Manager Clinical Project Research Marketing Management/CRA

LETICIA LUCERO-PALMA

**** *********** ****, *** ****, CA 95138

Mobile # - 408-***-****; Home #- 408-***-****

*********@*****.***

Objective

To obtain a challenging and rewarding career in a diverse research environment where my strong work ethic, education, and expertise can be used to help promote the mission and exceed company goals.

Qualifications

In depth therapeutic and protocol knowledge

Good understanding of project management and possess strong problem-solving and leadership skills.

Have a working knowledge of Food and Drug Administration and other regulatory requirements as well.

Have an understanding of finance and budgets

Pro- active in nature with a go-getter attitude

Self-motivated and exercise a high degree of discretion.

Great interpersonal skills and a team player

Exceptional organizational skills, fast learner, and willing to do whatever is needed to succeed Strong ability to meet aggressive goals and pre-defined measurement criteria; Assertive with follow up tasks and able to work well with people to establish and develop business relationships. Proficiency in computer and MS Office

Professional Experience

2012-present

San Jose Valley Research, Inc. San Jose, CA

Clinical Trial Manager per project/ per contract

Managed vendor set-up; managed study product inventory for a specific protocol; reviewed other study documents such as protocols, Investigator’s brochures, and reports. Fairly negotiated agreements and contracts with vendors and other outside resources needed for each clinical trial project. Communicated all relevant and critical issues to management. Participated in the analysis, summary and reporting of clinical data for regulatory or marketing purposes. Monitored activities at clinical study sites to ensure adherence to Good Clinical Practices and SOPs and the study protocol. Reviewed source data and case report forms for accuracy, completeness, and integrity of the data and identifying and resolving ongoing data issues according to the GCP guidelines.

2008-2012

Paspa Pharmaceuticals Pty Ltd - Clinical Trial Manager Australia

Managed both the national and global clinical research projects and their associated teams including schedule and budget for clinical trial execution and ensuring these trials are conducted in accordance with the ICH, GCP guidelines, the Declaration of Helsinki and national regulations. Managed site selection process; coordinated all clinical trial activities while managing the interfaces with Legal, Quality and Manufacturing Department.

2009-2012 Published Protocol at Clinicaltials.gov- Identifier Number- NCT01682200

Medivet Pty Ltd - Principal Investigator Australia

Designed and implemented the clinical protocol for approval. Recruited, screened and enrolled participants in accordance with good clinical practice guidelines. Collected, recorded and maintained complete data files using good clinical practice in accordance to HIPAA policies. Maintained drug accountability, adequate study supplies and equipment. Ensured participants’ compliance to the study protocol, obtain information from the participants regarding changes in medications or adverse effects and immediately reported such events to the Principal Investigators, sponsors and the IRB. Ensured that appropriate resources are available for a project and resolved project conflicts and issues as well.

NOTE: While I was a clinical trial manager at PaspaPharmceuticals, there was no conflict with the Medivet Project since I did both jobs on a part time basis. Actually I did the Medivet project under the contract of PaspaPharmaceuticals Pty Ltd.

2008-2009 Published Protocol at Clinicaltrials.gov-Identifier Number-NCT01684371

Elmore Oil Pty Ltd - Co-Investigator/Coordinator Australia

Planned and managed clinical trials and achieved quality results. Provided leadership in developing study-related documents, which included protocols, investigator files and informed consent forms. Supervised and assessed the performance of clinical team members and train team members on daily clinical operations. In addition, maintained good relations with investigators and sponsors, which included physicians, medical research staff and outside consultants. Served as liaisons between study sponsors, investigative sites and the clinical research organization.

2005-2008

Actistem Pty Ltd- Research Coordinator Australia

Assisted in protocol design and creation; recruited and screened candidate participants for the trial; managed, coordinated and scheduled patients for baseline and follow-up laboratory tests and transplant procedure. Conducted regular meetings with all participants to ensure their compliance to the study. Travelled to different clinical trial sites to ensure that the facilities are within the regulations and guidelines of Good Clinical Practices and study protocols. Served as a clinical spokesperson in several venues such as professional society forums, industry meetings and corporate seminars and workshops.

2003-2005

Institute of Medical Education - Student Services Coordinator – San Jose, CA

Responsible for the well- being of the students in their assigned school programs.

Dealt with the students' ability to communicate with teachers and peers.

Helped new students adjust to a different setting, and made sure each student maintains a positive attitude. Conducted analysis and generated insights on market trends, company performance and competitor’s performance on our offered courses. Solicited community support and utilization through effective marketing and public relations techniques to stimulate and increase image and visibility of the institutions.

Education

Bachelor of Science in Pre-Med Far Eastern University, Manila Philippines

Associate in Arts in Life Sciences Far Eastern University, Manila, Philippines

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