TAO LERE

HOUSTON TX, USA ***** 832-***-**** ad2olq@r.postjobfree.com

PROFESSIONAL SUMMARY

Analytical Clinical Research Associate with a minimum of 8 years’ experience working in a CRO. Having horned skills in project development, screening documents, and reporting clinical study progress. Ability to coordinate and facilitate research activities and submit protocols for regulatory approval. With impeccable people skills that serve as a resourceful point-of-contact quality during coordination of project teams for effective results.

THERAPEUTIC EXPERIENCE

Oncology/Hematology- Breast Cancer (Phase II), Ovarian Cancer (Phase 1), Pancreatic Cancer (Phase II), B-Cell Lymphoma (Phase 1), Bladder Cancer (Phase III), Melanoma (Phase 1), Head and Neck Cancer (Phase 1)

Medical Device- Ventilator, Vein- Viewer Vision, Glucometer, IUD, Pacemaker

Cardiovascular- Myocardial Infarction (Phase III), Hypertension (Phase III)

Respiratory- Asthma (Phase I/II), Pneumonia (Phase I)

SKILLS

Electronic Data Capture: Medidata Rave, eClinical, Oracle, Medrio, Clinflash

Clinical Trial Management System: Cascade, Clinflash, Florence,

IVRS: Clinphone, Impala, Medidata RTSM, Vestigo

TMF: Homegrown Electronic Trial Master File, Clinflash, Veeva Vault

Microsoft Office: Word, PowerPoint, Excel

Proficient in electronic patient systems and electronic data capture

team oriented, strong organizational skills with attention to detail

Clear, concise, and effective written and verbal communication skills.

WORK HISTORY

SENIOR CLINICAL RESEARCH ASSOCIATE I 10/2022 to Present

TIGERMED

Understands/manages/satisfies sponsor contractual, organizational and relationship needs/expectations.

Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plans to the sponsors.

Leads and directs internal cross-functional team members and third parties/vendors.

Guides and supports team members in identifying and analyzing risks, prioritizing, troubleshooting and contingency planning.

Participates in site selections, initiations, monitoring/co-monitoring, and closeout activities.

Ensures adherence to company SOP, policies, and guidelines at the project level.

SENIOR CLINICAL RESEARCH ASSOCIATE 09/2020 to 10/2022

PPD

Monitor and manage Phase I, II, III and IV clinical trials.

Respond to site issues identified during monitoring visits (i.e., non-responsive site, Protocol Deviations concerns, and quality issues.).

Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.

Maintenance of regulatory binders.

Perform documentation and monitoring of all clinical research trial data.

Conduct protocol training to staff at investigator site(s) during site initiation visit, to ensure that site(s) is/are equipped to conduct the clinical study. Ensure that any serious protocol or site issues were immediately raised to the attention of project management, clinical team management and clinical operations management by phone or in writing as the degree of seriousness dictates.

Perform drug accountability.

Perform site visits which includes - site qualification, initiation, monitoring, and close-out visits.

Track Serious Adverse Events at assigned sites and ensured timely reporting to the sponsor and IRB.

Communicate with study sites to ensure that all clinical aspects of the trial are adhered to in accordance with the protocol and Sponsor directives as well as state and federal regulations, guidelines and/or policies; provide on-going instruction to research site personnel, as necessary, on proper conduct of the trial.

Review protocol violations with investigators and implement corrective actions to ensure future compliance the protocol and applicable regulations (FDA/GCP/ICH/IRB).

Receive, reviews, and tracks regulatory documents required for the study site activation and maintenance (FDA 1572, Investigator CVs, Financial Disclosures, IRB approvals, Informed Consent, credential checks, lab reference ranges, protocol signatures, Investigator Brochure, etc.

Ensure proper essential documents are in place prior to trial start-up and on an ongoing basis throughout the study as part of the continuous file audit review process.

Clearly document all observations in reports and letters in a timely manner, according to accepted business writing standards.

CLINICAL RESEARCH ASSOCIATE II 07/2017 to 09/2020

JACOBIO PHARMACEUTICALS

Ensured ICH/GCP local regulatory requirements were observed.

Participated and assisted in all types of site visits.

Maintained timely and effective communication among team members and site staff.

Monitored Pre-Study Site Visits (PSSV) of clinical trials.

Performed source document verification (SDV) according to contractual requirements.

Regularly performed Investigational Product (IP) accountability.

Ensured timely reporting of Adverse Event (AE)/ Serious Adverse Event (SAE) and Protocol Violations.

Responsible for all aspects of site management from collaboration on site selection to study closeout.

Ensured compliance with all protocol requirements.

Ensured timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP).

Completed and submitted visit trip reports according to SOP requirements.

Documented and tracked the resolution of all outstanding site-specific protocol-related issues.

Ensured that effective patient identification and recruitment plan were in place.

Developed corrective and preventative actions with PI and site personnel to close all open issues.

Ensured patient safety was maintained and all safety issues were reported correctly according to all relevant local and international regulatory requirements.

Independently coordinates and performs activities associated with the evaluation, initiation, monitoring, and close-out of Clinical trials.

CLINICAL RESEARCH ASSOCIATE 08/2015 to 07/2017

SYNEOS

Monitored Pre-study site visits (PSSV) of clinical trials.

Participated in assisting Clinical Research Associates (CRA) in all types of site visits.

Conducted presentations and trained site personnel during Investigator Meetings.

Visited sites to perform ongoing site monitoring visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication.

Assured compliance with all protocol requirements.

Training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists as required during the study.

Monitored drug inventory, dispensing, compliance, and return.

Tracked and reported site enrollment, progress, and adverse events.

Ensured that regulatory documents are complete and in compliance with federal and internal guidelines.

Assured Investigator and site adherence to timelines and set study targets.

Responded to requests from investigative sites in a timely fashion.

Served as a resource for and interact with other functional areas to resolve site issues and facilitate the meeting of project timelines.

Conducted site closeout visits and tasks including test article reconciliation and disposition, review of accuracy and completeness of study files, and retrieval of all outstanding documents.

Gathered and maintained documentation for site specific files in accordance with FDA regulations and company SOP's.

Prepared and submitted trip reports, expense reports, and timesheets.

RESEARCH STUDY COORDINATOR 04/2013 to 08/2015

Nacogdoches Medical Centre

Initiated care plan and maintaining patient database to ensure up to date information.

Developed assignments to ensure accurate and efficient client care.

Scheduled staff for optimal patient coverage and care depending on client and staff needs and conduct initial client care giver meetings.

Screened patients for enrollment into clinical trials.

Managed investigational trials under PI supervision.

Acted as a liaison between sponsor and PI.

Maintained research data, patient files, and study database.

Followed up on research subjects per study protocol.

Submitted all Institutional Review Board (IRB) documentation.

Prepared documents and study binders for FDA audits as needed.

On call every other weekend to ensure emergencies are taken care of.

Provided comprehensive case management.

Completed and submitted payroll according to staff schedule.

Oriented and educated clients and their families on care giving roles and procedures.

Ensured patient rights are protected and respected.

Recognized and modified care plans to support client ongoing needs.

Performed on demand client care if care givers are unavailable.

Represented the company in a professional manner at all times.

EDUCATION

Bachelor of Science: Biology

LASU

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