Clinical Research Data

Alaba Obaro

**** ****** *** ************ ** *****

Tel: 678-***-**** Email: ********@*****.***

Objectives:

To utilize my skills and abilities in impacting the success and growth of clinical research group, in becoming and/or sustaining its reputation as a leader in the clinical research industry.

oMain goal - To promote healthy clinical research, by safeguarding the rights and welfare of trial patients always.

Qualifications:

Experience in documenting and assisting in clinical trials research.

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

Proficient in Electronic Data Capture, Clinical Trial Management System (CTMS) and Electronic Patient System.

Comprehensive knowledge of applicable sponsor SOPs for site monitoring.

Strong organizational, computer, and problem-solving skills.

Ability to perform SWAT, PSSVs, SIVs, IMVs, and COVs per company timelines and deadlines.

Thorough knowledge of FDA and GCP principles and regulations.

Strong analytical, research, and trial preparation skills.

Detail-oriented, fast learner and excellent listener.

Therapeutic Experience:

CNS – Parkinson Disease, Chronic Pain

Dermatology -- Acne

Oncology – Non - Small Cell Lung Cancer, Solid Tumor

Medical Device – Cardiac Pacemaker

Cardiovascular - Stroke, Heart Failure

Immunology – Rheumatoid Arthritis

Endocrinology - Diabetes type II

Work Experience

Clinical Research Associate (CRA II)

Premier Research [Oct 2014 – Present]

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.

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

Possess knowledge in the maintenance of regulatory binders.

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

Perform drug accountability.

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

Assure consistent compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference of Harmonization (ICH) and GCP guidelines. Ensure guidelines are also in accordance with Company and Sponsor SOPs.

Attend Investigator Meetings and study-specific training for assigned trials.

Act as primary liaison for assigned study sites while on-site to convey project information, answer questions and in accordance with the CTM escalation pathway to resolve site related issues.

Complete Site Selection, Site Initiation, Routine Monitoring, and Close-out Visits per SOPs, and complete reports to quality standards within company specified timelines.

Develop and maintain collaborative working relationships with clinical investigative sites. Accountable for data integrity, patient safety and regulatory compliance for all assigned sites.

Assist the project team in preparation for audits/inspections; is responsible for the quality and completeness of site related performance and documentation.

Prepare, collaborate and implement Corrective Action Plans (CAP) with investigative sites, providing oversight during the process.

Update study and patient status information, and serve as Clinical Trial Management System resource for Project Manager (PM).

Document and track resolution of all outstanding site-specific protocol-related issues at every visit.

Attend clinical monitoring staff meetings and project team meetings as planned.

Assist in the preparation of study start-up documents including 1572s, CVs, Clinical Study Agreement (CSA) and amendments, investigator study files, enrollment logs, etc.

Regularly review the status of the contents of the site regulatory binder; exhibits effective time management skills.

Perform Source Data Verification (SDV) per contractual requirements.

Assure timely completion and submission of Case Report Forms (CRF) per Clinical Monitoring Plan and/or Data Management Plan.

Ensure timely and accurate completion of Data Clarification Forms. Adept with multiple data capture systems/methodologies in course of monitoring.

Maintain awareness of key study performance indicators for my sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs.

Conduct periodic monitoring activities with the investigative sites, including reviewing case report forms (CRF).

Monitor clinical trial management performance.

Communicate with clinical team members and participate in team meetings and updates.

Develop and maintain good relationships with investigators and site workers.

Oversee field monitors and site activities in accordance with the Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations.

Review trip reports and track scheduling, report submission metrics, site deviations and action items.

Manage site and monitoring issue prevention, escalation and corrective actions.

Develop, execute, manage and ensure compliance of the Monitoring Plans.

Adept at creating training materials and study tools for sites and CRAs use.

Possess knowledge in implementing, enrollment and recruitment strategies.

Understand assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.

Ensure validity of study by identifying/resolving discrepancies and obtaining missing data.

Clinical Research Associate (CRA I)

PRA Health Sciences (PRAHS), [Mar 2012- Sept 2014]

Responsible for and managed all aspects of study site monitoring per SOP, GCP, and ICH guidelines. Site monitoring includes pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites and maintenance of study files.

Managed recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation and the organization of meetings.

Took ownership of reporting Serious Adverse Event (SAE), production of reports, narratives and follow-up of SAEs.

Verified adequate investigator qualifications, training and resources, including facilities, laboratories, equipment and staff.

Managed site progress by tracking regulatory submissions, recruitment, case report form (CRF) completion and data query resolution.

Involved in the submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested.

Managed sponsor generated queries efficiently and take responsibility for study cost effectiveness with CTM.

Prepared for and attended Investigator Meetings (IM) as asked by CTM.

Performed management of study site activities, to ensure the integrity of clinical data is in adherence to all applicable regulatory guidelines.

Provided clinical and technical support for junior Clinical Research Associates and administrative staff.

Maintained current regulatory documentation per Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan.

Participated in and coordinated TMF and on-site audits as requested by CTM.

Responsible for site management and site staff performance to include monitoring clinical trials.

Participated in site visits; guaranteeing compliance with all protocol requirements.

Prepared and distributed case report forms (CRF), study reference manuals and monitoring guidelines and manuals.

Assured effective patient identification and recruitment plans are in place always.

Ensured timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations.

Made sure proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials are put in place.

Contributed to developing and writing clinical protocols, case report forms, and other study aids for investigational products by addressing issues and interacting with appropriate personnel.

Maintained study files by reviewing and archiving critical documents such as IRB approvals, FDA 1572 and adverse experience forms as well as all study related correspondence.

Monitored study master files at clinical research organization.

Knowledgeable in the areas of clinical research and regulatory affairs as related to clinical studies.

Acquired, analyzed and evaluated clinical data gathered during research and assures accurate, and complete documentation of patient care and protocol execution.

Travelled to study sites and monitored/ co-monitored progress of studies. Collected, reviewed and corrected case report forms in accordance with study specific timelines.

Clinical Trial Assistant (CTA)

PRA Health Sciences (PRAHS), [Jan 2009 - Feb 2012]

Reviewed datasets to ensure data quality using basic SQL commands as needed.

Followed test scripts to perform dataset and data reporting tool validation.

Reviewed routine data verification and quality control, ensuring data integrity and consistency with prescribed protocol.

Reduced CRA time on-site by communicating with Investigators, Study Coordinators, and Study Nurses to resolve data discrepancies and queries prior to CRA monitoring visits.

Tracked study progress and subject appointments; maintained databases and spreadsheets.

Completed Case Report Forms; assisted Study Coordinators with IRB submissions, subject recruitment, screening and enrollment; coordinated Informed Consent/HIPAA form translations.

Worked with vendors and cross functional departments to perform SAE, IVRS and Lab reconciliation.

Assisted with development and maintenance of clinical trial website to recruit research subjects.

Reviewed Case Report Forms and evaluated source data to ensure integrity.

Managed internal and external user accounts in accordance with 21 CFR Part 11.

Academic Background

University of Lagos - UNILAG

Bachelors of Science in Business Administration

Clayton State University

Diploma - PeopleSoft Certification

Certifications

Introduction to Clinical Research - The Global Health Network

The Study Protocol 1&2 - The Global Health Network

ICH Good Clinical Practice E6 (R2) - The Global Health Network

Data Safety and Monitoring Board for Clinical Trials - The Global Health Network

Computer and Software Application

EDC: Inform, Medidata Rave, OCRDC

IVRS: Almac, IMPALA, Clinphone

CTMS: Homegrown CTMS, eClinical, IMPACT, Bracket

SQL, PeopleSoft Financial

Contact this candidate