Melany May Dalida

Melany May M. Dalida, RN

2281 Flerida Street, Pandacan,

Manila City, Philippines

Contact No. +63 917 680 8094

Email add: [email protected]
Personal Statement

Working as a clinical research associate for more than 5 years, I have gained experiences that highly contributed to my expertise on the clinical trial field. These experiences did not just taught me to be a better site monitor but they also improved my skills in interacting with all research stakeholders in a professional manner, and heightened my passion in working with industries to provide better options for healthcare.

Possessing prior knowledge on medical science thru my nursing education, clinical and community nursing research, and clinical research trials, I am currently looking for a position with a reputable organization.

Key Strengths:

· A sharp analytical mind able to think laterally and see the big picture.

· Enthusiastic and positive with the ability to be diplomatic and tactful.

· Passionate in working in an industry that seeks to provide better health outcomes.

· Strong communication and presentation – able to build relationships on all levels.

· A supportive team member – with initiative to seek extra responsibilities to achieve team goals and the ability to work unsupervised.

· A natural leader who is a willing teacher and mentor.

· Observant with excellent attention to detail.

· Able to make decisions and solve problems within corporate guidelines.

· High organised – able to juggle multiple tasks and responsibilities.

· Over-all a multi-skilled achiever suitable to challenging areas of responsibility.

· Highly trained on ICH/GCP guidelines and knowledge on drug development.

· Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word

· Client focused approach to work, ability to interact professionally within a client organization

EDUCATION

Bachelor of Science in Nursing University of the Philippines Manila, 2002 – 2007

Registered Nurse, Nurse Licensure Exam, June 2007

Summary

Over 5 years of experience working in clinical research as a Clinical Research Associate.

Phase IV Trial Experience: Flu
Phase III Trial Experience: Flu (Pediatrics), Meningococcal (Pediatrics), Meningococcal (Adults), Cardiovascular (DVT), Cardiovascular (MI), Asthma, Gastrointestinal, Oncology
Phase II Trial Experience: Typhoid, Dengue
Phase I Trial Experience: Chronic Hepatitis B, Device

WORK EXPERIENCE

January 2015 to Present

Clinical Research Associate II

Quintiles Philippines, Inc.

Pasig City, Philippines

Job Description

· Mentoring of new Clinical Research Associates (1-2)

· Act as the main line of communication between the sponsor and the investigator

· Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout

· Responsible for the safety and proper conduct throughout the trial

· Verifying that the investigator follows the approved protocol and all GCP procedures

· Verifying that source data/documents and other trial records are accurate, complete, and maintained

· Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs

· Conduct co-monitoring activities with new employees

Projects handled:

1. Monitoring and site management of 6 sites in the Philippines with around 100 subjects for a Phase III oncology trial

2. Monitoring and site management of 2 sites in the Philippines with around 80 subjects for a Phase III cardiovascular study

3. Site initiation of 2 sites in the Philippines with target of 10 subjects for a Phase I infectious disease trial (Chronic Hepatitis B – involved both device and IP, first in human)

4. Site initiation of 1 site in the Philippines with target of 20 subjects for a Phase III gastrointestinal study

5. Monitoring and site management of 1 site in the Philippines with 330 subjects for a Phase II Dengue study

6. Site selection of 6 sites in the Philippines for a Phase III asthma trial

7. Site selection and SIV of 1 site in the Philippines for a Dengue epidemiological study

March 2014 to December 2014

Clinical Research Associate II

Covance Philippines

Makati City, Philippines

Job Description:

· Responsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards;

· Responsible for independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory / sponsor requirements – within specific timelines and quality standards;

· Work with sites to finalize Site Specific Informed Consent Forms in accordance with Covance, site and sponsor specifications.

· Accountable for the collation and verification of the submission documentation in assigned countries; accountable for the dispatch and tracking of submissions to CA, ECs and other bodies as appropriate in assigned countries.

· Review and negotiate Investigator contracts and budgets. Use sponsor approved fallback language and budget parameters appropriately.

· Maintain communication with Investigative sites, Sponsors and internal personnel regarding status of contract and contract-related documents.

· Perform feasibility studies

Projects handled:

1. Lead CRA for a Phase III Global Influenza Vaccine Study (Total of 6 Sites with 200-400 subjects each)

2. Monitoring and site management of 1 site in the Philippines with 600 subjects for a Phase III Global Influenza Vaccine Study

3. Monitoring and Site management of 1 site in the Philippines for a Phase III DVT Study
June 2013 to February 2014

Clinical Research Associate II

Parexel International

Makati, City

Job Description:

· Implements and monitor assigned trials

· Ensures that study activities in each study site are in line with the timelines set by the international/regional study team

· Monitors and coordinates clinical studies as part of Novartis global vaccines operations, respecting ICH-GCP guidelines, local regulatory requirements and specific Novartis SOP

· Ensures that clinical trial data are accurate and valid for further statistical evaluation and clinical report

· Involved in study set-up activities in the country including study budget planning and investigator site selection

· In-charge of Investigator site set-up, initiation and site closure activities

· Provides Good Clinical Practice, protocol-specific and other relevant training to Investigator study teams

· Responsible for safety and pharmacovigilance reporting to Central Safety, investigators and regulatory authorities

· Accountable for the shipment and proper handling of investigational product, clinical trial supplies and biological specimen

· Initiates and conducts Local/ Regional Investigator(s) and Monitor(s) Meetings

Projects handled:

1. Lead CRA in the Philippines of a Phase III Meningococcal Vaccine Study

2. Start-Up, monitoring and site management of 2 site in the Philippines with 450 subjects for a Phase III Meningococcal Vaccine Study in Pediatrics

3. Start-Up, monitoring and site management of 1 site in the Philippines with 150 subjects for a Phase III Meningococcal Vaccine Study in adults o Monitoring of 2 sites in Philippines with 400 subjects for an HPV Study in adults

October 2010 to June 2013

Clinical Research Associate

Novartis Healthcare Philippines