Barbara Arispe
Pflugerville,TX
Summary
Results-driven Business Development professional with a proven track record of success in the pharmaceutical industry, consistently driving revenue growth and cultivating trusted partnerships. Expertise in strategic planning, market analysis, and contract negotiation, with in-depth knowledge of regulatory frameworks and market access strategies. Recognized for a collaborative approach, adaptability in healthcare environments, and a strong commitment to achieving and exceeding performance goals. Versatile and solutions-focused, with the ability to manage multiple priorities while ensuring compliance and alignment with key performance indicators.
Overview
28
28
years of professional experience
1
1
Certification
Work History
Business Development/Training Manager
QCR Network
08.2023 - Current
- Create and manage all business development operations, work closely with internal management teams, ensure all prospective sponsors and clients are handled with the highest level of customer service and professionalism, and that quotas for future trials are met.
- Identify and secure new business opportunities by developing and maintaining study leads and client relationships.
- Attend conferences and exhibitions.
- Develop new business proposals and submit to relevant sponsoring pharmaceutical companies and CROs.
- Research Pharmaceutical and Biotech company pipelines for potential new business opportunities.
- Oversee the completion of feasibility forms.
- Identify potential study opportunities, considering enrollment timelines, competing trials, access to patient population
- Oversee the negotiation of contracts and change orders with CROs and sponsoring pharmaceutical companies.
- Maintain a comprehensive knowledge base of current and past study performance in enrollment and data quality in order to communicate effectively with clients.
- Training of all onsite staff.
- Onboarding new PI’s and Sub-I’s.
- Acquiring new sites/clinics and Physicians.
- Assisting with creating and writing of SOP’s and training materials.
Site Manager
Care Access
08.2022 - Current
- Establish early lines of communication with the clinical teams as they are identified, and prepare for site activation.
- Establish timelines during the trial start-up cycle and then during subject accrual, assuring that monthly enrollment goals are met each month.
- Assist with site feasibility evaluations, detailing the availability of critical local resources necessary to be successful at activating trials and enrollment and protocol performance once a trial begins.
- Assist site in central IRB on-boarding, ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
- Oversee site compliance with investigational products, reporting or safety events and contracting.
- Oversee site performance, assist with subject eligibility and randomization, identify recruitment problems, personalize remediation programs with site team, and help to assure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion.
- Conduct weekly (or more frequent) teleconferences and manage monthly training broadcasts with the clinical teams and individually mentor new coordinators and investigators.
- Maintaining enrollment and clinical teams on schedule with established performance expectations.
- Provide support to quality assurance monitors in all facets of work related to communications with and management of the enrolling center clinical teams.
- Responsible for managing site investigator relationships and executing site start up and performance plans, assigning tasks and deadlines to site clinical teams, directing and monitoring clinical site work efforts on a daily basis, identifying resource needs, performing quality reviews, and escalate functional, quality and timeline issues appropriately.
- Execute lean management processes and methodologies to ensure sites deliver on-time and within the budget, adhere to high quality standards, and benefit the investigative effort by ensuring smooth implementation of trial policies and goals from site launch through study activation and completion of the trial at the local levels.
- Performing audits performance of clinical sites/staff, and recommending changes to protocol operations based on audit results.
- Serve a critical role as liaison and facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist in the auditing and monitoring of study sites.
- Building and maintaining strong, trusting relationships.
- Training and development of new and current employees.
Physician Liaison Manager
SiteRx
08.2021 - 05.2022
- Monitor status of new physicians and providers.
- Maintain metrics for clinical excellence team and all nurse reviewers.
- Reviewed all audit sheets for each physician, and or provider integrated with SiteRx.
- Review patients charts for clinical trial consideration.
- Map out all physicians and providers based off of office location and study site locations.
- Increased strong relationships with physicians, providers, and all office staff.
- Report directly to physician team manager, key stakeholders and CEO any updates to study recruitment, metrics, patient retention, audit findings, study site availability, and any sponsor (Pharma) updates.
- Collaborated with teams on specific plans of action for study enrollment.
- Provided study inclusion and exclusion criteria to physicians and providers to ensure enrollment of high quality patients.
- Conduct training of clinical excellence team members.
- Managed relationship between US team and offshore (India) team.
PACU Nurse
Cardiothoracic and Vascular Surgeons
05.2016 - 07.2021
- Vital signs, IV access, lab collection, ECG's and assessed patients in recovery room following surgical procedures.
- Evaluated patients' pain levels, implementing correct dosage of medication to alleviate discomfort.
- Supported healthy working environment, adhering to patient safety protocol, complying with hospital policies and maintaining situational awareness.
