CRA in Germany

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Discipline
Clinical Research
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Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details
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Job Details

SUMMARY: Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

RESPONSIBILITIES:

• Perform feasibility studies for potential sites as requested
• Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
• Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
• Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
• Document site visit findings via written reports
• Assess, monitor, and train study site staff on protocol adherence as required
• Review study subject safety information and informed consent
• Conduct source document verification for compliance, patient safety, and veracity of data
• Review CRFs using paper or electronic data capture systems
• Assist the site in maintenance of the Investigator Site File
• Maintain regular communication with sites
• Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
• Assist sites in data query resolution
• Ensure site compliance with IP receipt, accountability and return or destruction
• Complete final site close out visit and report

OTHER SKILLS AND ABILITIES:

• Good oral and written communication skills
• Good planning and organizational skills with effective time management
• Good interpersonal skills
• Ability to work in an organized and methodical manner
• Basic understanding of clinical research principles and process
• Basic understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
• Basic knowledge of one therapeutic area, sufficient to function as a CRA
• Good understanding of standard operating procedures
• Basic knowledge of Microsoft Office
• Familiarity with IxRS, EDC systems

REQUIREMENTS:

• Medical Doctor (MD) degree OR
• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
• Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and one year experience with clinical research (e.g. study coordinator, CTA, etc.)
• Willingness to travel required
• Valid current passport required
• Driving license required
• Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English

LI-KP1

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