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Contractor CRA in Germany - Diabetes, Alzheimer's Disease, Oncology

Employer
Worldwide Clinical Trials
Location
Berlin, DE
Salary
Competitive
Start date
20 Nov 2020
Closing date
20 Dec 2020

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Discipline
Clinical Research, Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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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
  • Provide input into the design of protocols, CRFs and monitoring plans as requested
  • 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
  • Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate
  • Complete final site close out visit and report

OTHER SKILLS AND ABILITIES:
  • Excellent oral and written communication skills
  • Good planning and organizational skills with effective time management
  • Excellent interpersonal skills
  • Demonstrate initiative and problem solving skills
  • Ability to work in an organized and methodical manner
  • Thorough understanding of clinical research principles and process
  • Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
  • Basic knowledge of three to five therapeutic area, sufficient to function as a CRA or have an in-depth knowledge of two to three therapeutic areas
  • Thorough understanding of standard operating procedures
  • Proficiency in Microsoft Office
  • Proficiency with IxRS, EDC systems

REQUIREMENTS:
  • Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, Phd, or equivalent Pharmacy degree, etc. ) and with a minimum experience of one year as a Clinical Research Associate Level I OR
  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science and a minimum experience of two years in clinical research (e.g. study coordinator, CTA, CRA I, etc.), OR
  • Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree preferred) and two years as a Clinical Research Associate Level I
  • 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


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Company

Find out more about working for our company

Worldwide Clinical Trials -hub-button

Brief Company Description; 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

 

Company info
Website
Mini-site
Worldwide Clinical Trials
Telephone
+44 115 956 7711
Location
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom
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