a seasoned Physician assistant and study Coordinator skilled in the implementation of Phase I through iii Clinical trials. the broad scope of my clinical experience as well as my previous academic affiliations have allowed me to work alongside global talent at the forefront of their respective fields.
Clinical Research Coordinator
Since January 2016
i have experience in Rheumatology, Cardiology endocrine and pulmonology. i liaise with sponsors, vendors and work closely with the pi to insure the smooth implementation of study procedures and collection of clean data. ever mindful of Patient Safety, i manage the myriad considerations and ever-changing priorities in accordance with the tenets of gcp. strategic and organized SOP's foster success in these highly- regulated environs my experience in clinical practice, make me an invaluable resource to the pi and i enjoy a very hands-on role. i am proactive, intuitive and self-directed. i am well-versed and cognizant of community standards of care, the tenets of gcp, and ich, am able to smoothly navigate the landscape of new Drug Development. my background in Medical writing has proven an invaluable asset as i am often the primary point of contact for patients and sponsors, alike. this skill set is helpful in communicating with irb's, with monitors and with the creation of study-specific source documents. the studies i manage have moved from simple studies of a handful of end-points, to complex Rheumatology and oncology studies with upwards of 20 primary endpoints and 50 secondary endpoints, 5 arms with complex medical histories. it is rare that one finds a study Coordinator or any Research professional with the level of clinical sophistication i have developed. with respect to future Career aspirations, i am seeking a managerial or clinical role within the Pharmaceutical sector as a msl or Clinical Trial educator or pm. I have experience in Rheumatology, Cardiology Endocrine and Pulmonology. I liaise with sponsors, vendors and work closely with the PI to insure the smooth implementation of study procedures and collection of clean data. Ever mindful of patient safety, I manage the myriad considerations and ever-changing priorities in accordance with the tenets of GCP. Strategic and organized SOP's foster success in these highly- regulated environs My experience in clinical practice, make me an invaluable resource to the PI and I enjoy a very hands-on role. I am proactive, intuitive and self-directed. I am well-versed and cognizant of community standards of care, the tenets of GCP, and ICH, am able to smoothly navigate the landscape of new drug development. My background in medical writing has proven an invaluable asset as I am often the primary point of contact for patients and sponsors, alike. This skill set is helpful in communicating with IRB's, with monitors and with the creation of study-specific source documents. The studies I manage have moved from simple studies of a handful of end-points, to complex Rheumatology and Oncology studies with upwards of 20 primary endpoints and 50 secondary endpoints, 5 arms with complex medical histories. It is rare that one finds a study coordinator or any research professional with the level of clinical sophistication I have developed. With respect to future career aspirations, I am seeking a managerial or clinical role within the pharmaceutical sector as a MSL or Clinical Trial Educator or PM.
Medical Content Writer
Since February 2012
work as a Medical Writer with a focus towards educational, Marketing or regulatory materials for use in Medical Device and pharma contracts. i formulate educational content for medical Sales force Training as well as patient Education materials.i also assist in the preparation of regulatory documents such as those involved in ind submissions, the investigators brochure and Training manuals for site staff and study specific documents to enhance adherence and maintain the integrity of the study science)" rel="nofollow">Protocol. Work as a medical writer with a focus towards educational, marketing or regulatory materials for use in medical device and pharma contracts. I formulate educational content for medical sales force training as well as patient education materials.I also assist in the preparation of regulatory documents such as those involved in IND submissions, the Investigators Brochure and training manuals for site staff and study specific documents to enhance adherence and maintain the integrity of the study protocol.
