Ige (Egay) Isijola
Feasterville-Trevose,PA
Summary
To work in a competitive environment on challenging assignments that will yield job satisfaction and steady professional growth. Resourceful Specialist offering expertise in problem-solving, data analysis and customer service. Adept at quickly learning new technologies and processes for driving success. Proven track record of successfully managing multiple projects and developing innovative solutions. Reliable business professional with experience in project management, process improvement and financial analysis. Proven track record of successfully streamlining business operations and reducing costs. Adept at analyzing data to identify trends and developing strategies to improve efficiency. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
16
16
years of professional experience
Work History
Senior Clinical Research Associate
PRA Health Science: Strategic Solutions
02.2013 - 11.2019
- Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner
- Knowledge of applicable SOPs, guidelines and study procedures
- Assist with protocol and CRF review
- Develop informed consent forms
- Conduct study feasibility and site selection activities
- Assist with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials
- Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities
- Assist with investigator meeting activities including organization, preparation and attendance
- Conduct site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits
- Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines
- Establish and maintain good rapport with study sites
- Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines
- Coordinate timely shipment of clinical supplies and study drug to sites
- Ensure proper storage, dispensation and accountability of clinical supplies and study drug
- Maintain adequate site tracking records
- Follow up of drug safety issues and safety reports in timely manner, if applicable
- Communicate site study issues, concerns, and progress to Clinical Research Manager, Project Manager and Clinical Team Lead accordingly
- Assist with data query form (incl
- Query process)
- Perform telephone monitoring activities in order to obtain study status information
- Development and implementation of corrective actions when appropriate
- Prepare /review all patients tracking records
- Input and maintain study information concerning subject status of financial reimbursement to sites
- Conduct and assist with administrative activities as a member of the project team
- Mentor for Site Manager and/or Site Manager II, when assigned
- Conduct on the job training and formal training to other Site Managers
- Collaborate with Clinical Research Manager/ study teams to resolve site issues
- Review study visit reports, follow-up letters and site communication generated by other site managers for timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from Clinical Team Lead or Clinical Research Manager as needed
- Participate in routine study progress meetings, face to face or via teleconference.
Clinical Research Associate II
ICON Research
01.2012 - 12.2012
- Oversees and monitors activities of assigned investigative sites and clinical trial projects throughout the duration of a clinical study to ensure a high quality execution of clinical studies, safety, adherence and compliance to designated protocol, FDA regulations, Good Clinical Practice (GCP) guidelines, and Organization policies and procedures, sponsor Standard Operating Procedures (SOPs) and all applicable regulatory requirements
- Conducts on-site monitoring visits at investigator sites including pre-study, site initiation, routine on-going and close-out activity visits
- Utilizes in-depth knowledge of GCP and research related regulatory requirements to monitor investigative site activities providing guidance and expertise to site personnel, advising investigators on what they can/cannot do, answering questions, identifying issues and ensuring protocol is consistently followed
- Ensures all site personnel are appropriately informed and trained on study specific processes i.e
- Protocol, ICF as well as maintaining their individual CVs, licenses, GCP training, etc
- Identifies knowledge gaps and takes the appropriate steps to address
- Assists with the collection, preparation - reviewing for accuracy - of regulatory and administrative documents from the investigator sites
- Identifies and investigates anomalies and apparent inaccuracies, working with the pertinent stakeholders to resolve and correct as appropriate
- Tracks progress of studies - updating and/or maintaining existing study specific trackers and/or calendars
- Reviews tables, reports and listings such as summaries of cancelled labs generated from study data to identify errors, following up to assist site personnel to correct errors, ensure data is entered correctly and provide additional re-training if necessary
- Ensures that site protocol deviations/violations and Serious Adverse Events (SAE) are appropriately prepared, tracked, documented and reported to the sponsor and IRB according to the study specific plan
