Rowena P. Obedencio

**** ****** *****, *** ****, CA 95118

Cell: 831-***-****

Email: adnx2z@r.postjobfree.com

QUALIFICATIONS:

I have been with the clinical operations team as a Clinical Trial Assistant for over 5 years. I am currently supporting 3 studies . I am working closely with the teams on ensuring the electronic Trial Master File is complete and accurate and am continuing to add to my responsibilities with limited CRA duties.

I also have over four years of experience in a hemodialysis clinic working with medical teams (Medical doctors and nurses). Under the management of a nurse, I administered medications to patients. I assisted in conducting research studies and filed patient study documents. I am proficient in medical terminology. I possess strong organizational skills, detail-oriented, consistently meeting deadlines and able to prioritize multiple tasks. I played a key role with Trial Interactive system build for study specific eTMF system with Relypsa. Continuously providing project specific support related to the conduct of the clinical trials.

I am organized, detail-oriented, conscious of deadlines, and PROFESSIONAL EXPERIENCE

ProTrials Research Inc.: San Jose, CA 2020 - Present Sr. Clinical Trials Associate

● Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.).

● Sets-up and maintains the Trial Master File (TMF) using Veeva system.

● Maintains and disseminates basic study tracking information including, but not limited to: Visit reports, regulatory documents, site contact lists, team contact lists, vendor lists, and budget disbursements.

● Manages and tracks study-related supplies including Investigational Product; receives and prepares requests, ships and returns study-related supplies including Investigational Product supplies. Assists in preparing materials for investigator meetings, and study manuals.

● Takes meeting minutes and provides draft to the appropriate study personnel (e.g., PMs, LCRA) for review and approval.

● Communicates effectively with members of the ProTrials project teams, interfacing directly with sponsor as directed by Project Manager (PM), in a collaborative manner.

● Preparing site payments quarterly for PM review. Once approved, I work closely with the finance team to ensure payments have been processed. Relypsa, Inc.: Redwood City, CA 2016 - 2020 Sr. Clinical Trial Assistant – Permanent

(2018 – 2020)

● Clinical Trial Assistant – Contractor (2016 – 2018)

● Managed the eTMF.

● Provided support and worked closely with the vendors and internal team for eTMF submissions. Organized and prepared files related to study tracking, reporting and submitted to sponsor(s) TMF within established guidelines.

● Participated in the organization and execution of any related meetings.

● Organized and maintained tracking system tools and processes to increase Rowena P. Obedencio

5060 Hawley Court, San Jose, CA 95118

Cell: 831-***-****

Email: adnx2z@r.postjobfree.com

efficiencies of the clinical trial.

● Assisted in the tracking and distribution of reports.

● Participated in study startup including review and development of study related documents: Site regulatory packages, study manuals, instructions, etc.

● Prepared administrative logs or reports in order to track site data and documents.

● Set-up, filed and maintained clinical trial files and tracking tools.

● Interacted and communicated with CRO to ensure Trial Master File (TMF) is complete and accurate. Developed and maintained tracking tools to support the study.

● Set-up and organized meetings (ie: with Study Management Team (SMT) or CRO or vendors).

● Recorded meeting minutes during meetings with CSPs.

● Prepared documents for mass mailings.

● Worked very closely with the Clinical Operations team and other departments for any administrative support and to achieve tasks on hand.

● Complied with departmental SOPs and GCP/ICH.

● Phone calls and meetings from CRO and vendors to address issues in a timely manner.

Satellite Dialysis: San Jose, CA 2011 - 2016 Certified Clinical Hemodialysis Technician

● Performed and monitored hemodialysis treatment according to the center’s policies and procedures. Cannulated patients for dialysis treatments, initiated treatments, monitored patients and machines, terminates treatments.

● Performed thorough data collection and documentation for every patient.

● Communicated information such as patient assessment to the medical team members. Administered medications such heparin, and lidocaine per doctor’s orders under the direction and supervision of a Registered Nurse.

● Obtained blood samples and culture specimens as ordered and performed routine lab tests such glucose levels, transonic reading, etc.

● Provided reinforcement and education to patients and caregivers to increase understanding of treatment and control of kidney disease. Monterey Credit Union: Monterey, CA 2003 - 2006 ATM Coordinator; Sharedraft Coordinator

● Provided service in regards with their ATMs and Sharedraft problems

● Reviewed daily ACH and check posting exception report; researched member accounts and take appropriate action based on established procedures.

● Reviewed overdrawn account report and follow established procedures for necessary actions. Posted NSF charge-offs following the established procedure. Tracked and prepared charge-off report account for recoveries.

● Processed Federal Reserve Bank returned item cash letters.

● Processed ACH exceptions and returned checks. Set up and maintained ACH originations, stop payments, and revocations.

● Served as back-up for other positions in the department. Rowena P. Obedencio

5060 Hawley Court, San Jose, CA 95118

Cell: 831-***-****

Email: adnx2z@r.postjobfree.com

Community Bank of Central California: Marina, CA 2001 - 2003 Customer Service Manager

● Ensured high level of customer service.

● Supported and assisted staff with processing transactions and resolution of errors and customer disputes.

● Employment training: products, cross-sell, referrals etc.

● Conducted meetings and training sessions with staff

● Monitored teller transactions to ensure adherence to cash and authorization limits COMPUTER SKILLS: Proficiency in Microsoft Office, Word, Outlook and Powerpoint. EDUCATION AND CERTIFICATION

UCSC Extension, San Jose, CA Oct.-Dec. 2018

Good Clinical Practices (GCP) Course

San Jose State University, San Jose, CA 1994-1998

BS Business Management

Hemodialysis Training School, Union City Mar. 2010-Jun. 2010 Certified Hemodialysis Technician

● Certified Patient Care Technician

● 80 hours of theory, including physiology and pathology of renal failure, dialysis devices. Vascular access, procedures and complications, reprocessing and water treatment

● 246 hours of clinical training, including on-site training at DaVita, Union City

● Working knowledge of Fresenius H and K machines

● Maintained a sterile work environment to help with infection control

● Learned and practiced cannulation techniques

● Assessed patient prior and after treatment, including access site, weight, vital signs, comfort level and other patient concerns

● Administered medications under charge nurse supervision

● Educated in AAMI, OSHA, CMS, and FDA guidelines

Medical Research Management, San Diego, CA June 2014 Fundamentals of Clinical Research GCP, Medical/Clinical Terminology, Trial Master File

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