ERIKAN ENYONG
Los Angeles,California
Summary
Dynamic Drug Safety Specialist with expertise in pharmacovigilance, with experience focused on ICSR processing and regulatory submissions. Proven ability to enhance regulatory compliance, and proven safety reporting processes. Skilled in MedDRA coding and fostering collaboration across regulatory and medical teams, ensuring high-quality case processing and timely submissions.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Drug Safety Specialist
Medi Pharm Solutions
Somerset, NJ
08.2025 - Current
- Assisted in preparation of regulatory submissions, including new drug applications and amendments.
- Collaborated with regulatory affairs teams to ensure accurate submission of ICSRs to authorities.
- Identified trends in adverse events to support risk management strategies.
- Reviewed incoming adverse event reports to assess causality and prioritize follow-up actions.
- Conducted reviews of MedDRA coding practices to ensure compliance with industry standards.
- Provided recommendations on drug dictionary usage to enhance safety evaluations and compliance.
- Managed revisions of narratives based on new information or changes in regulations.
- Trained team members on best practices for managing reporting timelines and deadlines.
Clinical Research Monitor
ONCOtherapeutics
Los Angeles, California
06.2024 - 02.2026
- Executed comprehensive site visits throughout assigned clinical research project life cycles, including PSSV, SIV, IMV, and COV.
- Conducted site initiation visits, training personnel on Sponsor and regulatory requirements for study execution.
- Monitored investigative clinical sites via interim monitoring visits per sponsor clinical monitoring plans.
- Ensured protocol adherence and regulatory compliance through 100% source document verification with electronic data capture systems.
- Maintained Investigator Site Files by updating essential documents, including Institutional Review Board approvals.
- Verified informed consent processes for accuracy and addressed discrepancies with corrective actions as necessary.
- Confirmed eligibility of subjects based on inclusion/exclusion criteria to support appropriate randomization.
- Reviewed Adverse Events, Serious Adverse Events, and SUSARs to ensure timely reporting to the Sponsor.
Clinical Research Program Assistant (Quality Assurance) (Contract)
The Angeles Clinic Research and Institute Affiliate-Cedars Sinai
03.2024 - 06.2024
- Ensure that all processes contributing to the performance of a clinical trial are conducted properly.
- Troubleshoot clinical trials and activities.
- Manage and maintain databases for the quality system.
- Prepare and assist in preparing annual reports and quality trending reports.
- Report on the status of the quality levels of staff, systems and production activities.
- Preside over improvement programs.
- Evaluate quality events, incidents, queries, and complaints.
- Keep up to date with all related quality legislation and compliance issues.
- Compile and prepare materials for submission to regulatory agencies.
- Document internal regulatory processes.
- Ensure regulatory rules are communicated through corporate policies and procedures.
- Utilize guidance documents, international standards, or consensus standards and interpret for guidance.
- Ensure that investigator, vendor, facility and system audits are conducted.
- Communicate any critical compliance risks noted from these activities to senior management.
- Assume a lead role for the preparation, conduct, and responses to regulatory agencies.
- Provide leadership and strategy in line with global strategic objectives.
Snr. Clinical Research Associate
Providence Saint Joseph Medical Center
Burbank, CA
02.2016 - 06.2020
- Conducted day-to-day execution of clinical research protocols including obtaining informed consent, completing study procedures, and dispensing, accounting for study drugs, and documenting drug compliance.
- Responsible for recruiting prospective research subjects for clinical trials.
- Responsible for clinical communication with central and local IRBs and maintaining ethical approval for studies, from initial study approval through study amendments, annual continuations, and finally termination.
- Documented and conducted appropriate correspondence regarding adverse events, including multiple severe adverse events.
- Clinical studies in accordance with the study plan and sponsor's SOPs.
- Trained site personnel during initiation visits and managed study conduct at the site to ensure high-level site performance.
- Performed both onsite and remote source document verification to ensure the accuracy of data entered the CRF/eCRF.
- Identified and tracked protocol deviations/violations along with deficiencies during monitoring visits, and provided additional training and/or initiated corrective action as required.
- Discussed relevant visit findings with Principal Investigators via face-to-face meeting and scheduled telephone conversations to ensure proper site staff and study oversight.
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan.
- Maintains records and other documentation of training.
- Maintains subject screening logs and protocol deviation logs.
- Maintains spreadsheet tracking updates to the database of all subjects enrolled in clinical trials.
- Collaborates with PI and institutions to respond to any audit findings and implement- approved recommendations.
- Complete documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for monthly.
- Executed all aspects of site management from collaboration with in-house study team on site selection to study closeout.
- Performed site visits to verify the suitability and viability of the investigational site for the conduct of clinical studies in accordance with the study plan and sponsor's SOPs.
- Trained site personnel during initiation visits and managed study conduct at the site to ensure high-level site performance.
- Performed both onsite and remote source document verification to ensure the accuracy of data entered the CRF/eCRF.
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
- Schedules study participant appointments and serve as the patient liaison to the PI and other participating physicians.
- Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
- Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment.
- Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) to be able to answer all questions pertaining to the study posed during the informed consent process.
- Ensures that all materials for each clinical trial protocol are available for subject enrollment.
- Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.
- Performs specimen processing and shipment of biological specimen duties.
- Responsible for study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
- Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, Boston Foundation for Sight, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures.
- Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.
- Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined.
- May perform other job related duties as requested or required.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Liaised with clinical project leader to effectively resolve study-related issues.
Clinical Research Coordinator III
Southern California Oncology Research Alliance
03.2015 - 02.2016
- Management of multiple clinical research sites on all aspects of conducting clinical trials, including the protocol, informed consent, investigational product, Good Clinical Practice, and regulatory requirements.
- In addition to personally managing sites, I often led a team of Clinical Research Associates to ensure that all trial sites were being appropriately monitored.
- Assist in investigator study site selection and study start-up.
- Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs).
- Implement and monitor clinical trials to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and FDA and ICH guidelines.
- Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure “Good Clinical Practice”, and conduct close-out visits.
- Identify site issues and initiates correction plans based on monitoring reports.
- Perform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.
- Verify data in source documents that are in agreement with source, initiate data query resolution and confirm resolution in a timely manner.
- Ensure subject safety and adverse event reporting to sponsor and IRB/IEC.
- Verify drug accountability logs and storage requirements.
- Responds to requests from investigative sites in a timely fashion.
- Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines.
- Assist with the preparation of IRB applications, including protocol and informed consents and obtain Approval to conduct the study.
- Maintain appropriate correspondence with the IRB, including adverse events, annual renewals and protocol amendments.
- Create Standard Operating Procedures for each study or clinical trial.
- Conduct telephone interviews to determine subject eligibility.
- Schedule intake appointment to recruit subjects to study.
- Obtain informed consent and HIPAA authorization, conduct intake interviews, and enroll subjects.
- Maintain source documents and regulatory documentation of clinical trials.
- Ensure quality of data on CRFs.
- Monitor health and safety of subjects with frequent contact and ensure subject compliance with the study protocol.
- Present adverse event documentation to Principal Investigator and sponsor where appropriate.
- Train, supervise and evaluate clinical research coordinators and research assistants in the performance of their duties.
- Update training module and retrain study staff as required.
- Create and maintain a database of subject information and generate reports and shipments of data to the coordinating center, as needed.
Clinical Research Coordinator
Skyline Urology
10.2014 - 11.2014
- Conducted day-to-day execution of clinical research protocols including obtaining informed consent, completing study procedures, and dispensing, accounting for study drugs, and documenting drug compliance.
- Responsible for recruiting prospective research subjects for clinical trials.
- Responsible for clinical communication with central and local IRBs and maintaining ethical approval for studies, from initial study approval through study amendments, annual continuations, and finally termination.
- Documented and conducted appropriate correspondence regarding adverse events, including multiple severe adverse events.
- Responsible for clinical tasks including venipuncture, vital signs, body measurements and ECG.
- Working with contracts and budgets with study sponsors from study start-up through study close-out.
- Track CRFs, perform data review/validation and query resolution as needed.
- Collect, verify, organize and record phase I oncology clinical trial data on CRFs (Case report forms), and into electronic case report form databases.
- Act as liaison with study sponsors, CROs and contract clinical research monitors.
- Reconciliation of serious adverse events and adverse events for proper terminology and coding of adverse events.
- Track study progress and conduct weekly study status meetings.
- Identify data management project issues and provide assistance to ensure that study deadlines are met.
- Assist in mentoring and training of data management staff members on data management procedures, data entry and use of different database systems.
- Represent data management department at study initiation visits and business development meetings.
- Assist regulatory with processing of WIRB approvals and documentation and all other clinical documents that need to be in the sponsor's regulatory binders.
Clinical Research, Coordinator ll
Coastal Integrative Cancer Care
02.2014 - 06.2014
- Managed several study protocols at one time.
- Conduct evaluation, initiation, and routine monitoring and close out visits at each assigned study site.
- Subject Recruitment/Consultation – Communicate and review the study-specific benefits and risks with potential study subjects prior to their participation in a research study.
- Subject Study Visits - Ensures accurate completion of all study-specific procedures and data capture requirements at the time of the subject study visit.
- Data Capture - Ensures accurate recording and transcription of subject related information.
- In study source documentation.
- Study Related Communication - Communicates as needed with study subjects regarding their participation in the specific research study.
- Query Resolution – Aids in the completion of study-specific queries and data correction forms with the data management team.
- SAE Reporting – Ensures appropriate recording and reporting of subject serious adverse events by regulatory management.
- Monitoring Visits – Prepares and facilitates the completion of study initiation and regular, interim monitoring visits.
- Drug Accountability – Ensuring the accuracy of compliance to study drug administration by subject.
- Study Training – Participate in the regular training of study-specific research protocols by site medical and research directors, as well as ensure the regular and maintained training of all research support personnel.
- As required, attend off-site sponsor-endorsed study-specific training meetings.
