Job Overview Summary The Sr Coordinator is responsible for providing exemplary client service and serves as the main point of client contact for designated pharmaceutical companies, contract research organizations, and academic medical centers. This position will provide direct client assistance and advisement to facilitate IRB review and translates IRB decisions and processes to clients to maintain continuity and timely communications.
Job Duties & Responsibilities - Serves as the main Sponsor/CRO and PI/site contact on assigned studies
- Manages the day-to-day relationship for assigned top tier accounts
- Manages review of Protocol/site submissions by reading, reviewing, and understanding protocol and all supporting documentation
- Demonstrates an advanced understanding of multiple types of Protocol and Site Submissions
- Documents and executes client customizations; processes change requests
- 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
Location This role is open to candidates working remotely in the United States.
Basic Qualifications - Bachelor's degree or four years of equivalent experience
- Four (4) years' experience in IRB or clinical research setting that includes applying regulations to the protection of human subjects
Preferred Qualifications - Certified IRB Professional (CIP) or attainment of CIP within one (1) years of eligibility
- Intermediate computer skills, including proficiency with MS Office Suite with an emphasis on Word and Outlook
- Ability to effectively use proprietary system
- Knowledge of 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
- 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 and discretion with all communication with clients
- Ability to follow written and verbal instructions and work independently as required to 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 workstation
- 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
Pay Transparency Statement The base salary range for this role is $66,767 - $119,089. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.
