Director, Early Phase Clinical Trials at Flourish Research

San Antonio, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Feb, 26

Salary

0.0

Posted On

03 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Leadership, Project Management, Regulatory Compliance, Data Integrity, Budget Management, Sponsor Relationship Management, Team Coordination, Training, Communication, Problem Solving, Operational Excellence, Therapeutic Area Knowledge, Audit Readiness, Performance Management, Documentation Management

Industry

Biotechnology Research

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 Director, Early Phase Services at our San Antonio site! The Director, Early Phase Services, leads our San Antonio site's early-phase portfolio. The Director builds and coaches the early phase services team to achieve enrollment, quality, and timeline goals. As the operational owner from start-up through close-out, they ensure SOP/FDA/ICH/GCP/HIPAA/IRB compliance, keep PIs engaged, and maintain clean source/EDC with rapid resolution of monitoring findings. They serve as a strategic partner to sponsors/CROs and to Regulatory, Lab, Pharmacy, and Business Ops, selecting studies, shaping budgets/amendments, and forecasting visits, revenue, and profitability. The outcome: a scalable program that grows the Early Phase business while protecting subject safety and data integrity. Location: 5430 Fredericksburg Rd #200, San Antonio, TX 78229 Schedule: Normal Business Hours, Monday-Friday or as needed with travel up to 30-40% Compensation: Competitive Base Salary + Bonus (Annual + Quarterly) 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; review daily rosters; provide backup coverage to keep work accurate and on time. Drive project delivery to meet enrollment, quality, and timeline targets; surface risks early and keep objectives on track. Enforce SOP/FDA/ICH/GCP/HIPAA/IRB requirements; protect confidentiality and maintain audit readiness. Oversee start-up through close-out; coordinate team schedules, resources, and meeting cadence (PSVs, recruitment, budget, and team meetings). Partner with PIs/Sub-Is and clinical teams to ensure high PI engagement and subject safety; communicate frequently and train as needed. Maintain data integrity and source/EDC quality; review data collection/entry, monitor reports, and follow-up letters; resolve findings promptly. Cultivate sponsor/CRO relationships; serve as a primary interface during monitoring and study activities. Collaborate on initial and amended budgets/contracts; meet team budget and revenue goals. Forecast visits, revenue, and profit; set departmental goals to achieve financial, enrollment, and quality outcomes. Hire, train, mentor, and supervise Assistant Director, Operations Supervisor, and clinical/PRN staff; conduct performance reviews and coaching. Manage PRN training and scheduling; optimize coverage to support throughput. Lead study and team communications; provide timely written/oral updates to executives, supervisors, and direct reports. Identify department needs for Business Development and contribute to process/operational improvements. Attend manager trainings and required planning meetings; model professional conduct and confidentiality. Other responsibilities as assigned by senior leadership or as needed to achieve quarterly/annual goals for early phase services. QUALIFICATIONS Bachelor’s degree required; advanced degree a plus. 5+ years site-side clinical research experience with 3+ years people leadership (CRC/CRCA/PRN teams); early-phase experience required. Proven delivery across the study lifecycle (start-up → close-out) with a track record of ~20+ early-phase studies led/contributed. Working knowledge of FDA/ICH-GCP, IRB requirements, HIPAA, and site SOPs; audit/inspection readiness mindset. Strong clinical/operational skills (e.g., ECGs, vitals, medical histories, sample/specimen handling) and source/EDC data accuracy. Proficient with CTMS/EDC and Microsoft Office; RealTime experience strongly preferred. Demonstrated ability to manage heavy documentation, resolve queries on time, and maintain data integrity. Experience engaging PIs/Sub-Is and coordinating with Regulatory, Lab, and Pharmacy to protect subject safety (AE/SAE reporting). Sponsor/CRO relationship management and monitoring visit support (prep, follow-up, issue resolution). Budget and forecast familiarity; able to set goals and meet enrollment, quality, and financial targets. Talent development: hiring, training, mentoring, and performance management. Excellent written and verbal communication; professional conduct and strict confidentiality. Therapeutic area experience preferred: cardiology, renal, pulmonary, infectious disease, neurology (open to others). Site-side background required; CRO backgrounds considered when tied to site operations. Willingness to travel ~30–40% across the Early Phase network; primarily on-site in San Antonio with limited hybrid flexibility. Willingness to work outside core hours (evenings/overnights/weekends) as study needs dictate. Ability to lift ~35 lbs and stand for prolonged periods; valid driver’s license and reliable vehicle access. 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! 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.

Responsibilities

The Director leads the early-phase portfolio at the San Antonio site, ensuring compliance and achieving enrollment, quality, and timeline goals. They also manage team operations, cultivate sponsor relationships, and oversee project delivery from start-up through close-out.