[Hiring] Clinical Research Associate II @Worldwide Clinical Trials

Role Description

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
• Perform other duties as assigned.

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 areas, 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

Company Description

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.