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Clinical Research Associate/Sr. Clinical Research Associate
1 month ago
We are a leading provider of innovative clinical trial and research services, established in 2005. Our mission is to accelerate the delivery of novel therapeutic treatments by conducting efficient and ethical clinical trials.
KlinEra has extensive experience in a diverse range of therapeutic areas, ensuring compliance and facilitating optimal delivery. Our network of Key Opinion Leaders and established relationships with Investigators enables expedited enrolment and quality results.
Job ResponsibilitiesThe Clinical Research Associate will report directly to the Clinical Operations Manager and serve as the primary representative and point of contact for clinical sites participating in our research studies.
- Conducting Qualification, Initiation, Interim Monitoring, and Close-Out Visits.
- Overall site management, driving recruitment, enrolment, and quality performance at clinical sites in accordance with GCP, ICH, and KlinEra's SOPs.
- Attending Investigator Meetings and participating in feasibility assessments, process development, and eTMF quality assurance.
Monitoring
- Monitoring clinical studies remotely and through on-site visits.
- Acting as primary liaison between study site staff and KlinEra.
- Reviewing source data and case report forms for accuracy, completeness, and integrity of the data.
Communications/Management
- Visit report writing and site correspondence.
- Interacting with clinical site study team through formal communications.
- Maintaining regular communication with the Manager to report on site performance.
Requirements
We are looking for a detail-oriented individual with extensive Phase I, II, and III experience in oncology trials. Excellent organisational and communication skills are essential. Ability to efficiently perform and prioritise multiple tasks is also required.
