Project Manager Clinical Research
Resume:
Reseda, Ca *****
Cell: 818-***-****
*****.******@*****.***
Patricia Lopez
Background / Objective
SUMMARY OF EXPERIENCE:
An experienced and dedicated Project Manager and Nurse with more than 10 years in clinical trial research. Experienced in managing complex and diverse clinical trials; including First in Human, Ethnic Sensitivity, Dyna-Bridging (serial CSF sampling), Bioequivalence, and Phase II- IV. Therapeutic areas of experience include Pre / Post Surgical Indications, Pain, Opioid Induced Constipation, Schizophrenia, Depression, Anxiety, Alzheimer’s disease, Parkinson’s and Bipolar diseases. I also have considerable expertise as a Sub Investigator and collection of rating testing.
Experience
PROFESSIONAL EXPERIENCE:
Project Manager, Lotus Clinical Research, Pasadena, CA, USA
March 2013- Present
Responsibilities include:
Responsible for the study from the time of the site feasibility, preclinical, study progress through database lock.
Develop full scale project plans; assemble and coordinate project staff; manage project budgets; manage project resource allocation; plan and schedule project timelines; track project deliverables using appropriate tools; provide direction and support to project team.
Contribute to developmental and regulatory discussions; constantly monitor and report on progress of the project to all stakeholders.
Conduct the initial team meeting to review the contract and protocol and develop recruitment strategy, working schedule, staffing and assignments.
Maintain the Investigator Site File and Trial Master File, as required.
Present reports defining project progress, problems and solutions according to contract specifications.; implement and manage.
Project changes and interventions to achieve project outputs; project evaluations and assessment of results.
Provide and serve as primary contact for clients and client's liaison.
Communicate to team members the scope of work, timeline and study goals, technical information and input from clients throughout the study.
Serve as chairperson for the study team, inform team members of any new information or modification of study-related issues which may affect specific responsibilities of team members.
Acted as a liaison between Sponsor, PI, external vendors, and other departments regarding study conduct, recruitment, deviations, adverse events and serious adverse events.
Set up and accommodate client or client representative visits to Unit.
Assist in all functional areas of the study as needed, including input, review and approval of study-related documents.
Overseeing all aspects of action items and ensuring the proper tools are available.
Involvement with CRA, including their timelines, reports, issues and general study progress.
Clinical Research Coordinator II, Lotus Clinical Research, Pasadena, CA, USA
February 2011- March 2013
Responsibilities include:
Is accountable for achieving the final deliverable within the time period specified in the contract with the customer. Responsible for the line management, selection, training, coaching and performance management of the clinical personnel assigned to their team.
Responsible for the study from the time of the site feasibility, preclinical, study progress through database lock.
Assist in protocol development and CRF design.
Perform site visits and monitor collected data.
Works with a wide variety of indications and healthy normal volunteers in an inpatient / outpatient settings. Surgical setting including pre/intra/post surgical trials. Phase I and Phase II-IV including sub investigator responsibilities.
Supervises all protocol procedures, chart preparation, and recording.
Conducts histories, vital signs, ECGs, laboratory tests, collection of blood draws and IV inversions.
Performs and assists MDs in clinical assessments.
Supervises the administering oral and IV study medication (including blinding of drug solutions and preparation of drug delivery systems).
Trains assisting personnel with protocol review and execution.
Supervised study team and all clinical trial protocol procedures, chart preparation, and documentation; responsible for development and implementation of all protocol specific source documentation.
Worked closely with PI, sub-Is and medical team to evaluate and monitor clinical trial study participant progress and adverse events.
Clinical Research Coordinator, Parexel, Glendale, CA,USA
May 2010 – February 2011
Responsibilities include:
.
Responsible for the study from the time of the assigned date, preclinical, study progress through database lock.
Planned, executed, and assured quality of Phase 1 clinical trials in the Early Drug Development Department, with various indications and protocol types (i.e., HNV, Japanese Bridging, Cerebral Spinal Fluid [CSF], Dose Escalation, etc.).
Supervised study team and all clinical trial protocol procedures, chart preparation, and documentation; responsible for the development and implementation of all protocol specific source documentation.
Worked closely with PI, sub-Is and medical team to evaluate and monitor clinical trial study participant progress and adverse events.
Assist in protocol development and CRF design.
Perform site visits and monitor collected data.
Works with a wide variety of indications and healthy normal volunteers in an inpatient / outpatient settings. Including both Phase I and Phase II-IV including sub investigator responsibilities.
Supervises all protocol procedures, chart preparation, and recording.
Completes case report forms.
Conducts histories, vital signs, ECGs, laboratory tests, collection of blood draws and IV inserions.
Performs and assists MDs in clinical assessments.
