Clinical Research Associate II

Worldwide Clinical Trials; United States; Remote; USD 70,000 - 120,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Clinical Research Associate to support site qualification, initiation, monitoring, and close-out visits across global studies. You will ensure data quality, safety reporting, and regulatory compliance while collaborating with sites and internal teams.

The role requires strong communication, planning, and problem-solving skills, plus a solid foundation in clinical research principles and regulatory guidelines.

Qualifications

• Excellent oral and written communication skills.
• Strong planning and organizational abilities.
• Demonstrated problem-solving and initiative.
• Ability to work in a structured, process-driven environment.
• Solid understanding of clinical research principles and regulatory requirements.

Responsibilities

• Responsible for site qualification, initiation, interim monitoring, site management and close-out visits per GCP and SOPs.
• Ensure data quality and timely reporting of safety events by site personnel.
• Perform feasibility studies for potential sites and coordinate regulatory submissions.
• Support study documentation: IRB/IEC approvals, informed consent, TMF updates.
• Coordinate shipment of study materials and maintain communication with sites.
• Provide training and input on protocol/designs and monitoring plans.
• Manage data queries and ensure site compliance with IP receipt and destruction.

Skills

Communication skills

Planning & organization

Interpersonal skills

Problem solving

Organized and methodical

Clinical research understanding

FDA/EU regulations knowledge

Microsoft Office

IxRS & EDC proficiency

Education

MD or PharmD or equivalent

Four-year science degree with clinical research experience

Nursing or life sciences degree with CRA experience

Tools

Microsoft Office

IxRS

EDC systems

Job 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.

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. 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.

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

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.