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Clinical Research Support

Location:
San Antonio, Texas, United States
Posted:
November 14, 2017

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Teresa (TERRI) Llanas, LVN

Woodbridge Condominiums Mobile: 210.***.****

**** ********** **. **** ** Email: ac3bgo@r.postjobfree.com

San Antonio, Texas 78209

Professional Experience

President/Clinical Director Multi-Phase Trials, LLC

February 2015 – Present San Antonio, Texas 78217

Instrumental in the acquisition of clinical studies for the conduct of biologic and device trials. Collectively work with US and International Pharmaceutical Companies to acquire new studies and work to draft the necessary support needed for the conduct of the proposed study. Presented and submitted sites capabilities and past experience for support of granting new studies. Review of contractual agreement for legal obligation and outline stipulation for scope of work as reflective of the final contract and budget to reflect the level of work as outlined in the protocol as dictated by the FDA for an outpatient private practice setting. Work with the Institutional Review Board (IRB) for approval of final Regulatory documents and to supply study specific advertising for TV, radio, print and social media in support of patient recruitment and enrollment into the clinical trial. Regularly appeared on local television segments to promote community awareness of new studies. Coordinate community health fairs and outreach programs for underserved area. Assigned to manage and maintained the treatment room used for infusions of chemo and other meds and procedures as directed by the oncologist. Review and assess EMR records and prepare treatments and care plan for private patients. Work with support staff and pharmacist to inventory, maintain storage and timely delivery of sensitive temperature controlled chemo meds.

Clinical Director/Clinical Research Coordinator/Infusion Nurse

Responsibilities included but not limited to the following under the supervision of the Lead Medical Director and Study Protocol as per FDA guidelines

Review the study design of inclusion/exclusion criteria with physician and potential subjects.

Work with the Principal Investigator to identify, screen and enroll eligible subjects according to the protocol requirements.

Responsible for working with the support staff to meet or exceed study enrollment

Ensure the protection of the subjects by verifying informed consent procedures and adheres to protocol requirements/compliance

Ensure that adequate and accurate records are maintained for inspection of sponsor or regulatory agency

Ensured that the integrity of the data submitted on Case Report Forms (CRF) or other relevant data collected is extrapolated from careful source document review and EMR source verification.

Collects, completes and enters data into study specific portal of each CRF or other data capture system

Generated and tracks investigational product accountability and supplies as needed

Track the enrollment of subject activity and progress for reporting to the sponsor.

Scheduled and registered patients into the clinic, review concomitant meds and assess relevant changes, work with pharmacy for refill authorization including controlled substances and schedule home health care or support of home visits

Considerable knowledge of the care and treatment of patients and special procedures that apply to practical nursing in private practice.

Perform patient assessment and record the information in the proper documentation of EMR, flow charts and other nursing tools

Give flu and pneumovax vaccine IM or S-Q as needed, prepare injections for MD, obtain fluid aspiration specimens and process for lab pickup

Prepared pre-chemo drugs, calculate chemo dose, accesses ports, hang chemo, maintains patency of IV line, flush and assess port site, under strict supervision by the house physician who is on site at all times.

Educate and counsel patients concerning their disease, treatment and personal care. Answer their questions after consultation with the provider or as per established procedure in that regard

Assess and review patient during infusion for potential side effects and be aware of any deviation from baseline status. Managed start and stop times of infusion for recording and reporting to physician. Report tolerability progress

Complete lab slips. Reviewed the laboratory reports, EKG finding and relevant assessment of Serious and Non- Serious Adverse Events for physician evaluation

Performed and collected vital signs, EKG, PFT, venipuncture, access ports for serum specimen, started and maintained IV lines for infusion of study medication, provided patient education on diabetic teaching, documented detailed visit procedures and drug dosing

Prepared and maintained bi-monthly payroll timesheets and reports generated with QuickBooks and reported to ADP payroll service.