Clinical Trial LiasionJanuary 2017 --- December 2017
i am a seasoned Physician assistant with a strong background in Rheumatology, Hematology, oncology and Cardiology as well as the surgical subspecialty of cardiothoracic Surgery. the lions share of my 20 year Career in Medicine has been spent as a clinician. however, i have always chosen to work at academic institutions, where being at the patient’s bedside, involved a significant educational component, and allowed me to fulfill my love of Education. the last several years have been devoted to Clinical research, where i see my contribution to the arena of new Drug Development and am seeking a position within the biotech or pharma industry. within the industry i see my passion for improving the lives of patients with exciting novel therapies come to life. the tremendous strides made in the Lab, bring this knowledge full circle, from bench work to bedside. i am an enthusiastic and passionate educator and have been fortunate to work with an amazing pool of talent, some of the best and brightest in Medicine, who still have a profound influence on all that i do, and whose legacy i strive to pass along with dynamic and engaging methods, solutions and strategies to promote the best in clinical Medicine or research.
Physician AssistantFebruary 2008 --- June 2011
as a Physician assistant, i worked within a multi-Physician practice providing urgent care services such as physical exams, fractures including interpretation of radiographs, casting and splinting of fractures, wound management in the repair of simple to complex lacerations with excellent cosmesis on par with a plastics provider. diagnosis and management of all the usual entities seen in a uc/ed environment such as uri, sob,pna, dka, mi, chf, sepsis, acute abdomen, ugib and all acuity levels.and all ages , peds to adult.
Physician AssistantJanuary 2007 --- February 2008
i worked on the cardiothoracic Surgery service, i was principally responsible for chest tube placement, femoral arterial line placement svg harvesting and wound closure ( sternal and leg). i managed all aspects of patient care. in the sicu as well as wards with duties such as post-op infections, chf and mi management. in the outpatient setting, i followed clinic patients with CAD post-op or in preparation for bypass or valve Surgery. i also did new consultations for lung ca patients (non-small Cell ) and emergent ct placement.
Physician AssistantFebruary 2003 --- January 2007
as a senior pa, i managed all patient acuity levels with the major and minor trauma units. i worked almost autonomously, with little supervision in an urban ed seeing some 50,000 patients annually. great exposure to trauma as well as those with acs, cva, ugib, dka, sepsis, organ failure and surgical emergencies. this position was also heavy on ortho trauma due to the fact that there was no residency program. the position called for a pa confident in their ability and capable of managing even the sickest patients relatively autonomously. i am also Expert in procedures such as complex laceration repairs, lumbar puncture, i & d, chest tube placement, central line placement and airway management. the years spent in cvts have also trained me to become proficient in the interpretation of cxr's, and ekg's. i am excellent in the identification and management of fractures, both surgical and non-surgical, as well as complications such as compartment syndrome. the ed at wmmc was an 80/20 mix of adult/peds and am equally comfortable with both populations.
Physician AssistantJanuary 2001 --- February 2003
direct patient care responsibilities in very busy oncology/Hematology practice. managed daily infusion clinic, inpatient wards, and icu, as well as the outpatient clinic and new consultations. began induction chemotherapy for all solid and hematologic malignancies. managed all toxicities and complications such as line sepsis, neutropenia, cytopenias, tumor lysis syndrome , paraneoplastic syndromes , hyperviscosity syndromes ,pneumonia.
Senior Physician Assistant and Clinical InstructorAugust 1997 --- March 2001
worked both on both the surgical service in cardiothoracic Surgery division and the medical service in primary care managing my panel of one thousand patients using evidence-based medical practice. taught pa students during their inpatient Internal medicine clerkship.
B.S Physician Assistant Practice in Physician Assistant from Keck School of Medicine of the University of Southern California in 1997
Master of Arts (M.A.) in Psychology from Pepperdine University Graduate School of Education and Psychology in 1995
Bachelor of Arts (B.A.) in Psychology, Pre-PA/Medical Studies from California State University-Northridge in 1990
Training and Certification
Advanced Cardiac Life Support in 0000 Certification
EDC: various platforms Inform 6.0 Medidata Rave in 0000 Certification
Good Clinical Practices and International Consortium on Harmonization in 0000 Certification
Inform 6.0 in 0000 Certification
International Air Transportation Authority (IATA) in 0000 Certification
IVRS/ IWRS, various platforms in 0000 Certification
Medidata Rave in 0000 Certification
PANRE, 2003 top 10% nationally. in 0000 Certification