Abdulaziz Obalola

Clinical Research Associate II- Theorem Clinical Research

Chicago, IL *773-***-***** acfnjy@r.postjobfree.com

Regional Clinical Research Associate

Over 5 years of experience in clinical research as a skilled Clinical Research Associate with

pharmaceutical and cross-functional experience. A highly professional Clinical Research

Associate with extensive monitoring experience in many therapeutic areas and phase II and

phase III of clinical trials.

PROFESSIONAL SKILLS

• Over 5 years of experience in clinical research with clinical research organizations.

• Well-versed with Phases II and III experience.

• Strong knowledge of medical terminology.

• Excellent communicator and interpersonal skills.

• Team oriented, strong organizational skills with attention to details.

• Excellent ability to perform detailed record keeping.

• Proficient in MS Office software (Excel, Spreadsheet, Outlook, Access, Word processor,

PowerPoint)

THERAPEUTIC AREA OF EXPERTISE

Cardiovascular - Pulmonary Hypertension

Endocrinology - Diabetes II

Influenza - H1N1 and Psoriasis

CNS - Peripheral Neuropathy

PROFESSIONAL EXPERIENCE

Theorem Clinical Research- King of Prussia, PA January 2013- Present

Clinical Research Associate II

• Perform and coordinate assigned tasks of the process of clinical monitoring in accordance

with the global SOPs (Standard Operating Procedures) and GCPs (Good Clinical

Practices) to assess the safety and efficacy of IPs (Investigational Products) and/or

medical devices.

• Retrieve and archive relevant documents as per Sponsor or PRA standard operating

procedures.

• Ensure that the investigators understand their obligations when signing the form FDA

1572, FDA regulations governing the use of investigational products, Good Clinical

Practices, details of the protocol and the CRFs (Case Report Forms) and overall

objectives and expectations in regard to their participation in the clinical trial.

Abdulaziz Obalola

Clinical Research Associate II- Theorem Clinical Research

Chicago, IL *773-***-***** acfnjy@r.postjobfree.com

• Maintain frequent telephone contact and/or email contact with the study team and the

investigative sites to ensure prompt resolution of any issues and to fulfill requirements of

the contract.

• Verify source document of subject data and CRF data to ensure data consistency and

integrity and the protection and welfare of human research subjects.

• Ensure proper essential documents are in place before trial start-up and on an on-going

basis throughout the study as part of the continuous file audit review process.

• Responsible for collecting and verifying of essential regulatory documents.

• Provide protocol training to PI (Principal Investigator) and site personnel; served as the

primary site resource for protocol and procedural questions.

• Develop and maintain relationships with collaborating investigators, research centers,

sponsors and vendors.

• In-depth documenting of all observations in reports and letters in a timely manner,

according to accepted business writing standards. Ensuring that serious site issues or

protocol were immediately raised to the attention of the clinical team management,

clinical operations management and project management either by phone or in writing as

the degree of seriousness dictates.

• Generate and resolve queries according to data collection timelines.

• Ensure financial stewardship by incorporating looping of site visits and scheduling travel

as efficiently as possible.

• Control IP accountability through physical inventory and records review.

• Generate and resolve data queries as required; assisting with data listings as required.

• Establish and maintain collaborative working relationships with site personnel, Sponsor

representatives and vendors.

• Control trial supplies ordering, dispatch, return and destruction, where applicable.

• Ensure sites comply with the protocol and applicable regulations (IRB/FDA/ICH/GCP).

• Conduct and ensure proper trial closeout and retrieving of trial materials as required by

Monitoring Plan.

OCKHAM RESEARCH- Cary, NC June 2009- December 2012

Clinical Research Associate I

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

issues from visit to visit.

• Participated in on-site audits and TMF (Trial Master File) as requested.

• Assured timely completion and submission of CRFs according to DMP (Data

Management Plan) and/or CMP (Clinical Management Plan)

Abdulaziz Obalola

Clinical Research Associate II- Theorem Clinical Research

Chicago, IL *773-***-***** acfnjy@r.postjobfree.com

• Attended project team meetings, clinical committees and clinical training sessions and

clinical monitoring staff meetings according to the project communication, monitoring

and/or training plans.

• Assisted with the preparation of study start up materials and tools, as requested.

• Maintained current regulatory documentation according to TMF plan and ERDG

(Essential Regulatory Document Guidelines)

• Assured compliance with ICH (International Conference on Harmonization) and GCP,

States regulations, sponsors SOPs (Standard Operating Procedures) and CRF.

• Assured timely and accurate completion of DCFs (Data Clarification Forms)

• Performed SDV (Source Document Verification) according to contractual requirements.

• Assumed responsibility for site management and site staff performance including:

Monitoring all types of clinical trials

Participating in all types of site visits

Assuring PI (Principal Investigator) integrity

Assuring compliance with all protocol requirements

Assuring effective patient identification and recruitment plan is in place

Regularly performing IP (Investigational Product) accountability

Regularly reviewing the status of contents of the site Regulatory Binder

• Assured timely reporting of AEs/SAEs and Protocol Violations.

• Maintained awareness of key study performance indicators for own sites, e.g. patient

enrollment, SAEs (Serious Adverse Effects).

• Performed clinical data listings reviews as needed.

• Attended investigator’s meetings as requested.

• Updated study and patient status information and serves as (CTMS) resource for

PM/LCRA.

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

• Completed and submitted visit trip reports according to SOP requirements.

OCKHAM RESEARCH- Cary, NC February 2008- May 2009

Regulatory Specialist

• Maintained logs and records of all clinical study programs and assisted in filing and

preparing presentations in both graphic and media format.

• Collected, processed and assisted in the compilation and verification of sample, research

data, and specimens (following strict protocol and detailed instructions)

• Managed the front desk including subject reception/scheduling/screening.

• Assisted with routine data analysis and interpretation using data analysis programs.

Abdulaziz Obalola

Clinical Research Associate II- Theorem Clinical Research

Chicago, IL *773-***-***** acfnjy@r.postjobfree.com

• Provided administrative support in the ordering and shipping of supplies, generation of

checks for study payment, coordination of department training requirements,

creation/revision ordered study-specific supplies.

• Ensured drug supply, storage and packaging conditions as per the manufacturer

requirements and quantity as per the study and regulations requirement, receipt of drug

from sponsor for all studies.

• Collaborated with various teams to administer logistics and drug shipments and ensure

optimal safety and maintain track of all management files and tools and participate in

various meetings with clients and investigators.

• Conducted data collection, source data verification and generated the quality control

reports for the Data sheets generated by Clinical Data Management from the source

documents and checked reports for the compliance.

• Generated quality control reports for the ongoing study activities, Clinical facility, Drug

store, Subjects emergency medicines and checked them for compliance.

• Assisted Principal Investigator in protocol and clinical study report preparation.

• Verified maintenance and calibration of research equipment, and ensured proper logistics

of laboratory collections, processing, storage and shipment of specimens.

• Entered data from forms and documents into databases and other documents.

• Worked under specific instructions to assist with routine tests, experiments, and

procedures.

EDUCATION

Northeastern Illinois University- Chicago, IL

Bachelor of Science, Biology

Harold Washington College- Chicago, IL

Associate in Science

SYSTEMS AND COMPUTER SKILLS

Microsoft EDC IVRS CTMS

MS Outlook OCRDC IMPALA CASCADE

MS PowerPoint Inform Almac eClinical

MS Word Medidata Rave

MS Excel

References available upon request.

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