Clinical Research Manager

Moses K. Abiara

Laurel, MD *****

240-***-**** adcgss@r.postjobfree.com

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EDUCATION

New York Institute of Technology

New York, NY (2002)

B.S. Architecture

THERAPEUTIC EXPERIENCE

Oncology: Multiple Myeloma, Renal Cell Carcinoma

Central Nervous System: Insomnia, Major Depression, Migraine

Cardiovascular: Hypertension

Respiratory: Emphysema

Infectious Disease: Pneumonia

Nephrology: Chronic Kidney Disease, Renal Failure

PROFESSIONAL EXPERIENCE

August 2017 – Present

PPD, Home Based, MD

Clinical Research Associate II

Manage and monitor different aspect of clinical trials according to the study protocol, SOPs, ICH-GCP and FDA guidelines for clinical trials.

Verify the qualification of potential clinical trial sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.

Prepare and report the site status information to team members, trial management, and updates trial management tools.

Implement and monitor clinical research to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines.

Review and verify accuracy of clinical trial data collected from investigative sites.

Verify that Informed Consent forms are obtained, written and signed by the clinical trial subjects prior to their participation in the study.

Escalate site on trial related issues in accordance with sponsor’s SOPs until the said issues are addressed or closed.

Ensure that sites report and document Adverse Event (AE), Serious Adverse Event (SAE) and all other safety issues appropriately.

Ensure site is adhering to protocol and abiding by the inclusion and exclusion criteria as stated in the protocol.

Conduct site equipment’s inspection and site SOP to ensure patient safety and adherence to protocol.

Ensure that drug accountability logs are kept and procedures on investigational products are followed.

Ensure that the PI and the site staffs have a proper understanding of the protocol, and re-train site staff on any violation of protocol.

Reconcile the Site Master File with the Trial Master File and also maintains site's regulatory binder and corresponding TMF.

October 2014 – August 2017

PPD, Home Based, MD

Clinical Research Associate I

Conducted site qualification, initiation, interim monitoring and study closeout visits for Phase 1-3 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines.

Conducted all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives.

Ensured quality of data submitted from study sites and assured timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

Ensured safety and protection of study subjects through compliance with the study monitoring plan, ICH Guidelines, and applicable regulations.

Appropriately reported and escalated serious or outstanding issues to project team member(s) as defined in the study monitoring plan.

Implemented appropriate activities to ensure the site met the enrollment target within the agreed timeline.

Reported monitoring activities and studied site conduct accurately and completely.

Prepared and submitted written reports, both monitoring and administrative, in a timely, concise and objective manner.

Proactively identified issues that may impact enrollment and recruitment timelines and provided objective comments regarding these issues.

July 2012 – October 2014

PPD, Rockville, MD

Clinical Project Assistant

Assisted the Project Manager in the overall project management to ensure that sites adhere to the study protocol, ICH GCPs, and company SOPs

Co-monitoring and monitoring responsibilities on-site under the assigned lead CRA’s direction

Performed Pre-study visits, Initiation visits, Routine Monitoring Visits and Close-out visits.

Source Document Verification: Analyzed and evaluated clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, and ICH Good Clinical Practice (GCP) guidelines.

Conducted accountability of investigational product during study visits and ensured the proper storage and handling of investigational product.

Review of regulatory documents and Essential clinical research documents required for study initiation.

Assisted team members and clinical team leader (CTL) with designated administrative tasks in support of clinical trial execution and management

Maintained and managed data entry into subject enrollment tracking systems

Prepared, managed, and distributed clinical documentation and reports as needed

Assisted with coordination and distribution of clinical trial supplies (excluding investigational products)

Managed case report forms (CRF) and clinical data flow

SKILLS

Ability to adhere to company’s strong work culture

Provides on time business deliverables to clients and company

Great oral and written communication skills.

Effective organizational and time management skills.

Ability to multi-task and perform well under demanding working environment.

Working knowledge and experience in FDA, ICH-GCP, applicable SOPs/Guidelines.

Strong attention to detail.

COMPUTER EXPERIENCE

EDC (Medidata RAVE, Inform)

CTMS (VEEVA, Oracle Siebel)

Microsoft Outlook Suite, Mac OS, Google + applications etc

References: Available upon requests

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