- Kept meticulous charting notes regarding patient assessments and medications, later transferring information into records management system.
- Provided individualized care and dedicated oversight to patients in post-operative recovery room.
- Assessed and identified individual patient educational needs, removing barriers to learning and supporting comprehensive progress.
- Trained and coached new employees on protocols and best practices to promote ideal patient outcomes.
Clinical Research Coordinator II
Central Texas Clinical Research
05.2015 - 07.2017
- Worked directly with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Coordinated clinical trials focused on disorders such as DM, HTN, Obesity, HIV, and NASH.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Collected lab samples, specimen processing and packaging, ECG's, vital signs, urine pregnancy test, urine drug screen, alcohol breath test, and administration of various scales.
Clinical Research Coordinator/Site Manager
Discovery Clinical Trials
07.2014 - 05.2015
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Coordinated clinical trials focused on disorders such as DM, HTN, COPD, and Obesity.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Collected lab samples, specimen processing and packaging, ECG's, vital signs, urine pregnancy test, urine drug screen, alcohol breath test, and administration of various scales.
- Conducted study specific training for all staff.
Clinical Research Coordinator/Manager
Premier Research
10.1997 - 07.2014
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Oversaw all study related procedures to ensure compliance with local and federal regulations.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Participated in study initiation visits, monitoring visits and closeout visits to verify study procedures, regulatory documents and data completion were all per protocol.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study team and sponsor to troubleshoot and provide solutions to study-related issues.
- Mentored and conducted study specific training for all study team to deliver successful studies.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
- Collected safety data, vital signs, IV's, ECG's, pregnancy test, data entry into data collection systems, urine drug screens, alcohol breath test, specimen processing and packaging, and conducted various scales.
Education
Associate's degree - Nursing LVN
Career Point College
Austin, TX12.2015
Skills
- Vital Signs
- Medical terminology
- EMR Systems
- Recruiting
- Medication Administration
- Communication skills
- Computer skills
- Laboratory Experience
- GCP
- Clinical Research
- Microsoft Word
- Microsoft Excel
- Records Management
- Nursing
- Triage
- Office Management
- Spanish
- Data Collection
- Patient Care
- Organizational skills
- IVR
- Phlebotomy
- Written and oral communication
- Strategic thinker
- Exceptional communicator
- Adaptive learning
- Project management
- Leadership training
- Training facilitation
- Learning management systems
- Training oversight
- Staff development plans
- Resource management
- Business administration
- Needs assessment
- Public speaking
- Team development strategies
- Customer service
- Decision-making
- Staff development
- New hire training
- Quality control
- Workload management
- Staff leadership
- Relationship building
- Management team development
- Workflow process improvement
- Productivity improvement
- Daily schedule creation
Certification
- AED Certification
- Compact State Nurse License
- LVN
- BLS Certification
- CPR Certification
- GCP
Languages
Spanish
Professional Working
Business Development/Training Manager
Site Director, Study Start-Up, and Site Acquisitions.
Timeline
Business Development/Training Manager
QCR Network
08.2023 - Current
Site Manager
Care Access
08.2022 - Current
Physician Liaison Manager
SiteRx
08.2021 - 05.2022
PACU Nurse
Cardiothoracic and Vascular Surgeons
05.2016 - 07.2021
Clinical Research Coordinator II
Central Texas Clinical Research
05.2015 - 07.2017
Clinical Research Coordinator/Site Manager
Discovery Clinical Trials
07.2014 - 05.2015
Clinical Research Coordinator/Manager
Premier Research
10.1997 - 07.2014
Associate's degree - Nursing LVN
Career Point College
Similar Profiles
Quinn StevensQuinn Stevens
Talent Acquisition Specialist at QCR Holdings, Inc.Talent Acquisition Specialist at QCR Holdings, Inc.
RODERICK (ROD) OWENSRODERICK (ROD) OWENS
Sales Account Manager Recruiter at The Professionals Network Energy Network Med NetworkSales Account Manager Recruiter at The Professionals Network Energy Network Med Network
DAMION LEWINDAMION LEWIN
Freelance Senior Motion Graphic Designer at The CW Network, Amazon Prime, Netflix, NFL NetworkFreelance Senior Motion Graphic Designer at The CW Network, Amazon Prime, Netflix, NFL Network
Mamadou SyllaMamadou Sylla
Commercial Cleaner at Alimentation GeneralCommercial Cleaner at Alimentation General
Tracen MoralesTracen Morales
Volunteer at St Elizabeth Catholic ChurchVolunteer at St Elizabeth Catholic Church