Beschreibung

As a Clinical Research Associate, you will engage in a variety of tasks, including conducting compliance visits and managing site relationships to ensure trials run smoothly and data remains accurate. This role involves problem-solving and collaboration to uphold the highest standards in clinical research.

Anforderungen

• •Bachelor's degree in life sciences or Registered Nursing certification or equivalent
• •Previous experience comparable to 1 year as a clinical research monitor or completion of PPD Drug Development Fellowship
• •Valid driver's license where applicable
• •Proven clinical monitoring skills
• •Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• •Demonstrated ability to maintain knowledge of ICH GCPs and applicable regulations
• •Well-developed critical thinking skills
• •Ability to manage Risk Based Monitoring concepts and processes
• •Good oral and written communication skills
• •Ability to maintain customer focus with good listening skills
• •Good organizational and time management skills
• •Effective interpersonal skills
• •Attention to detail
• •Ability to remain flexible and adaptable
• •Ability to work in a team or independently
• •Good computer skills: knowledge of Microsoft Office and ability to learn software
• •Good English language and grammar skills
• •Good presentation skills

Aufgaben

• •Perform and coordinate clinical monitoring and site management
• •Conduct remote or on-site visits to assess compliance with protocols and regulations
• •Manage procedures and guidelines from various sponsors and monitoring environments
• •Ensure trials adhere to approved protocols, ICH-GCP guidelines, and applicable regulations
• •Maintain audit readiness and build relationships with investigational sites
• •Monitor investigator sites using a risk-based approach
• •Apply root cause analysis to identify and resolve site process failures
• •Ensure data accuracy through review of SDR, SDV, and CRF
• •Assess investigational products through inventory and records review
• •Document observations in reports and letters using approved standards
• •Escalate deficiencies and issues to clinical management promptly
• •Maintain regular contact with investigative sites between monitoring visits
• •Conduct monitoring tasks per the approved monitoring plan
• •Participate in the investigator payment process
• •Collaborate with project team members on issue resolution
• •Investigate and follow up on findings as necessary
• •Participate in investigator meetings as needed
• •Identify potential investigators in collaboration with the client company
• •Initiate clinical trial sites to ensure compliance with protocols and regulations
• •Perform trial closeout and retrieve trial materials
• •Ensure essential documents are complete and compliant with ICH-GCP
• •Conduct on-site file reviews as per project specifications
• •Provide trial status updates to the Clinical Team Manager
• •Update study systems according to agreed conventions
• •Facilitate communication between investigative sites, the client company, and the project team
• •Respond to company, client, and regulatory requirements and audits
• •Complete administrative tasks such as expense reports and timesheets
• •Assist in preparing project publications and sharing ideas with team members
• •Contribute to process improvement initiatives as required