- Investigator Relations –Ensure the accurate communication with study investigators of study-related issues, including subject-specific laboratory/procedure results, changes in research protocols, etc.
- Vendor Communication – Communicate regularly with representatives from all study-related vendors, assisted in updating study trackers and ensured accuracy against clinical databases and effectively interacted with team members to drive project goals.
Clinical Research Coordinator
Family Medical Center Foothills
07.2013 - 01.2014
- Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal.
- Write updates and reviews and approves all required trial data management documentation, also Monitors the progress of all data management activities for the project to ensure that project timelines are met.
- Conducted day-to-day execution of clinical research protocols including obtaining informed consent, completing study procedures, and dispensing, accounting for study drug, and documenting drug compliance.
- Responsible for recruiting prospective research subjects for clinical trials.
- Responsible for clinical communication with central and local IRBs and maintaining ethical approval for studies, from initial study approval through study amendments, annual continuations, and finally termination.
- Documented and conducted appropriate correspondence regarding adverse events, including multiple severe adverse events.
- Responsible for clinical tasks including venipuncture, vital signs, body measurements and ECG.
Clinical Research Coordinator
American Neuropsychiatric Research Institute Inc
02.2012 - 06.2013
- Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal.
- Writes updates and reviews and approves all required trial data management documentation, documents also Monitor the progress of all data management activities for the project to ensure that project timelines are met.
- Performs investigative site file reconciliation, requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
- Participate in preparation and management of research budgets and monetary disbursements.
- Inform patients or caregivers about study aspects and outcomes to be expected.
- Code, evaluate, or interpret collected study data.
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
- Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Communicate with laboratories or investigators regarding laboratory findings.
- Performs source document verification, retrieves case report forms (CRFs) and performs query resolution in a timely manner and oversees drug.
- Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews.
- SAE information, resolves queries and assists sites in completion of SAE reports.
- Identifying and resolving site performance issues related to protocol/GCP compliance, subject recruitment and/or data capture and retrieval, Updates and other documents as required.
- Analyze and evaluate clinical data including Case Report Forms (CRF) and source documents, to ensure subject safety, investigator compliance, and site adherence with the study drug protocol, overall clinical objectives, and FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.
- Prepare, review, follow-up, and report on Adverse Events (AE)/Severe Adverse Events (SAE) reports.
- Acquire specific clinical and therapeutic knowledge related to studies monitored.
- Ensure complete and thorough study drug accountability and reconciliation.
- Manage trip reports, letters, query resolutions and expenses.
Education
Doctor of Pharmacy -
American University of Health Sciences
Signal Hill, CA01.2023
MBA -
Schiller International University
Largo, FL01.2012
Bachelor of Science - Biochemistry
University of UYO
AK01.2008
Skills
- Processing individual case safety reports
- MedDRA coding
- Periodic safety report preparation
- Adverse event management
- Data clarification
- Pharmacovigilance regulations knowledge
- Safety database experience
- Causality assessment
- Seriousness determination
- Quality assurance in case processing
- ICSR narrative generation
- Regulatory team collaboration
- Medical team collaboration
- Therapeutic expertise in endocrinology
- Therapeutic expertise in dermatology
- Therapeutic expertise in oncology/hematology
- Therapeutic expertise in allergy/pulmonology
- Therapeutic expertise in orthopedics
- Therapeutic expertise in infectious diseases
- Therapeutic expertise in ophthalmology
Affiliations
- ACRP-Association of Clinical Research Professionals
- SOCRA-Society for clinical research Association, 50210
- National Black MBA Association, Los Angeles Chapter
- BNET - Business Network
- UN-United Nations
Certification
- Advanced Drug Safety and Pharmacovigilance certification
- Advance International Pharmacovigilance and Argus Safety Certification (APVASC)
- Certificate in Good Clinical Practice
- Certificate in IATA Training
- Certificate in Medical Terminology (EKG Monitor Technician Certification)
- Phlebotomy (Phlebotomy Certification)
References
Available upon request.
Timeline
Drug Safety Specialist
Medi Pharm Solutions
08.2025 - Current
Clinical Research Monitor
ONCOtherapeutics
06.2024 - 02.2026
Clinical Research Program Assistant (Quality Assurance) (Contract)
The Angeles Clinic Research and Institute Affiliate-Cedars Sinai
03.2024 - 06.2024
Snr. Clinical Research Associate
Providence Saint Joseph Medical Center
02.2016 - 06.2020
Clinical Research Coordinator III
Southern California Oncology Research Alliance
03.2015 - 02.2016
Clinical Research Coordinator
Skyline Urology
10.2014 - 11.2014
Clinical Research, Coordinator ll
Coastal Integrative Cancer Care
02.2014 - 06.2014
Clinical Research Coordinator
Family Medical Center Foothills
07.2013 - 01.2014
Clinical Research Coordinator
American Neuropsychiatric Research Institute Inc
02.2012 - 06.2013
Doctor of Pharmacy -
American University of Health Sciences
MBA -
Schiller International University
Bachelor of Science - Biochemistry
University of UYO