• Top Performer who boasts a record of proven business results in the start-up, reorganization, and revitalization of research centers, and who makes sound decisions to rexxxxxxect positively on operations in alignment with a company s vision and goals to attain a competitive advantage with recognition for transforming systems profits and productivity.
• Visionary Professional with commendable accomplishments across multifaceted research center sites, and who rises above challenges to increase revenue, streamline processes, improve efficiencies, and drive winning facility outcomes.
• Bilingual Communicator (English / Spanish) who builds synergistic relationships with C-level executives, decision-makers, research / business staff, and vendors, and who excels in autonomous and collaborative work environments.

  Generated year-over-year revenue gains and profits at a steady 20% return.

  Maximized cost savings and efficiency by restructuring multifaceted division operations.

  Integrated four operational divisions within the company to work in a more cohesive manner.

  Successfully established a neurology clinic and developed a financial structure to foment key growth.

  Developed strategic alliances with sponsors and CRO representatives quickly restoring forward momentum.

  Turned around an underperforming cardiology division, including streamlining operations, reversing losses into profits, serving as catalyst for growth and expansion, and reestablishing business relations to improve all standings.

Chief Operating Officer (2015 Present)

  Capitalize on the opportunity to lead forward-thinking clinical operations and to continue the re-structuring of the business development department for the organization, including mentoring and managing performance of four clinic directors in multi-therapeutic research centers and managing a 55-member research team to meet or exceed goals.

  Initiated business solution software to streamline business operations.

  Led acquisitions negotiations and forecasted resurgence of R&D in new therapeutic areas.

  Served as an intermediary during merger and acquisitions negotiations of research centers.

  Hand-selected by physician partners to lead clinical operations and continue business restructuring.

  Spearheaded development of company intranet and SharePoint for integration and sharing of information.

Director of Business Development (2015)

  Strategically steered development of newly acquired research centers and oversaw the restructuring of underperforming centers, including creating a plan to move the company into a position of less dependence on brokers.

  Developed a new database of study liaisons and pharmaceutical and biotech representatives.

  Developed and enhanced a website promoting multi-clinic capabilities and therapeutic areas of research.

  Promoted a sense of collaboration between clinical, business development, and marketing divisions by fomenting an environment to approach sponsor representatives from different perspectives and achieve new awarded studies.

Site Director Cardiology Division (2011 2015)

  Led clinic operations, including managing contract and budget negotiations, as well as developing scope of services.

  Managed clinic s financial audits by reviewing study budgets, contracts, and account receivables to ensure invoices were up-to-date and sponsor payments were reconciled, and further coordinated efforts with the regulatory department to ensure documents (e.g. licenses, certifications, delegation of authority forms, 1572s) were up-to-date.

• Spearheaded comprehensive internal auditing of all research subject binders and CRFs to ensure that previous and / or current studies were effectively conducted in accordance to protocols, FDA, GCP, and ICH guidelines.
• Drove clinic success by recruiting, training, mentoring, and managing a team of top-performing site personnel.

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Site Director Cardiology Division (continued)

  Led efforts to revise and develop new SOPs specifically tailored for the clinic.

  Led restructuring efforts to develop a more aggressive and successful business model.

  Involved in the development of patient recruitment strategies to meet enrollment goals.

  Created materials for clinical training sessions for wide-ranging distribution to clinic professionals.

  Developed an invoice and patient activity tracking system to ensure all site activity was accounted for.

  Expanded company into Latin America while building relations and seeking new study placement opportunities.

Site Director

  Led targeted decision-making across high-volume institute operations, including directing business development, financial structuring, and overall establishment of the clinic, as well as building relationships with sponsors and vendors.

  Directed a details-driven team of personnel, including handling all training / development and performance reviews.

  Cost-effectively handled budget and contract negotiations with sponsors and sponsor s representatives worth several hundred thousand dollars, and further negotiated contracts which were consistent with the site s financial forecasts.

  Negotiated, analyzed, and ensured accuracy of Clinical Trial Agreements (CTAs) for compliance with critical laws.

  Developed SOWs and contract terms / conditions, along with establishing investigator and vendor relationships.

  Established the site s budget template and financial metrics.

  Led SOPs development team in comprehensive site compliance initiatives.

  Initiated a quality control system as quality control department lead for ongoing site studies.

  Ensured all procedures were continually conducted in accordance with local and federal laws and regulations.

Research Department Leader

  Maximized research success as a results-generating liaison between management and research coordinator department staff, including assisting site director with personnel performance reviews to align with research goals.

  Spearheaded chart review and inclusion / exclusion criteria verification for potential subject enrollment, along with assisting site director in managing studies conducted and providing study enrollment, screening, and development.

  Personally screened and interviewed potential study participants for optimal research success.

  Performed infusions of the study medication with responsibilities in overseeing the pharmacy department.

Clinical Research Coordinator

  Expertly consented, screened, and enrolled study participants per protocol and GCP and ICH regulations, including coordinating protocols to meet established standards in compliance with laws, regulations, policies, and procedures.

  Successfully handled high-volume data entry, acquired laboratory samples, and performed EKGs.

  Reviewed source documentation, case report forms, and data reports for accuracy and timely submission.

Clinical Research Coordinator

  Demonstrated solid communications skills toward supporting and conducting research for assigned study protocols with careful monitoring of key research participants and procedures under the guidance of the principal investigator.

  Optimized multi-project administrative efficiency by handling overall study drug accountability and recordkeeping.

  Collaborated with key investigators to quickly resolve discrepancies with data collection.

  Personally recognized challenges and actively recommended corrective and prevention actions.

Clinical Research Coordinator

  Played a vital role in managing high-level research studies while developing comprehensive source documentation.

  Enrolled and followed patients through clinical procedures, including collecting data and managing projects for study.

  Led protocol procedural compliance to ensure timely submission of documentation and data accuracy.

Bachelor of Science in Business Leadership & Organizational Management Xxxxxx Atlantic University