- Conducts secondary review ensuring all regulatory documents are complete and up to date, including IRB approvals
- Provides feedback and results to Director of Clinical Studies highlighting incomplete documents and works with site staff to attend to gaps and anomalies
- Prepares progress summary reports for clients, project personnel, and Organization management
- Report includes updates on subject screening and enrollment progress, study progress (ahead/behind schedule), and anticipated completion date
- Identifies issues such as potential amendments to the protocol, offering recommendations and options for improvement
- Presents study specific guidelines and procedures, site data, case report form, and monitoring standards at Investigator’s Meetings and/or team meetings to ensure the successful conduct of the study
- Completes monitoring visit summary reports/checklist upon completion of each visit documenting the purpose of the visit, progress of the study and identifying any potential issues or concerns
- Participates in the recruitment of investigators and performs site feasibility assessments
- Utilizes knowledge and expertise of clinical study requirements to determine if a potential site and/or investigator would be suitable for the study
- Meets with investigators to determine needs - including appropriate resources and adequate study population - to successfully conduct the study
- Provides assessment report to Project Manager Clinical Studies
- Performs site feasibility assessments evaluating site personnel to ensure adequate research training and providing training on study and Good Clinical Practice if necessary
- Ensures on-site drug storage with limited access ensuring adequate security measures, appropriate SOPs on file and documentation
- Verifies patient data entered on CRF matches medical record data
- Generates queries to investigate discrepancies
- Makes a continuous effort to keep abreast of regulatory and scientific developments by attending training courses and reading professional journals and publications
- Applies advanced and extensive knowledge, subject matter expertise, experience and judgment to accomplish goals and tasks of a high level of complexity
- Assists in the development of study related documents, including clinical protocols, Case Report Forms and/or electronic data capture systems to ensure all required data is captured
- Reviews protocols for completeness and feasibility
- Researches, locates and interviews opinion leaders connected with a particular area/study to assess interest level in the clinical protocol
- Acts as a subject matter expert, mentor and resource for the CRA I and In-House CRA providing Provides training, support, advice and leadership as appropriate.
Clinical Research Associate II
PRA INTERNATIONAL
06.2009 - 12.2011
- Implement and monitor clinical trials to ensure sponsor and investigator obligation are being met and are compliant with applicable local regulatory requirements and ICH guidelines
- Continually reviewing applicable SOPs, guidelines and study procedures
- Actively conducting site management activities, including but not limited to site selection visits, site initiation visits, site routine monitoring visits and site close out visits
- Provide regular clinical status information to team leaders, team members and project management
- Perform source document’s verification, review Case Report Forms (CRFs) and perform query resolutions in a timely manner
- Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines
- Ensure proper storage, dispensation and accountability of clinical supplies and study drugs
- Maintain adequate site tracking records
- Establish and maintain good rapport with study sites
- Work closely with other team members to ensure timely resolution of project and/or clinical issues and obtain direction from senior clinical operation staffs
- Perform investigative site reconciliation
- Request from sites any new or updated site-related documents and review for content and consistency, and onward submission to the Central Investigator’s File
- Liaise with logistics and investigative sites on timely shipment of clinical supplies and study drugs to sites.
Clinical Research Associate I
Pharmanet, Inc.
11.2008 - 06.2009
- Actively conducted site management activities: site selection visits, site initiation visits, close out visits, interim monitoring visits, etc
- Monitored investigator compliance for the reporting of Adverse Events and Serious Adverse Events
- Documented and communicated study site progress and issues/concerns to the project team in a timely manner
- Addressed study issues/concerns with the investigator and independently offered resolution strategies and document follow-up activities and outcome
- Reviewed monitoring reports and implemented follow-up or corrective action when necessary
- Provide timely and accurate submission of time reports, expense reports, monitoring reports, and schedules as needed
- Ensured that study documentation was completely and properly maintained in accordance with the sponsor protocol, SOPs, GCPs, ICH Guidelines and FDA regulations
- Perform clinical monitoring in compliance with FDA regulations and all related SOPs.
