This senior role is responsible for managing clinical trial sites, ensuring data quality, and overseeing the timely submission of study data and safety reports. It suits an experienced Clinical Research Associate who can lead and mentor others while adhering to Good Clinical Practices and regulatory requirements.
Responsibilities
Perform feasibility studies for potential sites as requested
Conduct pre-study, study initiation, and interim monitoring visits in adherence to protocol requirements
Function as Lead CRA for global studies, coordinating CRAs
Develop Clinical Monitoring Plans as requested
Conduct site visit trip report review and provide feedback and edits
Provide mentoring and guidance to less experienced CRAs and site staff when needed
Design study-specific tools and templates as requested
Actively participate in study team and investigator meetings
Actively participate in bid defenses
Create and conduct training for study team members or colleagues as requested and appropriate
Work with Project Management to evaluate deliverables and study milestones
Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g., IRB / IEC study approval, informed consent)
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 and CRFs 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 and assist sites with data query resolution
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)
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
Perform other duties as assigned
Requirements
Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, PhD, or equivalent Pharmacy degree) with a minimum of three years of experience as a Clinical Research Associate
OR a minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science and a minimum of five years of experience as a Clinical Research Associate
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OR a two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree preferred) and a minimum of seven years of experience as a Clinical Research Associate
Willingness to travel
Valid current passport
Driving license
Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English
Excellent oral and written communication skills
Excellent planning and organizational skills with effective time management
Excellent interpersonal skills
Demonstrated initiative and problem-solving skills
Ability to lead and motivate assigned team (if applicable)
Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
Extensive understanding of clinical research principles and process
Thorough understanding of FDA and/or EU Directives and regulations, ICH Guidelines, and local regulatory requirements
Thorough understanding of two to three therapeutic areas sufficient to function as a Lead CRA as appropriate
Thorough understanding of standard operating procedures
Proficiency in Microsoft Office
Proficiency with IxRS, EDC systems
Benefits
Commitment to enabling professionals from all backgrounds and experiences to succeed
Cultivating a diverse and inclusive environment that promotes collaboration and creativity
About the Company
Worldwide Clinical Trials is a global, midsize CRO with over 3,500 experts. The company's mission is to improve lives by working with passion and purpose every day.
