Clinical Research Physician
Since June 2013
Freelance Clinical Research Physician for PROCALVIE having responsibilities and duties as follows: I oversee safety issues of projects conducted for various sponsors, which include the following: adverse event reporting to the sponsor, follow up of adverse events as necessary, communication of safety issues to the head of the department or designee, participate in the on-call system for providing 24/7 medical support, provide all necessary medical support functions as defined by project specific contractual obligations which include the following: medical information source, ongoing training for project teams in therapeutic areas as requested, review of study documentation (protocol, CRF. etc.), contribute to investigator meeting presentations, ongoing safety review of individual patient laboratory reports generated by central laboratories, CRF safety review, I contribute any necessary medical input into integrated clinical and statistical reports, assist in making presentations to potential clients when appropriate, demonstrate a thorough understanding of Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs, demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations, keep the person to whom I’m reporting informed of any issues within the department which require attention, line management of DSAs as appropriate.
MD - medical doctor
Since November 2000
Medical Doctor as general practitioner and palliative care specialist for PRO MEDICAL Care. Job function: To assess chronic neurological patients at their homes. Medical care is provided through visits made by nurses and doctors, who made clinical examinations, diagnose, dose and treatment indication and care. Job Duties: The following medical maneuvers are performed: - evaluation and evolution monitoring, measuring of physiological parameters: blood pressure, hart rate, breathing, temperature, diuresis; - drugs administration: injection (im, iv, drips, sc), oral, ointments, aerosols; - lab samples, probes, cleansing, enemas, urinary probe, wound care and deep bedsore care; - stoma, fistula and tubs drain care; blood sugar measurements; - pleural and peritoneal taps, gastric probe feeding; - palliative care; - medical education for patients and family carriers; - Medical Data collecting for clinical trials and medical scientifically statistical activities. The ProMedical Care Clinic provides medical assistance for a population of around 17,500 people.
Clinical Research Physician
May 2012 --- December 2012
Research Physician for Phase I-II Clinical Trials for PRA International. Job Function: I applied my medical knowledge and expertise in assessing potential subjects for participation in clinical research trials. Participate as a member of medical investigator team and worked collaboratively with other team members in order to preserve and protect research subject safety. Job Duties: I used my existing knowledge of protocols, medical examination and laboratory diagnostic techniques to prepare planning for screening of subjects for inclusion in studies. I performed specific, routine analysis of physical examination findings, laboratory results, ECG interpretation, and whether or not subject meets Inclusion/Exclusion criteria. I informed Medical Director immediately of patient safety issues, communicating concerns or issues to study sponsors. I counseled subjects with regard to abnormal and or exclusionary diagnostic results, as necessary. I accurately completed source documents and e-CRF data input. I provided medical care and emergency care for study subjects, as necessary. To demonstrate up-to-date, accurate, working knowledge of Company's Standard Operating Procedures, Work Instructions and details of study-specific protocols to ensure regulatory compliance. I executed my duties responsibly and ethically to ensure ethical conduct of clinical research trials. I contributed to a constructive and collaborative culture within company medical team and interactions with other personnel. Work was on self-employment contract.
Medical Practitioner, CCD
September 2008 --- November 2011
Acquire information on the specific disease market, competitors, and available treatment options; develop a business plan, propose targets and timelines; permanent contact by regular visits to Healthcare professionals involved in diagnosis and treatment of specific disease; lobbying to Key opinion leaders, authorities in order to achieve the best market access for product – price & reimbursement, collaboration with Health Economics Specialist; disseminate the latest information on product to healthcare professionals by screening the literature; collaboration with logistics department in the production planning for the product; monitor the supply chain for the product including stock level in different sites; initiate and coordinate the training and activities of the drug specialized nurses; monitor the activities of the drug specialized nurses; report periodically activity and progress of the product.
August 2006 --- September 2008
CardinalHealth Ltd USA and GENERAL ELECTRIC USA Ultrasound and Lunar. Applications trainer for PYXIS – holistic dispensing systems for hospitals, ultrasound - US and Dual X-ray Absorbtiometry - DXA applications at user sites. Business managed as a hole, separate from the rest of the company. Member as expert and auditor in audit teams for companies that requested ISO 9001 certificates.
March 2006 --- August 2006
- Clinical Monitor in clinical trials for imuno-suppresors drugs used as medication along with solid organ transplants for ASTELLAS PHARMA Inc. Tokyo, Japan. Studies stopped for delays related with preparing investigators site.
January 2004 --- March 2006
- Marketing Consultant at TARUS&TARUS PARTNERS GmbH, Vienna, Austria, importer and distributor on the Romanian Pharmaceutical Market having attributes to develop and implement the marketing strategies for all brands in portfolio, analyze the market and planning, provide support to sales force, estimations and budgeting for promoting brands, establish marketing materials needs for sales force/brands/quarter, medical support and representation in relation with opinion leaders, quarterly analyses of the marketing plans implementation and competitors activities, congress participation, theoretical and scientifically support through a organized training plans for sales force and recruitment activities.
January 1996 --- September 2003
I did follow many Clinical Trials; this was done along with clinicians from hospital, so that I could implement the theoretical knowledge into practice and delegate responsibilities. Started as Professional sales representative at SCHERING-PLOUGH Central East promoting: antibiotics, corticosteroids, allergy drugs and oncology drugs. All this time the territory management was a permanent challenge because my area changed permanently, my tasks changed with the permanently new drugs introduced by the company and of course of the new clients on the market. The targeted clients were very divers and acting in different levels of the medical field so that was another challenge making sure that everything is promoted and all the information its reaches the recipient in the proper way and quantity.
Palliative Medicine Specialist & Medical Manager
October 1993 --- January 1996
Hospice Manager and Palliative Medicine Specialist at HOSPICE “House of Hope”. Job Function: Acting as Medical Doctor and team leader for a multidisciplinary team consisting of 15 team members: 6 nurses, 2 occupational therapists, 1 priest, 4 volunteers, 1 social worker, and 1 administrator. Job Duties: I was Medical Doctor for HOSPICE “House of Hope”, first Romania’s Hospice, caring for patients in terminal conditions at home. Responsive for medical assessment, examination and medical interventions for providing symptom evaluation, diagnose and improvement of symptoms. This were performed as a integrate system of home visits to the patients, as Medical Input. I acted as Chair Person in management meetings consisting in a Tripartite Board together with Chef Nurse and Chef Accountant, as Management Input. Another component of my activity was acting as liaison person with authorities in Romania like: National Health Ministry representatives, Mass Media, other ONG and Pharmacists. Overall intention was for trying to make this new doctrine better known, as PR Input.
September 1992 --- October 1994
-Professor Assistant for Anatomy Department of Medicine Faculty, “Transilvania” University and College of Nurses in Brasov. Teaching disciplines were Internal Medicine and History of Nursing Profession. Preparing the courses and seminars for students and also conducting the Diploma examinations for final graduating examinations.
January 1993 --- October 1993
Working as GP in a rural practice in Brasov County providing medical assistance for a population of around 3,500 population. Medical examination of general population, adults, children between 0-16 years old, elderly chronic pathology and medical care.
November 1991 --- May 1993
Medical Doctor in Brasov County Hospital. Working as house officer at Surgery Unit of the County Hospital. Participating as second surgeon in the Theatre for general abdominal surgery (gastric, enteric and gynecology surgery, surgery of the veins of the inferior limbs).
Palliative Consultant in Paliative Medicine from Cardiff University / Prifysgol Caerdydd in 1996
Medical Bachelor in Medicine from Universitatea de Medicină și Farmacie din Târgu-Mureș in 1991