Clinical Research Data

Babalola Obisesan (BABS) *****, Briarwood Drive, Apt 231 Laurel MD 20708 Phone: 347-***-****. *********@*****.***

Experience Summary

A dedicated Clinical Research Associate (CRA) seeking a challenging and permanent position as a senior clinical research monitor in a leading pharmaceutical, biomedical or clinical research organization (CRA)

CAREER HIGHLIGHS

Over 8 years of experience in clinical research

Sound knowledge of Good Clinical Practice and FDA regulations

General knowledge of regulatory requirements and guidelines governing clinical research

Comfortable with technology and ability to learn new systems quickly

Experienced with a wide range of EDC, IVRS and CTMS systems

Strong knowledge of MS Word, Excel, PowerPoint and Outlook

Pays strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines

Able to professionally interact and communicate with vendors and individuals at all levels of the organization

Able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands

Able to work successfully within a cross-functional team

Relevant Experience

Clinical Research Associate (Contractor) May, 2013 – Present

Nouveau Research LLC., Wilmington, DE

Serve as primary liaison between sites and the project management team.

Initiates, monitors and conducts study close-out visits at clinical centers and independently ensure that site is conducting the clinical trials according to ICH GCPs, Ethical requirements, FDA Regulations and all applicable state regulation.

Schedules and conducts monitoring visits in accordance with the Monitoring Plan inclusive of training of study site personnel, oversight to ensure protocol adherence, data verification of source documents and accountability of investigational study supplies.

Troubleshoot and resolve routine study conduct issues and escalate to the project manager as appropriate.

Responsible for study enrollment tracking and reporting at individual study centers

Assist sites in preparing for sponsor audits as necessary

Participate in team meetings to develop and maintain study timelines for assigned studies

Manage all aspects of study conduct at the site to ensure compliance including site binder review and reconciliation with the sponsor’s Trial Master File

Assists with development of clinical trial documents such as study newsletters, etc.

Brainstorm with the assigned sites on subject recruitment and retention strategies

Ensures that site has an adequate supply of clinical study supplies including investigational product, lab kits, and other study supplies.

Assists with review of study reports including tables, listing and figures as needed

Work collaboratively with the study manager to execute investigator contracts in accordance with the departmental budget

Assures compliance of clinical studies with Good Clinical Practice (GCP). Federal regulatory requirements and company Standard Operating Procedures (SOPs)

Prepares site status updates and site visit reports in a timely manner

Ensures prompt reporting and follow through of protocol deviations, adverse events and serious adverse events and ensure that the IRB is updated as necessary.

Collaborates with data management on data clarification processing, review, and verification of investigator clarification responses

Mentors more junior Clinical Operations staff and participates in the on boarding of new CRAs by performing co-monitoring and accompanied visits

Assist in presentations during investigator meetings and clinical trial coordinator training retreats

Responsible for additional projects, as required.

Clinical Research Associate (Contractor) August, 2011 – May, 2013

Roxane Laboratories, Inc., Columbus, OH

Perform evaluation of potential investigators/sites for the planned clinical studies and recommend sites that meet the required criteria for the study.

Assist in the start-up process and facilitate the collection of essential documents from Investigational sites.

Visit sites to perform initiation visits and ensure that sites are properly trained and prepared for the clinical trial.

Perform interim monitoring visits during the study, and study closeout at the end of the study according to the sponsor’s monitoring plan and study timeline.

Prepare and submit visit reports for all site visits within the visit report timeline.

Verified documented informed consent for each subject and assured the protection of the rights, safety and well-being of human study subjects.

Provide ongoing accountability of Investigational product shipped to site ensuring that they are stored, dispensed, returned and disposed according to the study protocol and investigational product handling manuals.

Ensure that investigator and site compliance with the study drug protocol, overall clinical objectives, and ICH Good Clinical Practice (GCP) guidelines.

Assure that serious adverse events are correctly documented and reported, and that subjects are provided adequate medical care until the issue is resolved.

Review all case report forms and compare them to source documents during site visits to ensure that site is adhering to the protocol and that data submitted via the CRF are complete, correct and credible.

Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.

Demonstrated ability to manage, with minimal supervision, sites participating in complex clinical studies to ensure adherence to the study protocol, ICH GCPs and all applicable regulations.

Manage the overall activities of site personnel and motivate/influence them to meet study objectives and timelines

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

Ensure safety and protection of study subjects according to the monitoring plan, Company SOPs, ICH Guidelines, and federal regulations.

Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.

Appropriately escalate serious or outstanding issues to senior level CRA/Clinical Operations Manager (COM) or the appropriate project team member(s).

Ensure regulatory inspection readiness at assigned clinical sites.

Report monitoring activities and study site conduct accurately and completely.

Review, clarify, and obtain data changes via queries with site personnel and assist in reviewing data listings and query generation.

Liaise with clinical sites to address questions or problems related to clinical studies.

Answer questions if applicable, or identify proper resources where necessary to resolve issues raised by sites.

Responsible for reviewing and tracking of study documents (e.g., CRFs, source documents, AEs) to ensure completeness and accuracy.

Complete all administrative tasks associated with the role such as Expense Reports, Calendar Updates, Systems Updates, etc.

