Clinical Research Associate II

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.

*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:*

_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
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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

*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

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.

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do.  Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers , or connect with us on LinkedIn .