Job Description

PRINCIPAL DUTIES & RESPONSIBILITIES

• Serves as primary Sponsor/CRO and PI/site contact on submissions that are assigned to you, and assists with studies as needed
• Conducts an administrative review of Protocol/site submissions by reading, reviewing, and understanding protocol requirements and all supporting documentation
• Documents and executes client customizations as requested; processes change requests for approved Protocols
• Manages vendor relations and documentation for foreign language translations
• Maintains a high level of accuracy and attention to detail and collaborates with the quality assurance team to ensure a minimal rate of error
• Completes work in a timely manner, responding to customers within 24 hours of email/voicemail receipt
• Escalates any customer or timeline issues to management
• Assists with process improvement initiatives
• Attends conferences and workshops
• Other duties as assigned

Education

• Certified IRB Professional (CIP) or attainment of CIP within one (1) years of eligibility (preferred)

Experience

• Two (2) years of experience in an office environment (preferably in a regulated industry)

Knowledge, Skills, Abilities

• Federal laws and guidelines pertaining to Research and the Use of Human Subjects including the FDA and DHHS
• Write and speak in English to compose business text such as letters, memos, e-mails and reports; copy or transcribe information; summarize or condense information; edit, revise, correct, proofread
• Word process and type
• Listen, understand and interpret scientific and medical dialogue to be able to quickly and accurately communicate IRB determinations to clients.
• Read and understand research texts such as medical protocols and Informed Consent Forms.
• Must have high level of attention to detail, accuracy and thoroughness; Problem solving skills
• Highly organized and efficient; Process and procedure oriented
• Excellent interpersonal skills to work professionally and effectively with others and provide high levels of customer service
• Communicate clearly and professionally, both verbally and in writing; public speaking
• High level of professionalism
• Ability to follow written and verbal instructions and work independently as required plan, organize, schedule and complete work within deadlines
• Ability to manage conflicting demands and priorities
• Ability to adapt to changes in office technology, equipment and/or processes
• Demonstrated consistency and dependability in attendance, quantity and quality of work

PHYSICAL AND MENTAL REQUIREMENTS:

Sit or stand for extended periods of time at stationary work station

Regularly carry, raise, and lower objects of up to 10 Lbs.

Learn and comprehend basic instructions

Focus and attention to tasks and responsibilities

Verbal communication; listening and understanding, responding and speaking

EEO STATEMENT Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated. EEO/M/F/Disabled/Vets