Specialist Regulatory Administrator-Miami

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you!

QPS’ Story :

Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of services, including Early Phase Clinical and Phase II IV Clinical Research services.

The QPS location in Miami, Florida is a multi-specialty research center employing clinical research professionals, including board-certified physicians, in a 32,000 square foot space.

To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.

Team members enjoy challenging and rewarding work, and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, team work and a friendly atmosphere where performance is recognized and rewarded.

We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals.

If this sounds like your ideal work environment, then we would love to speak with you, so apply today!

Please visit our website (www.qps.com) for more information and to see all current openings.

The Job

• Communicate with Site Administrators, Sponsors, IRBs, Investigators, and Staff.
• Receive and set up files on all prospective and current studies that have been selected for regulatory submissions.
• Provide copies of new study Protocols to Medical Director, Principal Investigator, Finance Department, and Marketing Department.
• Contact Sponsor / CRO to confirm receipt of initial regulatory package.
• Complete Initial Regulatory Documents (i.e. FDA 1572, Financial Disclosure Forms, IRB Submission, GCP certificates, licenses, CVs, etc.) for PI and Sub-Is.
• Submit Initial Regulatory Documents to appropriate personnel as stated in cover letter of the regulatory package.
• Submit Site-Specific Study Materials (e.g. Phone Screen, Subject Instruction Sheet, and ICF Understanding Questionnaire) to Sponsors and IRBs for approval prior to use.
• Submit Site-Specific Advertisements (e.g. Print, Radio, TV, and Digital Ads) to Sponsors and IRBs for approval prior to use.
• Confirm the Subject Compensation Schedule and Language with both the Finance Department and the Sponsor.
• Submit revisions to the Informed Consent Form and other pertinent site changes to the IRB, if applicable.
• Prior to study commencement, meet with designated Study Coordinator(s) to provide them with regulatory documents for insertion in the Regulatory Binder.
• Update Regulatory Tracker on a daily basis in order to have most recent and accurate information pertaining to the start-up process for each study.
• Communicate with Study Coordinators to ensure that regulatory documents have been received, and note which documents are still pending.
• Meet and communicate / follow-up with Recruitment and Marketing Departments to discuss the approval status of Site-Specific Advertisements.
• Continually follow-up with sponsors and IRBs to ensure all regulatory documents have been submitted (if they are doing on the site’s behalf) or are still being reviewed and may require edits / changes.
• Forward IRB notifications / correspondence with downloaded attachments to Lead Study Coordinator and appropriate staff.
• Respond to Sponsor / CRO and IRB questions regarding regulatory documents and study submissions in a timely manner.
• Initialize and maintain a continuing update of all required Institution, Investigator, and Site Staff credentials (e.g.

updating CVs, and gathering new licenses and GCP certificates).

• Supervise and establish a paper-flow / email-trail for regulatory documents.
• Be responsible for the review of all regulatory documents (including the review of approved Informed Consent Forms for required elements, an accurate compensation schedule, and all site-specific documents and advertisements) prior to turning them over to the Lead Study Coordinator.
• Be responsible for advancing and monitoring the flow of all Site-Specific Documents / Advertisements between Study Coordinators / Marketing Department and Sponsors / CROs / IRBs.
• Mediate and / or mitigate issues between Study Team and Sponsor / CRO on an ongoing basis throughout the length of the study.
• Maintain an up-to-date list of studies that have been conducted at the site.
• Assist Director of Business Development by providing staff credentials and up-to-date regulatory information for each study.
• Perform all other duties assigned by the Executive Director of Clinical Operation.

Requirements

• Strong grasp of FDA regulations, the drug development and research process, GCP and ICH guidelines, and company SOPs.
• Computer skills (MS Office Word, Excel, and Outlook along with other programs such as PDF editors).
• Familiarity with relevant software for clinical research (e.g. Clinical Conductor).

Why You Should Apply

• Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
• Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
• Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life / AD&D and Short and Long-term Disability Insurance

QPS is an Equal Employment Opportunity / Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law.

Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.