Senior Clinical Research Associate – CVM/IMID

This is a fully remote position, open to applicants in Australia.

📋 Description

• Conduct feasibility assessments for potential study sites.

• Carry out pre-study activities, study initiation, interim monitoring, site management, and study closure visits.

• Serve as the Lead CRA for global studies and oversee the coordination of CRAs.

• Create Clinical Monitoring Plans.

• Review site visit reports and offer constructive feedback.

• Mentor and support less experienced CRAs and site personnel.

• Design tools and templates tailored for specific studies.

• Take part in study team, investigator, and bid defense meetings.

• Develop and deliver training sessions for study team members or colleagues.

• Collaborate with Project Management to assess deliverables and study milestones.

• Compile documentation for regulatory and ethical submissions.

• Coordinate the shipment and receipt of study-related materials.

• Document findings from site visits in written reports.

• Contribute to the development of protocols and Case Report Forms (CRFs).

• Evaluate, monitor, and instruct site staff on protocol compliance.

• Review safety information of subjects and informed consent documents.

• Conduct verification of source documents.

• Review CRFs in both paper and electronic data capture systems and assist with resolving data queries.

• Aid sites in maintaining the Investigator Site File.

• Maintain consistent communication with study sites.

• Update site-related documentation for filing in the Trial Master File.

• Ensure compliance of sites with investigational product receipt, accountability, and return or destruction requirements.

• Carry out accompanied site visits for CRA evaluation or training.

• Complete final site closure visits and reports.

• Perform additional duties as assigned.

⛳️ Requirements

• Medical Doctor (MD) or Pharmacist degree (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc.) with at least three years of experience as a Clinical Research Associate.

• OR completion of a four-year college curriculum with a major in medical, biological, physical, health, pharmacy, or other related sciences, and a minimum of five years as a Clinical Research Associate.

• OR a two-year college curriculum or equivalent education/training, with at least seven years as a Clinical Research Associate.

• Willingness to travel.

• Valid current passport.

• Driving license.

• Proficient in the local languages of the countries managed.

• Fluent in both spoken and written English.

• Extensive knowledge of clinical research principles and processes.

• Comprehensive understanding of FDA and/or EU directives and regulations, ICH guidelines, and local regulatory requirements.

• In-depth knowledge of two to three therapeutic areas.

• Familiarity with standard operating procedures.

• Proficient in Microsoft Office.

• Proficient with IxRS and EDC systems.

• Outstanding oral and written communication skills.

• Strong planning, organizational, interpersonal, time management, initiative, and problem-solving abilities.

🏝️ Benefits

• A diverse and inclusive workplace.

• Supportive and collaborative teams.

• Accessible leadership.

• Equal employment opportunities.

• A workplace focused on employee experience.