Perform Closeout visit to accomplish all closeout visit tasks including: verify that the investigator’s study files are complete; Ensure that regulatory requirements for retention of records are understood; review final reporting requirements with the investigator; Ensure all data is complete; Ensure that all supplies are returned, destroyed; Return all study equipment back to the sponsor; Ensure that all SAEs have been reported to the IRB.

Complete special projects as assigned.

In-House Clinical Research Associate November, 2009 – August, 2011

Roxane Laboratories, Inc., Columbus, OH

Support Site Identification, Recruitment & Qualification

Be first line of contact to direct or address non-medical site questions

Perform study tracking to ensure that all study files and documents are accurate, current and complete.

Perform essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs.

Provide general support to the Lead CRA and CRA in order to manage the investigator sites and ensure compliance

Develop or contribute to newsletters for assigned studies based on information provided by Project Team.

Maintain FAQ list for assigned trial(s)

Confirm and track that all key site personnel have project specific training.

Document site and sponsor contact and study interactions in a timely and professional manner.

Assist with resolution of investigational site/data queries.

Liaise with project team members regarding study site issues.

Provide quality review of the informed consent template.

Track submission to and approval from IRB, 1572 changes (including obtaining medical licenses and CVs related to these changes) correspondence, site changes.

May provide study-specific direction, training and mentoring to CRAs, and support staff as appropriate, and may provide guidance to other team members.

Travel to sites and meetings as needed.

Other duties as assigned and may change with change in studies/Advanced Clinical needs.

Project Support Specialist April, 2008 – November, 2009

Adolor Corporation, Exton, PA

Assist the project manager in the coordination of documentation associated with conducting clinical studies.

Provide in-house support to CRAs and other clinical staff in the conduct of clinical studies.

Support the creation of standardized clinical trial tools, processes and SOPs.

May be responsible for exporting the results of studies, test results, and data entry

Provide support to clinical research including, but not limited to, maintenance of documentation, clinical tracking and information retrieval.

Perform general administrative functions such as, scheduling meetings and/or travel arrangements for clinical staff, requesting proposals/contracts from CROs, budget tracking and helps to ensure payments are on time.

Perform data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, vendors, etc.

Serve as key central contact for communications, correspondence and associated documentation.

Perform duties such as, clinical form design, and filing of correspondence, lab reports, Clinical Monitoring Reports, and other study documents.

Responsible for document retrieval.

Maintain and ensures all documentation are in a state of audit-readiness.

Responsible for collection, dissemination, and/or tracking of regulatory documents as required.

Coordinate study logistics, documents, drug shipments, enrollment and safety.

Perform all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards.

Support other projects as assigned

Clinical Data Associate March, 2006 – April, 2008

Adolor Corporation, Exton, PA

Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).

Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).

Enters test data for data entry screens and for edit checks.

Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the CRF database.

Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Clinical Data Validation Plan for the assigned projects.

Resolves queries correctly answered and re-queries where appropriate.

Provides assistance and guidance to other Clinical Data Associates with the above tasks.

Reviews queries, self-evident corrections and the application of global rulings, proposed by less experienced Data Management staff.

Reviews queries raised by staff responsible for the coding of CRF terms for adverse events, medical history, and medications against medical coding dictionaries.

Issues queries to sites.

For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly.

Ensures that data from external databases/datasets such as laboratory databases, or electronic diary datasets are consistent with data in the clinical database.

Uses the specified process to document and query any such discrepancies found with the appropriate party.

For paper studies, performs internal audit and quality control checks on listing output from database against Case Report Forms (CRFs) and Data Clarification Forms (DCFs).

For EDC studies, performs DM Review (Rave) and/or other internal audit and quality control checks as required per applicable EDC systems.

For paper studies, ensures all Case Report Forms (CRFs) and Data Clarification Forms (DCFs) received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.

Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload.

Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts.

Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries.

Trains and mentors data management staff providing timely feedback to trainee and management as appropriate.

Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences.

Business Development Officer June, 2005 - March, 2006

Crusader Sterling Pensions Limited, Lagos Nigeria

Achieved 13% increase in market share in 2 consecutive quarters.

Oversaw 2005 N2billion Assets under Management and acquisition of 25% market share in the pension industry.

Led sales team that created Company business development strategies in Lagos & South West Nigeria by leveraging brand awareness of parent company, Crusader Insurance Plc.

Achieved 100% retention of accounts Anchored enrollment of State Government account through relationships with career civil servants, political office holders and various staff unions. Account remains among the top 10 in the Company database.

Monitored sales of Retirement Savings Accounts to employees recording successful transactions, number of account opened, cost and customer satisfaction rate.

Closed new business deals by contacting potential customers, exploring and pursuing new opportunities.

Protected organizational values by keeping information confidential and representing them with integrity.

Collaborated with marketing team to create proposals that spoke to client needs and objectives.

Planned and prepared presentations and provided feedback to management

Education

Master of Science (M.Sc.) in Business Intelligence In progress

Saint Joseph’s University, Philadelphia, USA

Bachelor’s Degree in Health Science/Administration 2003

Olabisi Onabanjo University, Ogun state, Nigeria

References

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Available on request

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