Assistant Director - Early Phase Services
hace 2 días
San Antonio
Job Description Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We have an opening for our Assistant Director of Early Phase Services at our San Antonio site! The Assistant Director of Early Phase Services drives the execution of early-phase studies by leading team operations, setting schedules and resource plans, and coaching CRC/CRCA/PRN staff to hit enrollment, quality, and timeline goals. As the operational partner to Regulatory, Lab, Pharmacy, and Business Ops, they enforce SOP/GCP/ICH/HIPAA compliance, own visit tracking and source/data integrity, and steer start-up through close-out (budgets, supplies, pharmacy coordination, consent/stipends) while problem-solving in real time. They cultivate sponsor/CRO and investigator relationships, guide recruitment strategies, perform periodic QC, and develop talent, building a reliable, scalable engine for early-phase delivery. Location: 5430 Fredericksburg Rd #200, San Antonio, TX 78229 Schedule: Normal Business Hours, Monday-Friday or as needed Compensation: Up to $90k base salary Benefits: Health, dental, and vision insurance plans, 401(k) with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES • Lead day-to-day Early Phase operations; set schedules, allocate resources, and coach CRC/CRCA/PRN staff; provide coverage during absences., • Drive project execution to hit enrollment, data quality, and timeline targets; oversee visit tracking and EDC/RealTime updates with on-time query resolution., • Enforce SOP/GCP/ICH/HIPAA compliance; perform periodic QC, address protocol deviations, and implement CAPA to maintain audit readiness., • Manage study start-up through close-out (feasibility input, SIV prep, source development, visit workflows, final reconciliation) and keep timelines current., • Partner with Regulatory Affairs on consents, training records, essential documents, and subject stipend workflows to ensure complete, inspection-ready files., • Coordinate with Pharmacy and Lab on IP handling, kit/supply management, sample processing, and chain-of-custody; review study meal/supply budgets., • Collaborate with PI/Sub-Is and Nursing to protect subject safety; escalate AEs/SAEs promptly and ensure timely documentation and follow-up., • Support recruitment plans to achieve screening/randomization goals; review recruitment and PRG materials for accuracy and feasibility., • Build and publish staff rosters (including overnights), shift plans, and visit coverage; optimize PRN utilization and reduce overtime., • Hire, train, and develop team members; maintain training matrices, conduct performance reviews, and deliver coaching for skill and career growth., • Track operational KPIs (screen fail rate, visit cycle time, query aging, data timeliness); surface risks early and drive cross-functional mitigations., • Lead study and team meetings; communicate priorities, decisions, and action items; ensure timely follow-through and documentation., • Maintain professional conduct and confidentiality; represent the organization positively with sponsors/CROs and site partners., • Identify process improvements; propose and help implement SOP/workflow updates to scale throughput without sacrificing quality., • Other responsibilties as assigned by leadershipQUALIFICATIONS, • Bachelor’s degree or higher., • 3+ years of previous management experience (required)., • 1+ year conducting or managing clinical pharma/device research (preferred)., • Early Phase management experience (preferred)., • Working knowledge of federal regulations/ICH-GCP, IRB requirements, HIPAA, and internal SOPs., • Strong clinical skills (e.g., ECGs, vitals, medical histories, specimen collection/processing)., • Proven ability to manage heavy documentation accurately and on time., • Ability to organize people and resources and deliver to timelines with high accuracy., • Proficient with Microsoft Office, sponsor data entry/EDC systems, and RealTime., • Experience training and mentoring new hires/team members., • Professional communication and conduct; maintains confidentiality and HIPAA compliance., • Willingness to travel (local/US; occasional international) and work outside core hours as needed. Flourish Research is where clinical trials thrive. Flourish 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. 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 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. Flourish 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! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Powered by JazzHR k2hwdN1snR