A Proficient Site Enablement Solutions Lead that collaborates with the GPSS team along with project delivery teams to manage the coordination, planning, and implementation of Site Support Services and Patient Recruitment and Retention support/operational plans on large multi-region studies.
Skills
Project management
Customer relationship management
Employee management
Product knowledge
Agile work processes
Business development support
Project coordination
Experience
01/2021 to Current
Global Site Enablement Solutions LeadIQVIA – City, STATE,
Manage the scope of work, objectives, quality of deliverables, and other activities of assigned projects (based on scope, may co-manage or independently manage these projects).
Development of the business for projects in the United States and Canada.
Working with the European team’s as their developing business on projects in the U.S.
Work on Site Engagement and Optimization (SE&O) objectives to oversee the success of site’s engagement with patient recruitment and their weekly enrollment for the study in which they are recruiting for Provide project and team leadership for development and oversight/delivery of our site services that include direct engagement with sites to provide their staffing needs.
Leverage internal intelligence and work closely with internal departments such as HR, Talent acquisition, Clinical operations and IT to support and refine strategy on assigned projects.
Work closely with IQVIA’s legal team to prepare, negotiate and execute site agreement contracts.
Liaise with external vendors to hire required site staff - research assistants, study coordinators and study nurses and oversee the training.
Oversee the performance of the hired site team to ensure project objective success.
Communicate with sponsors, sites and project teams to implement and monitor impact of the site support services plans; make additional operational and tactical recommendations as needed based on study performance.
Maintain knowledge of current recruitment trends, vendors, and technologies to increase productivity of the team; recommend product and service enhancements and additional product and/or service development as needed.
Coach and mentor employees as they develop in their role.
06/2019 to 11/2020
Lead Research Coordinator/ Certified Ophthalmic Medical TechnicianVold Vision – City, STATE,
I lead 10 clinical research trials.
I handle all the contract trial agreements, study synopsis reviews, IRB approval paperwork, financial disclosure forms, regulatory documents, and manage these studies in their entirety from top to bottom.
Work with and under the direction of the Principal Investigator (PI) and clinical Research Director to discuss the direction of the department and its financials.
Im delegated as one of the Sub Investigators for the FDA clinical trial Hydrus Microstent CP 16-001 (Summit).
Training new research and general clinic personnel on different standards of procedure (SOP), research protocols, and ophthalmic equipment.
I’m in charge of implementing new research devices that are used for any new trial.
I also implement new SOP’s or updated SOP’s.
I work on the negotiations of our contract trial agreements (CTA’s) and maintain communication lines between sponsors and principal investigator.
Monitoring research budget and invoices for trials with the use of Excel spreadsheets.
I account for check stipends for patients enrolled in clinical trials.
I help the PI delegate and place coordinators as main points of contact on studies based on their experience, skill set, and compression of studies.
Schedule web conference and teleconference calls with sponsors for each study to stay up to date on the enrollment process and trial information.
Updating site log’s which includes: calibration log of clinical equipment, ID and IP logs, and temperature logs.
File all of the study data in the patient study and regulatory documents in regulatory binder including I perform all protocol required assessments (including but not limited to visual acuity assessment manifest refraction, intraocular pressure check, visual fields, OCT, and others) and assist physicians with patient evaluation, monitoring, and implementation of medical care plans.
Providing site representation for our site at sponsor meetings.
Work with project managers to collect all essential documents ensuring operation of clinical trials are in accordance with required FDA, IRB, and study guidelines.
Working with multiple different electronic data capture (EDC) systems to enter data for several studies in a timely manner.
06/2018 to 06/2019
Certified Ophthalmic MedicalTennessee Retina, Tech – City, STATE,
Worked diligently with 10 different Retina physician’s to make sure they had every
possible test and tool needed for examination of patients.
Obtain patient history to include the chief complaint, history of present illness, prior
health history, family health history, allergies and medications.
Performed visual acuity, amsler grid testing, confrontational field testing, tonopen and
applanation tonometry.
Also instilled dilating and antibiotic drops
Sterilized equipment, maintaining practice standards of sterile technique and infection
control
Maintained patient workflow.
E-prescribing new medications as directed by the physician
Complied with all legal and ethical requirements for medical documentation.
Alert
physician when medical record is incomplete or medical documentation contains
mistakes or inconsistencies.
Prepared patients for intraocular injections and assisted the physician with minor
procedures.
Utilized various ophthalmic medical equipment to do in depth diagnostic tests for
physicians such as but not limited to: OCT, Fundus Photography and fluorescein
Angiography.
Worked with electronic medical record systems for coding, inserting findings, and
diagnosis into patient charts.
Ability to develop and maintain strong relationships with physicians, coworkers, and
patients through my excellent written and verbal communication skills.
06/2017 to 06/2018
Certified Ophthalmic Medical Technician Arkansas Retina, Ophthalmic Medical Tech – City, STATE,
Helped physicians create ways to improve patient care through timely turnaround times for patient entrance and exit.
Establishing relationships with patients through work ups and diagnostic testing along with prepping procedures.
Communicating with pharmacies about patients' electronic scripts for medications.
Managed and maintained clinical flow by organizing patient care.
Triaging patients ranging from urgent to emergent.
Clinical Research Trail Experience: Lilly PYAB and PYAH, GSK Lithe Nimble, Zeiss Mel 90, Lasik Laser RxSight Light Adjustable Lense (LAL), Preserflo MicroShunt Extension Study, IStent Inject, Trabecular Micro Bypass System continuation Post Approval Study, Xen-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold Standard Pathway Study, (GPS) Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Cohesive (CVisc50) OCS-01 OPhthalmic Suspension Prospective, Multi-Center, Single-Arm Post-Market Study of use The OMNI Surgical System in Combination with Cataract in Open Angle Glaucoma GC-011: A Prospective, Multicenter Clinical Investigation of the Glaukos Trabecular Micro-Bypass System, Model IS3, in Subjects with Refractory Glaucoma Prospective, Randomized Phase 3 Study Comparing Two Models of a Timolol Maleate Ophthalmic Solution, USP 0.5% CT Lucia 611 Posterior Chamber Intraocular Lens for Correction of Aphakia following Cataract Removal, Allergan Confidential- RGH-MD-24 & 25 Bipolar Hydrus Microstent for Refractory Open Angle Glaucoma (SUMMIT).
Education and Training
Expected in 05/2017
Bachelors of Science: Ophthalmic Medical Technology University of Arkansas Medical Science - Little Rock, AR GPA:
Expected in 10/2021
: - , GPA:
Certifications
Certified Ophthalmic Medical Technician COMT- July 2018- 2021
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University of Arkansas Medical Science
Job Titles Held:
Global Site Enablement Solutions Lead
Lead Research Coordinator/ Certified Ophthalmic Medical Technician