President/Clinical Director Sun Research Institute

October 1995 to February 2015 San Antonio, Texas 78215

Managed the development of a startup company with knowledge in working for pharmaceutical companies in the placement of outpatient clinical research studies in phase II, III, IV, and device trials and vaccines for immunizations for adult and pediatric use for multi-therapeutic areas. Worked with major pharmaceutical companies in establishing protocols that fit the private practice setting for, Respiratory, Endocrinology, Cardiovascular, Musculoskeletal, Pain Management, Immunology/Hematology, Infectious Disease, and many others. Contracted with independent physicians in their sub-specialty area in support of protocol designed and meet objective of safety and efficacy of study objective. Implemented the required World Wide Assurance and self-identified with FDA for biologic testing. Set-up CLIA laboratory requirement and maintained compliance and proficiency.

Assisted in overseeing the management of approximately 200 clinical trials per year with an average of 20 employees. Budgeted studies and maintained payroll for over 2.5 million revenues. Arranged for the staff continuing medical education requirements, CPR certification, study specific training and support. Designed study specific tools for the streamline of study procedures and maintained subject accountability logs. Supported over 50 sponsor audits and 5 FDA audits without any negative reports or reprimands. Strong HR structure and ability to recognize skilled and talented research staff for delegation of duties. Knowledgeable in H1 visas process and requirements and verification of past employment. Promoted staff and instructed in work ethics in accordance with Texas employment laws and regulations. Instrumental in developing employee handbook and creating a work environment with safety standards for a negative work injury reports. Responsible for writing employee assessments, evaluations, and promoting within the company. Allowing time for enrolling in higher education and maintained industry certifications and requirements.

Worked with CPA and legal department for accurate accounting of payroll, office expenses and other in house cost factors. Resupply of inventory, maintain monthly budget reports and send necessary invoices.

LVN assigned to outpatient service:

University of Texas Health Science Center, San Antonio Texas

May 1993- September 1995

Duties included, patient registration, vital signs, EKG, skin prick allergy testing, PFT, immunotherapy injections, flu and other vaccines, assist physician with suture removal, OB/GYN preparation of specimen, detail documentation in nursing notes, calling in prescriptions, scheduling follow up visit, translation for non-English speaking patients and family.

LVN Unit Floor Nurse, Oncology Service:

Baptist Health System, Downtown San Antonio

May 1983 to May 1994

EDUCATION:

LVN IN GENERAL MEDICINE/CLINICAL RESEARCH STUDIES

ST PHILIPS COLLEGE – SAN ANTOIO TEXAS 1983

Enlisted in the US Army Reserve in May 1984

Rank, Sargent

Honorable Discharged

Dates of service; Active and Reserve status duty from May 1984 – March 23, 1996

ADVANCED COMBAT TRAINING IN GENERAL MEDICINE FOR SUPPORT OF OPERATION DESERT STORM – FIFTH UNITED STATES ARMY

FT. SAM HOUSTON 91ST EVACUATION HOSPITAL - SAN ANTONIO TEXAS 1991

Special Skill, Qualifications, Certificates and Training:

LVN license 1983 –present

Collaborative Institutional Training Initiative, CITI 1998-present

National Institute Health, NIH 1998-present

Good Clinical Practice, GCP 1995-present

International Air Transport Training Association, IATA 1995-present

CPR, Diabetic Educator 2001- present

Maintained individual professional growth and development by meeting requirements for mandatory CME, skills competency, supports department-based goals, which contribute to the success of the organization

Have served as preceptor, mentor and resource to less experience staff

Strong Phlebotomy skills for pediatric and adults

Notary Public officer 2014-present

Advisory Board Member NW Vista College District, Clinical Research Program 2009-present

Languages Spoken:

English

Spanish

Portuguese, limited read and write

References:

Ruben Tenorio, MD, ac3bgo@r.postjobfree.com

Roger Moczgemba, MD, ac3bgo@r.postjobfree.com

Hector Allende, MD, ac3bgo@r.postjobfree.com

Stephen C. Cohen, MD, ac3bgo@r.postjobfree.com

David Crawford, ac3bgo@r.postjobfree.com



Contact this candidate