Project Research Associate
Pharmanet Inc.
12.2007 - 11.2008
- Tracked and managed the distribution of study drug and clinical supplies as requested
- Assisted in the development of study timelines and ensured compliance
- Verified study documents e.g
- Case Report Forms, source documents and adverse events forms, which were reviewed and tracked for completeness and accuracy
- Assisted the Project Manager and CRAs in preparing necessary document to maintain consistency in the study data across all sites
- Reviewed essential regulatory documents including FDA Form 1572, site-specific or study template informed consent forms, contracts for completeness and accuracy
- Liaise with IRB and site personnel for submissions, approvals and tracking of approved documents
- Assisted in providing training to new Clinical/Project Research Associates as needed
- Monitored vendors and other service provider documents for quality of service
- Prepared key reports and documents on progress of study for Project manager
- Review report for data completeness and accuracy.
Crisis Intervention Specialist
Temple University Health Hospital, PA
Philadelphia, PA
02.2004 - 06.2006
- Member of on-call emergency response team for crisis intervention within facility.
- Provided emergency response in crisis situations to diffuse tensions and prevent violence.
- Used skills such as active listening and collaborative problem-solving daily to connect with patients and address concerns.
- Evaluated risk to client or others by gathering information and conducting assessments.
- Built safety plans to lower risk of crisis and intervened in specific manners outlined by procedures.
- Offered supportive counseling and crisis intervention to individuals in crisis.
- Implemented evidence-based interventions for substance abuse treatment.
- Evaluated patients based on mental and physical parameters discovered through interviews and standardized assessments.
- Collaborated with counselors, physicians and nurses to plan or coordinate treatment, drawing on social work experience and patient needs.
- Collaborated with mental health professionals to coordinate comprehensive care for clients.
- Interviewed clients, reviewed records and conducted assessments to evaluate mental or physical condition of clients or patients.
- Conducted comprehensive assessments of clients to develop individualized treatment plans.
- Counseled and helped to stabilize consumers and caregivers in crisis situations.
- Documented risk to each client and context of concerns.
Youth Specialist/Case Manager
Delaware County Children & Youth Services
06.2003 - 04.2006
- Liaised with multiple organizations to facilitate delivery of quality care to at-risk clients in Delaware County
- Investigated suspected abuse cases and submitted reports for follow-up or further action required
- Trained, mentored, and performed employee appraisals for staff members while working to continually grow and develop skills through conferences and research
- Studied a sample of Medicaid-enrolled women and compared the degree to which women with mental illness lose custody of their children compared to those without mental illness
- Performing data collection, analysis, and literary research as required
- Planning, scheduling, coordinating, and directing phases of research activity.
- Maintained safety and security of youth under care.
- Observed individual behaviors and suspect actions, and reported issues to supervisory staff.
- Planned and executed activities to promote skill and talent development.
- Offered constructive feedback to minors under care regarding specific actions, behaviors and words.
- Created and facilitated recreation and education activities for youths to engage in groups in safe environment.
- Delivered youth transitional assistance in areas of education, life skills and career development.
- Guided youths through admission and orientation tasks to speed up enrollment processes.
- Maintained documentation and records of training activities and group events.
- Developed individual and group programs to encourage prosocial behaviors.
- Organized and attended meetings, trainings and conferences with foster parents to deliver information on youth progress.08
- Administered outreach services to underserved communities, increasing enrollment by [Number]%.8
- Administered outreach services to underserved communities, increasing enrollment by [Number]%.8
- Administered outreach services to underserved communities, increasing enrollment by [Number]%.80
- Assisted clients in identifying community resources and connecting with appropriate services.
- Collaborated with other professionals to plan and coordinate care for clients.
- Documented client progress and activities in accordance with agency policies and procedures.
- Assisted clients in developing and setting realistic goals to promote positive change.
- Participated in interdisciplinary team meetings to coordinate care for clients.
- Developed and maintained strong relationships with community resources for successful referrals.
