Senior Clinical Research Associate – CNS, Immunology

This is a fully remote position, open to applicants in Germany.

📋 Description

• Oversee site qualification, initiation, interim monitoring, management, and close-out activities in alignment with study protocols, GCP, applicable regulations, and SOPs.

• Evaluate informed consent, source documentation, CRFs, safety information, and protocol adherence to ensure patient safety and data integrity.

• Address data queries with investigative sites.

• Maintain regulatory and site-related documentation.

• Manage accountability for investigational products.

• Support the timely and accurate collection of study data.

• Coordinate site regulatory and ethics documentation, study materials, and Trial Master File documentation.

• Act as a Lead CRA on global studies as needed.

• Coordinate CRAs and assist in the development of monitoring plans, study-specific tools, templates, and review of visit reports.

• Guide less experienced CRAs and site staff through mentorship, training, accompanied visits, and constructive feedback.

• Collaborate with Project Management and study teams to assess deliverables and milestones.

• Engage in investigator meetings and bid defenses.

• Provide monitoring and site-management expertise in protocol and CRF design, process initiatives, and training for the study team.

⛳️ Requirements

• MD or Pharmacy qualification with a minimum of 3 years of CRA experience; or a four-year college degree in a medical, biological, physical, health, pharmacy, or related science with at least 5 years of CRA experience; or a two-year college qualification or equivalent education/training, preferably in nursing or life sciences, with at least 7 years of CRA experience.

• Extensive knowledge of clinical research principles and processes.

• In-depth understanding of FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, and relevant SOPs.

• Strong knowledge in two to three therapeutic areas.

• Excellent skills in communication, interpersonal relations, planning, organization, time management, initiative, leadership, and problem-solving.

• Proficiency with Microsoft Office, IxRS, and EDC systems.

• Valid current passport and driving license, with a willingness to travel.

• Fluency in the local language(s) of the countries under responsibility.

• Proficient in spoken and written English.

• Candidates must reside within Germany to facilitate site visits and study activities.

• Approximately 6-8 days of travel to investigative sites each month.

🏝️ Benefits

• Collaborative and inclusive work environment.

• Opportunities for growth and learning.

• Home-based/remote work arrangement.

• Chance to support global studies as a Lead CRA.

• Mentoring and training opportunities.

• Opportunity to contribute to monitoring plans, study tools, templates, and training.

• Involvement in investigator meetings and bid defenses.