Manager Assistant Sponsor
Resume:
Lisandra Trejo
Profile
Highly qualified medical research professional skilled in all aspects of clinical trial coordination, protocols, and participant relationships. Experienced in both medical practice and clinical research environments. Demonstrates strong working knowledge of ICH-GCP, company standard operating procedures, regulatory guidelines, protocols, and monitoring guidelines. Communicates effectively with medical personnel, colleagues, and study participants. Consistently performs at peak professionalism, adhering to code of ethics and business standards. Experienced in multiple study areas, including Diabetes, Hypertension, Gastrointestinal, Gynecology, Dermatology, Ophthalmology, Respiratory, Neurologic, Infectious Disease, Autoimmune Disorders, Cardiovascular, Renal, and Psychiatry. Recognized for initiative, organization, time and task management, and problem-solving skills.
Employment History
Regulatory Director & Clinical Research Coordinator at South Florida Research Center, Inc., Miami, Florida
July 2014 — Present
Responsible for conducting clinical trials in adherence to FDA regulations, GCP and ICH guidelines at all times. Assists in pre-study planning including the preparation of critical documents, contacting sub-investigators, discussing and implementing trial logistics, and subject recruitment strategies. Ensure that all protocol required laboratory tests and procedures are performed. Attend protocol-specific meetings and review scientific and medical literature. Perform all clinical trial-related procedures as delegated by the Principal Investigator. Adhere to OSHA guidelines and biomedical procedures. This position reports to the Principal Investigator. Training and guidance will be provided through regular meetings, phone contacts, and travel. Train appropriate back-up to pre-study meetings, including off-site investigator meetings if required. Maintain a copy of all clinical trial-related correspondence. Creates and maintains an organized filing system for each subject’s chart in each study. At the time of initiation, the CRC will have designed the necessary flow sheets, telephone screening forms, ad information sheets for subjects and investigators with the assistance of the Quality Assurance Manager and Principal Investigator. Responsible for conducting subject visits and scheduling based on protocol timelines and investigator's availability. Maintain, regulatory documents of all site Studies which include producing and/or organize all appropriate regulatory documents, make copies of regulatory documents for all appropriate agencies and institutions and/or CRO’s and sponsors when needed, communicate and schedule protocol related meetings, report all AE and SAE events within 48 hours to the appropriate IRB, and file all study regulatory documents for storage, and ensure that all site staff are trained appropriately.
Site Director & Clinical Research Coordinator at Pines Care Research Center, LLC, Pembroke Pines, Florida
May 2013 — June 2014
●Served as the main in-site overseer.
●Oversaw the Site Manager, Manager Assistant, Principal Investigator, Coordinators, and Regulatory Director.
●Worked with the Site Manager, Manager Assistant, Principal Investigator, Coordinators, and Regulatory Director to accomplish site goals.
●Directed development, growth, and operational strategy, as well as managed employees and hiring.
●Trained appropriate back-up staff as needed.
●Developed workflow policies and procedures for assigned trials.
●Developed workflow policies and procedures, prepares manuals and documents related to site operations.
●Developed study budgets and assumed grant management responsibilities.
●Assisted other members by educating, providing resources and consulting on difficult protocols or projects.
●Provided direct supervision to non-exempt staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.).
●Provided direct supervision to non-exempt staff (i.e. hiring/firing, performance evaluations, disciplinary).
●Planned, performed and designed a statistical analysis of findings.
Clinical Research Coordinator at In-Vivo Clinical Research, Inc., Miami, Florida
March 2013 — May 2013
●Assisted the Principal Investigator (PI) in the conduct of the clinical study according to FDA and Sponsor regulations and guidelines and ensures the safety and welfare of the research participants.
●Drafted and/or reviewed template Informed Consent Forms with Clinical Research Office per FDA, ICH, GCP guidelines and Hoag Policy language.
●Performed other duties as assigned.
●Scheduled or assisted in scheduling follow-up visits for enrolled subjects.
●Documented and reported Unanticipated Problems, Adverse Events and Serious Adverse Events according to Clinical Research Office policy, Sponsor, IRB, FDA, ICH-GCP guidelines and specific protocol, to the Investigator, Sponsor, Clinical Research Office administrative staff, and IRB.
●Completed the Case Report Forms for the study accurately and completely. Abstracted data from hospital records and physician charts to complete CRFs.
●Accommodated changes in workload within the department and demonstrated flexibility in accepting work assignments. Performed assignments as directed by Supervisor.
Clinical Research Coordinator at Health Care Rehab & Research Center, Inc., Hialeah, Florida
May 2012 — March 2013
●Assisted the Principal Investigator (PI) in the conduct of the clinical study according to FDA and Sponsor regulations and guidelines and ensured the safety and welfare of the research participants.
●Drafted and/or reviewed template Informed Consent Forms with Clinical Research Office per FDA, ICH, GCP guidelines and Hoag Policy language.
●Performed other duties as assigned.
●Schedule or assisted in scheduling follow-up visits for enrolled subjects.
●Documented and reported Unanticipated Problems, Adverse Events and Serious Adverse Events according to Clinical Research Office policy, Sponsor, IRB, FDA, ICH and GCP guidelines and specific protocol, to the Investigator, Sponsor, Clinical Research Office administrative staff, and IRB.
●Completed the Case Report Forms for the study accurately and completely. Abstracted data from hospital record and physician charts to complete CRFs.
●Accommodated changes in workload within the department and demonstrated flexibility in accepting work assignments. Performed assignments as directed by Supervisor.
Clinical Research Coordinator at AGA Clinical Trials, Inc, Hialeah, Florida
October 2008 — May 2012
●Assisted the Principal Investigator (PI) in the conduct of the clinical study according to FDA and Sponsor regulations and guidelines and ensures the safety and welfare of the research participants.
●Drafted and/or reviewed template Informed Consent Forms with Clinical Research Office per FDA, ICH, GCP guidelines and Hoag Policy language.
●Performed other duties as assigned.
●Scheduled or assisted in scheduling follow-up visits for enrolled subjects.
●Documented and reported Unanticipated Problems, Adverse Events and Serious Adverse Events according to Clinical Research Office policy, Sponsor, IRB, FDA, ICH-GCP guidelines and specific protocol, to the Investigator, Sponsor, Clinical Research Office administrative staff, and IRB.
●Completed the Case Report Forms for the study accurately and completely. Abstracted data from hospital record and physician charts to complete CRFs.
●Accommodated changes in workload within the department and demonstrates flexibility in accepting work assignments. Performed assignments as directed by Supervisor.
Medical Assistant at La Colonia Medical Center, Inc., Hialeah, FL
June 2007 — June 2008
●Taking medical histories
●Explaining treatment procedures to patients
●Preparing patients for examination
●Assisting the physician during exams
●Collecting and preparing laboratory specimens
●Performing basic laboratory tests
●Instructing patients about medication and special diets
●Preparing and administering medications as directed by a physician
●Transmitting prescription refills as directed
●Drawing blood
●Taking electrocardiograms
●Removing sutures and changing dressings
Education
Medical Assistant Technician, Florida Career College, Miami, Florida
June 2007 — June 2008
Details
1067 NW 100th St.
Miami FL, United States
********.*****@***.***
Skills
Competent in Written and Verbal English
MS Office Products (word, excel, power point)
Fast Learner
Adaptable
Flexible
Extreme Attention to Detail
Ability to Travel without Limitations
Strong Knowledge of Medical Terminology
Electronic Medical Records
Documentation & Reporting
Strong Work Ethic
Time Management
Languages
Spanish; Castilian Native speaker
English Native speaker
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