- Provided crisis counseling and intervention services to clients in emergency situations.
- Utilized evidence-based practices to provide effective interventions for clients.
- Administered assessments to identify clients' needs and establish treatment plans.
- Educated clients and families on mental health, wellness and recovery topics.
- Evaluated clients' social, emotional and psychological needs to create treatment plans.
Education
Post-Master’s Clinical Trials Management Certificate (Did not complete the certificate course), Drug Development, Good Clinical Practices -
Temple University Philadelphia
Master Public Health (MPH) -
Benedictine University
Lisle, IllinoisMaster Health Services Administration (MHSA) -
Strayer University
Bachelor of Science: Mathematics (Honors) -
Ondo State University
Skills
- A self-motivator and versatile individual with the ability to work under pressure Possesses good technical and managerial skills, I am an efficient self-starter, a diligent and hardworking individual with outstanding interpersonal and communication skills I am persistent and possess the ability to assimilate information very rapidly and disseminate clearly and in a concise manner
- SAS Software
- SPSS
- Access
- Microsoft Word
- Excel
- Power point
- Outlook
- Electronic Data Capture – Inform
- ORDC (Oracle Remote Data Capture)
- Medidata RAVE
- CLUBNET & PRISM
- Emergency Response
- Resource Allocation
- Technical Communication
- Management Collaboration
- Quality Assessment
- Analytical Thinking
- Quantitative Skills
- Quality Assurance
Therapeutic Experience
- Oncology: Prostate Cancer, Ovarian Cancer, Breast Cancer, Colon, Lymphoma, Rectal, Anal Cancer and Lung Cancer
- Endocrine: Diabetes, Obesity, Weight Loss
- Infectious Diseases: HIV infection, Herpes Zoster, Acute & Chronic Hepatitis
- Psychology Clinical & Neurology: Alzheimer’s, Acute pain management, Anti-Anxiety, Bipolar Disorder
- Cardiovascular disease: Hypertension, Lipids
- Gastroenterology: Abdominal pain, Crohn’s Disease, Ulcer-Peptic/Gastric
References
Excellent references available upon request
Timeline
Senior Clinical Research Associate
PRA Health Science: Strategic Solutions
02.2013 - 11.2019
Clinical Research Associate II
ICON Research
01.2012 - 12.2012
Clinical Research Associate II
PRA INTERNATIONAL
06.2009 - 12.2011
Clinical Research Associate I
Pharmanet, Inc.
11.2008 - 06.2009
Project Research Associate
Pharmanet Inc.
12.2007 - 11.2008
Crisis Intervention Specialist
Temple University Health Hospital, PA
02.2004 - 06.2006
Youth Specialist/Case Manager
Delaware County Children & Youth Services
06.2003 - 04.2006
Post-Master’s Clinical Trials Management Certificate (Did not complete the certificate course), Drug Development, Good Clinical Practices -
Temple University Philadelphia
Master Public Health (MPH) -
Benedictine University
Master Health Services Administration (MHSA) -
Strayer University
Bachelor of Science: Mathematics (Honors) -
Ondo State University
Similar Profiles
Hardik BadaniHardik Badani
Associate Director – Clinical Delivery at ICON -Previously PRA Health ScienceAssociate Director – Clinical Delivery at ICON -Previously PRA Health Science
Mary AdemolaMary Ademola
Senior Clinical Data Coordinator at ICON formerly PRA Health ScienceSenior Clinical Data Coordinator at ICON formerly PRA Health Science
Almaas EssopAlmaas Essop
Pharmacist Consultant - Online Course developer at Strategic Health SolutionsPharmacist Consultant - Online Course developer at Strategic Health Solutions
Nina McGuireNina McGuire
Commercial Cleaner at S&S Cleaning INCCommercial Cleaner at S&S Cleaning INC
Edward BenoitEdward Benoit
Sr. Data Analyst at Portnoff Law AssociatesSr. Data Analyst at Portnoff Law Associates