Regulatory Specialist

Flourish Research•Denver, CO

2d•$34 - $41•Onsite

About The Position

Valkyrie Clinical Trials (VCT), a Flourish Research Company, is a leading Oncology multi-site clinical research network with expertise in Oncology research. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California in Century City, Panaroma City, and Murrieta, and has recently expanded to Denver, Colorado. Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! We are actively hiring a Regulatory Specialist to support our Clinical Research site in Denver, CO.

Requirements

High school diploma or equivalent required; college degree preferred
1–3+ years of experience in clinical or biological research
Must be experienced with Microsoft office applications (Outlook, Word and Excel) as well as a CTMS system, eRegs/eDocs, and other internet-based platforms.
Must be detail oriented, organized, self-motivated, be able to work independently and on a team, as well as the ability to stay on task and meet deadlines.
Must possess excellent interpersonal skills including written and verbal communications.
Is moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite sites and other employees.
Must have good critical thinking and problem-solving skills.
Must be professional and have a strong work ethic.
Must have the ability to adapt and take on additional tasks as requested.
Ability to problem solve while working closely across departments.
Assists with key initiatives/process improvements in the department.
Assists with training company new hires.
Completes at least 80% of goals annually.
Excellent computer skills to include Office365 products.

Responsibilities

Prepare, maintain and provide oversight to all research-related regulatory documents.
Populate and coordinate the entire process of initial regulatory documents submission to the IRB, sponsors and state or federal regulatory offices as necessary.
Compile study information and submit initial, continuing and final reorts to the IRB and/or sponsor.
Prepare applicable submission forms and submit updated documents including but not limited to Amendments, Addendums, Investigator’s Brochures, Safety Information, Form FDA 1572s and informed consent documents.
Accurately file and maintain all necessary logs within the appropriate regulatory repositories.
Assist in and manage the archival of clinical trial documents/records.
Prepare for monitoring visits and audits.
Distribution, collection, processing, and tracking of Essential Site Regulatory Documents for all ongoing studies, including collection of updated Investigator, Pharmacist, and nursing CVs, licenses, GCP, IATA, and training certificates, as applicable. This process applies to both paper and electronic files for each study at the site.
Maintain confidentiality of study protocol information and Protected Health Information (PHI).
Create error-free written documents and reports (e.g., cover letters, notes-to-file, memos, etc.).
Perform all duties in a safe and prudent manner.
Perform all study related duties in a time-and-cost effective manner in adherence with Flourish policies.
Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with Flourish staff, sponsors, contract research organizations (CROs), IRBs, participants, nursing and medical staff members of various clinics, hospitals and physician’s offices; Flourish Research contract personnel, as well as any other person(s) when carrying out task and responsibilities.
Additional duties as assigned by management.