Ifeanyi Amaechi
CARE ACCESS
Jessup,MD
1
Certification
10
years of professional experience
Professional with experience in clinical research coordination, equipped to make significant impact in this field. Demonstrated ability to manage clinical trials, ensure compliance with protocols, and maintain accurate documentation. Strong emphasis on team collaboration, reliability, and adaptability to evolving project requirements. Proficient in patient recruitment, data collection, and regulatory submissions, with results-driven approach that ensures successful study outcomes.
Work History
Clinical Research Coordinator 1
8 Months- Review protocols and study materials, ensure all training, supplies, systems, and staff are ready, and work with investigators, managers, and sponsors to make sure the study can run smoothly and safely from day one.
- Oversee multiple studies, prioritize timelines and patient safety, maintain organized study files, manage investigational products, coordinate monitoring visits, and ensure compliance with FDA regulations and ICH guidelines.
- Help develop recruitment strategies, prescreen potential participants, actively support recruitment efforts, and maintain positive, professional relationships with participants throughout the trial.
- Obtain informed consent, perform and coordinate study visits, collect and process specimens, administer questionnaires, conduct basic clinical procedures, and monitor patients’ progress on study medication.
- Identify and document adverse events, review labs and test results for safety concerns, ensure timely investigator review, and support appropriate safety monitoring and follow-up.
- Document study data in real time, complete source and EDC entries, manage regulatory and patient records, resolve data queries, document deviations, and support regulatory reporting and audits.
Clinical Research Coordinator 1
8 Months- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH guidelines and Velocity’s SOPs.
- Coordinate, with supervision, assigned clinical trials including study start up, subject recruitment, source development review, protocol training, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events and deviations, implementing new protocol amendments and providing close out reports.
- Implement research and administrative strategies to successfully manage assigned protocols.
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
- Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries.
- Understand key timelines, endpoints, and patient population for each assigned protocol.
- Perform clinical duties (e.g. Drug preparation and administration, fibro scan, phlebotomy, ECG, lab processing) within scope.
- Create, collect and submit regulatory documents to sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
Clinical Research Coordinator
1 Year 8 Months- Participates in logistics and monitoring activities to achieve study timelines.
- Document protocol deviations and quality issues related to a study and provide reports of action taken with the clinical investigators.
- Review serious adverse events with the principal investigator and drug safety specialist to identify causal relationships with the investigational product.
- Work with the Sponsor, Project Managers, Principal Investigators to discuss study initiation, conduct and completion and any urgent study related issues that require prompt action.
- Provide prompt response to study related issues and queries raised in RAVE EDC or Elluminate.
- Coordinate with Clinical Operations Manager, Pharmacists, Nurses and Principal Investigators to ensure timely progress of clinical trials.
- Conduct clinical trial procedures and administrative tasks while adhering to ICH-GCP guidelines, study protocol, site SOPs, FDA and IEC guidelines.
- Contributes to the maintenance of good documentation processes by keeping procedure trackers, resulting in a 50% reduction in protocol deviation and enhancing overall study efficiency.
Research Associate
8 Months- Demonstrated detailed knowledge of study protocols and collaborated with staff to implement best practices, resulting in a 5% reduction in quality issues and protocol deviations.
- Quality controlled subject binders and other study related documents in preparation for interim monitor visits (IMV) and close out visits (COV).
- Ensured site performance integrity and maintained first time quality of studies been conducted by performing quality checks on study-specific and clinical site devices.
- Extracted and input data from eCRF into electronic data capture (EDC) systems, resolving both system and CRA generated queries.
- Conducted screening visits and protocol-specific participant assessments, ensuring accurate documentation of concomitant medications, adverse events, and laboratory results in compliance with Quality Management (QM) guidelines.
Unit Clerk
1 Year 4 Months- Provided exceptional customer service by demonstrating respect, courtesy, and empathy in all patient interactions.
- Coordinated efficient information flow among healthcare personnel to streamline patient care and improve communication.
- Ensured accurate and confidential filing of patient records, maintaining compliance with healthcare regulations.
- Achieved a high infection control and hand hygiene rate of 98% through effective coordination and teamwork in the ICU.
Medical Officer
6 Months- Supervised and mentored healthcare professionals, maintaining high standards resulting in a 15% improvement in patient satisfaction scores.
- Ensured compliance with healthcare regulations and safety standards, achieving 100% adherence in audits and inspections.
- Contributed clinical expertise and guided junior physicians, enhancing team performance and patient outcomes.
Medical House Officer
1 Year- Conducted thorough history taking, admission/discharge summaries, and medical report writing, reducing misdiagnosis and mistreatment by 25%.
- Maintained contemporaneous patient notes following ward rounds and examinations, ensuring accurate documentation and continuity of care.
- Collaborated with medical officers/consultants to determine optimal treatment plans, resulting in improved patient outcomes and satisfaction.
Education
Master of Science in Health Sciences (MSHS) - Clinical and Translational Research
Doctor of Medicine
Skills
Prioritization and scheduling
Adverse event reporting
Protocol design and execution
Familiarity with regulatory compliance standards
Medical language proficiency
Good clinical practices
Patient enrollment
Management of investigational products
Phlebotomy
Electronic data capture
Documentation management
Informed consent
Certification
- Advanced Drug Safety and Pharmacovigilance.
- IMedidata RAVE Clinical Research Coordinator.
- Certificate of Annual Practicing License, Nigeria.
- Good Clinical Practice and International Conference on Harmonization Certification
- Human Subject Protection Certification
Timeline
Clinical Research Coordinator 1
CARE ACCESS
10.2025 - CurrentRead More
Clinical Research Coordinator 1
VELOCITY CLINICAL RESEARCH
02.2025 - 10.2025Read More
Clinical Research Coordinator
PAREXEL INTERNATIONAL CORP
03.2023 - 11.2024Read More
Research Associate
PAREXEL INTERNATIONAL CORP
07.2022 - 03.2023Read More
Unit Clerk
HOWARD COUNTY GENERAL HOSPITAL
06.2021 - 10.2022Read More
Medical Officer
ALADIMMA COMMUNITY HOSPITAL
10.2017 - 04.2018Read More
Medical House Officer
44 NIGERIAN ARMY REFERENCE HOSPITAL
04.2016 - 04.2017Read More
DANYLO HALYTSKY LVIV NATIONAL MEDICAL UNIVERSITY
Doctor of Medicine
Read More
THE GEORGE WASHINGTON UNIVERSITY
Master of Science in Health Sciences (MSHS) from Clinical and Translational Research
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