Clinical Research Associate

Accountabilities:

• • Monitor clinical investigative sites to ensure successful protocol execution, data quality, participant safety, and compliance with applicable requirements.
  • Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase I to III clinical studies.
  • Ensure clinical sites adhere to Good Clinical Practice (GCP), ICH guidelines, applicable regulations, monitoring plans, SOPs, and quality standards.
  • Proactively identify site issues, develop and communicate corrective actions, and follow through on action plans to maintain compliance and study timelines.
  • Oversee site personnel activities without direct authority, building effective relationships and influencing teams to achieve study objectives.
  • Maintain regulatory inspection readiness at assigned clinical sites and ensure required documentation remains complete and accurate.
  • Review the quality and timeliness of data submitted by study sites, including appropriate safety-event reporting and follow-up.
  • Support the safety and protection of study participants by ensuring adherence to monitoring plans, protocols, regulatory requirements, and quality procedures.
  • Train investigators and site personnel on study protocols and relevant regulatory requirements in collaboration with project team members.
  • Manage investigator payments in accordance with contractual obligations and support negotiation of investigator and hospital agreements with relevant stakeholders.
  • Identify, assess, and recommend potential investigators and clinical sites to support future study placement.
  • Maintain accurate expense reports and complete required administrative activities in accordance with applicable guidelines.
  • Collaborate with internal and external stakeholders to anticipate and resolve clinical site challenges and support successful study delivery.

  Requirements:

  • Appropriate tertiary qualification in a health-related discipline such as medicine, science, nursing, or a comparable field.
  • Minimum of 2 years of clinically related monitoring experience, including on-site monitoring of investigational drug or medical device trials.
  • Strong knowledge of clinical research practices and relevant therapeutic indications.
  • In-depth understanding of regulations governing clinical research, including ICH/GCP guidelines and applicable local requirements.
  • Familiarity with key aspects of clinical study monitoring, including data review, drug accountability, documentation, and site management.
  • Strong planning, organizational, and time-management skills, with the ability to manage multiple projects, priorities, and deadlines in a dynamic environment.
  • Strong analytical, conceptual, and problem-solving capabilities, with sound judgment when addressing study-related issues.
  • Excellent interpersonal and communication skills, with the ability to communicate clearly and influence site personnel and stakeholders.
  • Demonstrated integrity, business ethics, accountability, and commitment to quality.
  • Comfortable working independently while collaborating effectively with cross-functional teams.
  • Proficiency with Microsoft Office tools, including Outlook, PowerPoint, Excel, and Word.
  • Strong technology skills and confidence using multiple systems and digital tools in daily clinical operations.
  • Willingness and ability to travel at least 50% of the time.
  • Valid driver’s license and passport.

  Benefits:

  • Innovative and collaborative work environment focused on meaningful clinical research.
  • Professional development and career growth opportunities.
  • Paid time off, including vacation, holidays, personal days, and volunteer days.
  • Employee stock purchase opportunities.
  • Wellness spending account.
  • Flexible health insurance options.
  • Retirement savings programs.
  • Bonus plan.
  • Opportunity to contribute to research that supports the development of innovative treatments and solutions for serious health conditions.
  • Broad exposure to clinical research operations across multiple study phases and clinical sites.