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CLINICAL OPERATIONS SPECIALIST – TEMPORARY

SCOPE:
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.

RESPONSIBILITIES:

• 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.

QUALIFICATIONS:
• 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 history.

No phone calls please.

Argos Therapeutics is an Equal Opportunity Employer.