Supervises the administering oral and IV study medication (including blinding of drug solutions and preparation of drug delivery systems).
Trains assisting personnel with protocol review and execution.
Sr. Laboratory Associate, Parexel, Glendale, CA,USA
January 2010 – May 2010
Responsibilities include:
Works with a wide variety of indications in an inpatient/outpatient settings.
May be directly responsible for managing individuals.
Collection of specimens from blood to CSF.
Oversees laboratory tests, and phlebotomies.
Supervises all protocol lab related procedures, chart preparation, and recording.
Provide team training sessions for all new protocols.
Laboratory Supervisor, Parexel, Glendale, CA,USA
January 2007 - January 2010
Responsibilities include:
Management of the Early Drug Development Department
Laboratories (5 in total).
Assures all equipment is maintained and working with lab staff in keeping accurate records of study samples and supplies.
Coordinates, executes, and assures quality of clinical trials in
the Early Drug Development Department.
Works with a wide variety of indications in an inpatient/outpatient settings.
Responsible for the planning and executing operational aspects of the clinical project. Work closely with individuals and departments internally and externally.
Directly responsible for managing individuals.
Supervises all protocol lab related procedures, chart preparation, and recording.
Oversees laboratory tests, and phlebotomies.
Provide team training sessions for all new protocols.
Assist in the creation, review and/or update of lab COG’s.
Ensure that laboratory manual remains updated to current COG’s.
Clinical Research Coordinator, California Clinical Trials/ Parexel (acquired California Clinical Trials in 2006),
Glendale, CA,USA
September 2005 – January 2010
Responsibilities include:
Responsible for the study from the time of the assigned date, preclinical, study progress through database lock.
Planned, executed, and assured quality of Phase 1 clinical trials in the Early Drug Development Department, with various indications and protocol types (i.e., HNV, Japanese Bridging, Cerebral Spinal Fluid [CSF], Dose Escalation, etc.).
Supervised study team and all clinical trial protocol procedures, chart preparation, and documentation; responsible for the development and implementation of all protocol specific source documentation.
Worked closely with PI, sub-Is and medical team to evaluate and monitor clinical trial study participant progress and adverse events.
Assist in protocol development and CRF design.
Perform site visits and monitor collected data.
Works with a wide variety of indications and healthy normal volunteers in an inpatient / outpatient settings. Including both Phase I and Phase II-IV including sub investigator responsibilities.
Supervises all protocol procedures, chart preparation, and recording.
Completes case report forms.
Conducts histories, vital signs, ECGs, laboratory tests, collection of blood draws and IV inserions.
Performs and assists MDs in clinical assessments.
Supervises the administering oral and IV study medication (including blinding of drug solutions and preparation of drug delivery systems).
Trains assisting personnel with protocol review and execution.
Research Associate, California Clinical Trials, CA, USA
September 2004 – September 2005
Assisted in the conduct of clinical trials in the Early Drug Development Department.
Executed protocol procedures including patient screening, chart preparation, and recorded and completed case report forms.
Conducted histories, vital signs, ECGs, laboratory tests, and performed clinical assessments.
Dispensed medication and monitored subject progress.
Administrative Assistant, California Clinical Trials, CA, USA, April 2004 – September 2004
Responsibilities included:
Provided daily assistance to assigned CRC.
Reviewed patient documents for Case Report Forms.
Conduct prescreen phone interviews with potential subjects.
Assisted in communicating with Spanish speaking patients and paperwork.
Review and transcribed data from source documents to paper or electronic CRFs.
Assured quality and accuracy of CRFs.
Complied with Quality Management department guidelines.
Knowledgeable in Clinical Operational Guidelines and Medical terminology.
Manager, MJF Salon, Sherman Oaks, CA, USA
September 1998 – April 2004
Responsibility included:
Completed operations of salon.
Education
Preferred College of Nursing, Van Nuys, CA, 2009
California Phlebotomy License, University of California, Los Angeles, Westwood, CA, 2004
High School, Van Nuys High School, Van Nuys, CA, General Studies, 1994
Publications
2007 American Society for Clinical Pharmacology and Therapeutics - acknowledgement
~ Pharmacokinetics and Pharmacodynamics of a Novel Daily of Rivastigmine Transdermal Patch Compared with Twice-daily Capsules in Alzheimer's Diseased Patients.
Language Skills
English: fluent; Spanish: fluent
Professional Associations
Living Vocational Nurse License
Certified Clinical Research Coordinator, ACRP
National Certified Phlebotomy Technician
Society of Clinical Research Associates, Member
BLS Certified
References
Isaac Caudillo, Project Manager, Giliad Int. (formally with Amgen)
Beatriz Falcon, Project Manager, Parexel Int.
Chris Liu, M.D. Principal Investigator, Lotus Clinical Research
*Additional information available upon request*
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