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CLINICAL OPERATIONS SPECIALIST – TEMPORARY
Assists with the planning and execution of clinical trials in Phase I-IV. Participates in study set-up, site training, management of clinical vendors including CROs, central labs, eDC etc. Supports generation of new documents and maintenance, including SOPs, study protocols, reports etc. by writing, reviewing, and contribution.
• Assists with coordinating the planning and execution of clinical studies according to Argos’ SOPs and best practices.
• Point person and author in the generation of the operational parts or study protocol, study manual, informed consent, CRF, and other study related materials and forms.
• Assists in the selection of CROs and other vendors involved in handling Argos’ clinical trials.
• Instrumental in all study and site management activities, including start up, site initiation, monitoring, CRF design, review and data analysis, close out, etc.
• Facilitates subject registration and scheduling.
• Reviews monitoring reports and other study-related documents submitted by CRO.
• Supports the development and maintenance of Clinical Standard Operating Procedures (SOPs); this may include active authorship.
• Acts as back-up for other Clinical Department personnel, and performs co-monitoring of sites, as needed.
• Other duties as requested.
• Bachelors degree in a scientific discipline or equivalent combination of education and experience, with 3 - 5 years experience in the clinical research field, and/or experience in the CRO environment.
• Thorough knowledge of the drug development and clinical research processes, FDA/ICH GCP regulations and guidelines.
• Desired qualification - knowledge and experience of clinical monitoring (site initiation, routine and close out)
• Excellent written and verbal communication skills and sound interpersonal skills.
• Ability/willingness to travel as required
We offer a competitive compensation package along with outstanding benefits.
For confidential consideration, please
a resume with a cover letter and salary
No phone calls please.
Argos Therapeutics is an Equal Opportunity Employer.