy, or Nursing degree preferred; Sr. CRA or ACRP certification/designation is an asset.
  • Experience with Phase I–IV clinical trials preferred.
  • Thorough knowledge of ICH-GCP and local regulatory requirements.
  • Proficiency with EDC systems such as Medidata Rave or Oracle InForm, IRT, eTMF, CTMS, and Microsoft Office.
  • Strong interpersonal, communication, organizational, problem-solving, and independent-working skills.
  • Ability to travel 40–60% depending on assignment and site location.
  • Valid driver’s license required.

Benefits

  • Home-based work environment.
  • Regular travel associated with clinical site monitoring.

Interested in this position?

Apply directly on the company website

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