Clinical Research Associate

Paul C Agba Phone: 713-***-****

PAUL C AGBA

***** **** ******** *** *** 1536, Houston TX, 77099

Telephone: 713-***-**** Email: *******@*****.*** CAREER OBJECTIVE

Experienced Clinical Research Associate seeking a challenging and rewarding Clinical Research Associate

(CRA) position that will utilize my clinical site monitoring and general management skills and experience to coordinate, monitor and manage all aspects of clinical trials in accordance with the ICH-GCP guidelines, FDA regulations, standard operating procedures and study protocol. SUMMARY OF SKILLS:

Phase I-IV clinical trial monitoring experience

Knowledge of ICH GCP guidelines

Excellent working knowledge of EDCs, CTMS, IVRS, EMR systems

MS OFFICE: Word, Excel, Power Point, Outlook, Microsoft Project

Updating of Investigator Brochure

Participate in development of informed consent forms

Design CRFs and send draft CRFs for review

Development of informed consent forms

Knowledgeable in current clinical research governing laws and regulations.

Adept at adverse events (AE/SAE) reporting according to regulations and company policy

Proficiency in reviewing protocol compliance, focusing on inclusion/exclusion requirements

Thrives in both independent and collaborative work environments.

Proficient in prioritizing and completing tasks in a timely manner, yet flexible to multitask when necessary

Proven ability to build positive relationships with patients, family members, physicians and other medical professionals.

Highly detail-oriented, with superior record retention and time management skills.

Ready and willing to accommodate frequent local, domestic or international business travels. THERAPEUTIC AREAS:

Oncology: Prostate Cancer, Lungs

Cardiovascular: Hypertension

Infectious Disease: HIV

Respiratory: COPD, Asthma

CNS: Alzheimer Disease

PROFESSIONAL WORK EXPERIENCE:

The Clinical Research Centre, Inc., Dallas TX Jan 2013 – Present Clinical Research Associate I-II (CRA-Home Based)

Responsibilities:

Assist in the identification of potential study sites.

Identify/select investigators who will be responsible for the conduct of the trial.

Set up the trial sites, which includes ensuring each centre has the trial materials, including the investigational medicinal product.

Review CRF’s, data management plans, study reports, and informed consents.

Conduct source data/document verification (SDV).

Monitor trials throughout their duration by conducting various Site Monitoring visits (including PSVs, SIVs, IMVs and COVs) to meet study expectations for different types of trials.

Perform training of the site staff to trial-specific industry standards.

Perform drug accountability ensuring that sites receive and maintain study drug according to the Paul C Agba Phone: 713-***-****

protocol.

Report adverse events according to regulations and company policy.

Write visit reports and close out trial sites on completion of the trial.

Liaise with doctors/consultants or investigators on conducting the trial.

Training the site staff to trial-specific industry standards.

Verify that data entered on the CRFs is consistent with patient clinical notes.

Collect completed CRFs from hospitals and general practices. Clinical Research Center, Inc., Dallas, TX Mar 2012 – Jan 2013 Clinical Research Coordinator

Responsibilities:

Processing of information received from pharmaceutical sponsors and clinical research organizations

Development of source files and regulatory documents

Conduct subject visits, including scheduling, delivery of oral and written informed consent, charting, medical testing (e.g., vital signs), and processing of data and samples collected during subject visits

Subject recruitment and screening

Completion of case report forms (CRFs)

Maintenance of source documents and CRF binders

Completion of data clarification forms (DCFs) during and following completion of studies

Coordinate and oversee clinical assessments of clients participating in clinical trial studies of major depression medications and Alzheimer-based medications

Reading and understanding clinical research protocols, investigator’s brochures, and other study-related materials

Communication of pertinent information to other staff members who may be involved in research (e.g., physicians, laboratory technologists).

Attendance at investigator meetings as needed, attendance at other meetings with study sponsors or their agents as needed

Conducting all work in accordance with Good Clinical Practices (GCPs), Standard Operating Procedures

(SOPs), and principles set forth in the CFR and ICH guidelines

Maintenance of study regulator documents, including screening and enrollment logs, drug accountability

logs, subject identification logs, site signature logs RELEVANT EDUCATION AND TRAINING:

The CRA Training Institute, Houston Texas USA

CRA Professional Development Certificate Program

- 250 Hours CEU

- ICH GCP Training

- Clinical Site Monitoring (site selection, initiation, monitoring and close out)

- Adverse Event Reporting

- Pharmacology for Clinical Research Professionals UNN

Geoscience (B.Sc.) - 2012

REFERENCES:

100% Flexible

Available upon request

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