Senior Clinical Research Associate

Clinical Research Associate

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 3,500+ 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.

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

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.

Tasks may include but are not limited to:

• Perform feasibility studies for potential sites as requested
• Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
• Function in the role of Lead CRA for global studies, coordinating CRAs
• Develop Clinical Monitoring Plan 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 to 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, 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 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.

Other skills and abilities:

• Excellent oral and written communication skills
• Excellent planning and organizational skills with effective time management
• Excellent interpersonal skills
• Demonstrate 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

Requirements:

• Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc.) and with a minimum experience of three years as a Clinical Research Associate
• 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 five years as a Clinical Research Associate
• Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree preferred) and a minimum seven years as a Clinical Research Associate
• 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

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.