Clinical Research Management

PEMI OBOLANLE

*** ***** **** ******, ****** NJ **103 973-***-**** ********@*****.***

OBJECTIVE

A committed Clinical Research Associate with experience of supporting the research, with

positive difference as an individual or as a team member. Having excellent communication skills

and able to present results in a clear and actionable format for investigators, sponsors, regulatory

bodies or other consulting professionals.

Skills and knowledge

• Ensure master files comply with SOPs, GCPs and other regulations

• Maintain active study files and prepare key documents for files

• Specializes in Phase I to IV studies

• Strong Interpersonal Communication Skills

• Electronic Data Capture (EDC) System where all data collected is entered

• Excellent organizational, leadership and problem-solving skills

• Health Insurance portability & Accountability (HIPAA)

• Good knowledge and understanding of drug accountability

• Document management (CRF, e-CRF and TMF)

• Excellent decision making, interpersonal and communication skills

• Excellent communication skills (written and verbal)

• Proficiency in Microsoft Office, Excel, PowerPoint, Outlook and Oracle clinical

• Assist with mentoring and training new staff, as assigned

PROFESSIONAL EXPERIENCE

RADIENT RESEACH (Contract) February 2104 - April 2015

CLINICAI RESEARCH ASSOCIATE

• Serve as a field based monitor and key resource for the identification of potential

investigators for clinical studies ensuring that identified investigators have the requisite

experience, facilities, personnel and access to subjects for a successful execution of the

clinical study

• Monitor data and verify source records

• Assist in the collection, review and tracking of essential pre-study documents as required

to enable timely and seamless study start up process

• Perform a reconciliation of the Site Regulatory Binder versus the Sponsor’s TMF and

retrieve missing documents for filling in the appropriate file.

• Conduct site initiation visits to open up the site for the conduct of the clinical study and

ensure that site is properly trained on the protocol, ICH GCPs, relevant FDA regulation,

and the clinical trial processes

• Ensure that site has received all study supplies ahead of the initiation visit

• Ensure that the site is to relevant regulatory requirements, sponsor and site SOPs as

agreed at the beginning of the study

• Responsible for the periodic monitoring visits to investigational sites to perform on-site

review of patient data, source documents, and CRFs for completeness and consistency,

and to confirm that subjects enrolled met the eligibility criteria set in the protocol

• Ensure site personnel are trained

• Review Informed Consent Forms and ensure that subjects are properly consented before

any study procedure was done

• Reconcile trial document throughout the trial in preparation for trial

• Perform Source Document Verification (SDV) to ensure the accuracy and completeness

of the CRF and that CRFs are consistent with source documents

• Effectively interacted with team members to drive project goals

• Coordinate with document management system support staff to ensure appropriate data

dictionaries are updated for new trials

• Screened potential subjects for protocol eligibility. Presented trial concepts and details to

the subjects, participated in the informed consent process, and enrolled subjects into the

studies

• Responsible for accurate and timely data collection, documentation, entry, and reporting

• Responsible for ensuring that clinical investigative sites: protect the subjects rights and

safety, adhere to clinical protocols, Standard Operating Procedures, ICH guidelines, Good

Clinical Practices and FDA guidelines

• Ensure that the site regulatory binders are properly maintained and that all essential

documents are filed, current and complete

• Review lab supplies and ensure that site has received adequate supply of lab kits and that

expired kits are destroyed appropriately.

• Review regulatory documents, investigational product accountability, Case Report Form

source document verification and prepare site visit reports

• Perform a reconciliation of the Site Regulatory Binder versus the Sponsor’s TMF and

retrieve missing documents for filling in the appropriate file

• Assist in collecting data management queries and data clarification forms

• Ensure that SAEs are reported to the sponsor and the IRB in a timely fashion and that the

site is regularly reviewing IND safety reports

• Review regulatory documents, investigational product accountability, Case Report Form

source document verification and prepare site visit reports

TEVA, Horshman (Contract) June 2013 – December 2013

Clinical Research Coordinator

• Provides support for the preparation of clinical study reports, annual reports, IND updates

and other study or regulatory documents, as required

• Serves as a resource for clinical trial sites and can triage questions/needs, as appropriate

• Files and maintains study documents in the study Trial Master Files (TMFs)

• Performs ongoing and final study-level and site-level TMF reconciliation

• Provides accurate progress reports on assigned tasks and projects

• Contributes to wider organizational goals and/or activities as assigned

• Ensures study compliance by understanding and applying all relevant SOPs

• Assist in preparation of documents including regulatory document templates, study

binders, study communications and presentations

• Collect and track regulatory document for submission to central and local IRB and verify

IRB approval

Clinical Research Academy of America February 2013 May 2013

Clinical Research Coordinator, Intern

• Participates in meetings with sponsors, monitors and regulatory authorities, as necessary.

• Submitting regulatory documents to IRB and Sponsor

• Obtaining physician signatures and getting voluntary subject consent

• Ensure submission of document are accurate

• Ensure proper study product storage and accountability

• Maintaining study files

• Documenting an SAE/AE, including :describing the event and treatment

• Maintaining communication and correspondence (by telephone, email, fax ) with subject,

sponsor, monitor and other site study personnel

Education

Seton Hall University, South Orange, NJ - Bachelor of Science- Nursing Dec. 2014

Essex county college, Newark, NJ Epic certificate…….April 2014

ACR (Advance Clinical Research), Edison, NJ January 2014

References

Provided on request

Contact this candidate