Regional Regulatory Specialist - Full-time

pspan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"strongFlourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives!#160;#160;/strongWe offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.brbrbWe are actively hiring a Regional Regulatory Specialist at the Flourish Research site in Charlotte!/b/span/span/ppspan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"The Regulatory Specialist is responsible for managing and coordinating regulatory documents and activities for clinical research studies conducted at Flourish Research. This role involves working with site leadership, principal investigators, and regulatory bodies to ensure compliance with Flourish Research's standards, federal regulations, and sponsor protocols.#160;brbrbShift:/bstrong#160; /strongMonday - Thursday, 7:30 AM - 5 PM, occasional Fridays from 8 AM - 12 PM/span/spanbrspan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"strongLocation:/strong#160;#160;10801 Monroe Rd, Suite # 100, Matthews, NC 28105brstrongCompensation:#160;/strong $24-$29/hr based on experiencebrstrongBenefits:#160; /strongHealth, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays.brbrbRESPONSIBILITIES/b/span/span/pullispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Prepare, maintain, and oversee all research-related regulatory documents/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Manage the full lifecycle of regulatory submissions to IRBs, sponsors, and regulatory agencies/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Submit study updates, including amendments, safety info, FDA 1572s, and consent forms/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Maintain accurate logs and ensure proper regulatory filing and archival of documents/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Prepare for monitoring visits and audits/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Distribute, collect, and track essential site regulatory documents (CVs, licenses, training certs, etc.)/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Maintain both paper and electronic regulatory files for all active studies/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Ensure confidentiality of study protocols and Protected Health Information (PHI)/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Draft clear, error-free written communications and documentation/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Execute duties safely, efficiently, and in alignment with company policies/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Represent Flourish Research professionally in all internal and external interactions/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Perform additional duties as assigned by management/span/span/li/ulpspan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"bQUALIFICATIONS/b/span/span/pullispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"High school diploma or equivalent required; college degree preferred/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"0#8211;3+ years of experience in clinical or biological research/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Proficient in Microsoft Office (Outlook, Word, Excel) and platforms such as CTMS, eRegs/eDocs/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Highly detail-oriented, organized, and self-motivated/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Able to work independently and collaboratively in a fast-paced environment/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Strong written and verbal communication skills/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Ethical and professional in interactions with patients, sponsors, IRBs, and staff/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Strong critical thinking and problem-solving abilities/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Demonstrates a high level of professionalism and work ethic/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Flexible and willing to take on additional tasks as needed/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Effective at cross-departmental collaboration and issue resolution/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Contributes to departmental initiatives and process improvements/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Assists in training new team members/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Meets or exceeds 80% of annual goals/span/span/lilispan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Excellent computer skills, including proficiency with Office365/span/span/li/ulpspan style="font-size:14px;"span style="font-family:Arial, Helvetica, sans-serif;"Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!brbrbFlourish Research is where clinical trials thrive./bbrbrFlourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.brbrAt 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.brbrFlourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.brbrFlourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. 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!brbremFlourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.#160;/em/span/span/p