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Senior Clinical Research Associate FSP Clinical

Parexel International Corporation

USA - Any Region - Home Based

Position Purpose:

The Oversight CRA is a senior level Clinical Research Associate (CRA) responsible for performing Clinical Research Organization (CRO) monitoring oversight for sponsored outsourced studies. This includes conducting on-site oversight visits at investigator sites identified by Sponsor.

Organizational Relationships:

• Reports to assigned ExecuPharm (EP) Line Manager with day-to-day direction

• Liaises with internal and external stakeholders (e.g. study sites, vendors, committees, etc.) in support of clinical study objectives as required.

• Interfaces with cross-functional study team members in a matrix environment (e.g. data management) as appropriate.

Primary Duties:

• Reading and understanding all study-related material and function-related SOPs

• Conducting planned and unplanned visits to assess CRO CRA and Investigative Site performance according to applicable SOPs and study-specific plans

• Preparing confirmation and follow-up letters in accordance with the applicable Regeneron SOPs and study-specific plans

• Identifying potential performance deficiencies (CRO CRA and Investigative Site)

• Preparing visit reports according to applicable SOPs and study-specific plans

• Interacting with the Oversight Coordinator to ensure the proper scheduling of visits

• Recommending CRAs / Investigative Sites that may require an assessment

• Interacting with the study team to communicate visit findings, and CRO representatives, when necessary, to ensure program success through ongoing communication

• Attendance at functional and study-specific meetings as required

• Completes training assigned by ExecuPharm (EP), as necessary, including general training requirements, SOPs, and system and process related training

• Adheres to ExecuPharm SOPs and processes

• Travel to study sites as requiredQualificationsSkills and Education:

• Bachelor’s degree is required

• Minimum of 5 years relevant industry experience is required

• Problem solving abilities, troubleshooting and resourcefulness

• Analytical problem-solving experience

• Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable

• Effective communication and interpersonal skills; ability to build relationships internally and externally

• Familiarity with medical terms

• Demonstrate writing skills to deliver messages effectively so messages are clearly understood

• Proficiency in Microsoft Office applicationsEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2021-05-15

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