Miranda Ndichafah
Wilmington,NC
Summary
Knowledgeable Research Project Manager experienced in onsite and remote monitoring with a strong background in conducting feasibility studies and overseeing the start-up and management of research projects. Seeking to leverage expertise in project management, operational coordination, and team leadership to drive the success of research initiatives at New Hanover Regional Medical Center. Ensures trial sites are compliant with protocol requirements and the data captured is accurate by performing case report form review, query generation and resolution. Efficient in maintaining patient safety, regulatory compliance, and data integrity.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Certified Medical Assistant
Novant Health, Inc
05.2023 - Current
- Initiated and executed a plan of care based on patient assessments
- Collected pertinent information from patient, family, medical records and prescriptions regarding patient's present and past medical history
- Completed detailed patient care reports with supporting required documentation.
- Excellent use of EPIC and medical records
- Maintained positive working relationships with other emergency personnel such as nurses, doctors, and patient families
- Facilitated ongoing communication among team members to relay timelines, identify potential issues, and problem-solve as needed, providing regular updates on procedure scheduling
Certified Medical Assistant/Senior Research Associate
Tuality Community Hospital
04.2018 - 03.2023
- Monitored site performance and implemented action plans for sites not meeting expectation, in conjunction with the lead CRA
- Performed Case Report review, query generation and resolution against established data review guidelines
- Assisted with the coordination of study visits and shipment of drug and laboratory samples
- Served as contact for project team and investigative sites
- Assisted lead CRAs with preparation for site visits (i.e. running reports, QC of files, resolving action items from previous visits)
- Managed sites to ensure subjects are complying with protocol requirements, study visits, and timelines
- Liaised with the project team and others to distribute and track clinical trial supplies e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment
- Worked in a timely manner in accordance with all the activities specified in the agreed study budget
- Ensured ancillary departments involved in research projects were educated and prepared to conduct studies, providing training as necessary.
- Oversaw research builds in EPIC and other systems, tracked study progress, and provided reports as needed.
- Performed visits either as the primary monitor or as the co-monitor as required by the monitoring plan
Certified Medical Assistant/Research Intern
The Portland Clinic
04.2017 - 06.2018
- Assisted in the preparation of study site specific materials in accordance with relevant SOPs(Standard Operating Procedures)
- Ensured site correspondence was filed for Sponsor review
- Assisted CRAs with preparation for site visits (i.e. running reports, QC(Quality Control) of files (checking for missing documents), resolving action items from previous visits)
- Provided query summary reports to sites to ensure resolution in a timely manner.
- Maintained the electronic records using EPIC
- Prepared and sent study materials to investigator sites
- Attended study meetings and arranging investigator meeting arrangements
- Sanitized, restocked, and organized exam rooms and medical equipment.
- Provided compassionate care for patients, addressing their concerns and ensuring a positive experience.
- Assisted physicians with various procedures, ensuring comfort and accuracy for optimal patient outcomes.
Clinical Research Associate
General Hospital Bamenda
01.2010 - 09.2014
- Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Coordinated and managed all operational and technical aspects of research projects, including internal collaborations and interactions with study sponsors.
- Collaborated with Principal Investigators, study coordinators, finance coordinators, and other departmental leaders to prioritize research projects and ensure operational and financial feasibility.
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Build awareness of features and opportunities of study to site.
- Collaborate and liaise with study team members for project execution support as appropriate.
Education
Bachelor of Science - Business Administration
University of North Carolina Greensboro
Greensboro, NC05.2025
Associate of Science - Business Administration And Management
Central Community College
Grand Island, Nebraska 05.2021
Associate of Science - Health Administration
University of Bamenda
Bamenda, Cameroon12.2012
Skills
- Proficient in project management software, Clinical Trials Management Systems, and Electronic Data Capture software(Research Manager)
- Strong knowledge of clinical trial operations, including complex studies
- Excellent team leadership and interpersonal skills, with the ability to collaborate effectively across departments
- Proficient in Microsoft Excel and other computer applications
- Flexible and adaptable, with a willingness to learn new procedures and technologies
- Project management and data analysis expert with a nose for removing impediments
Certification
- Project Management Professional - Project Management Institute
- Certified Medical Assistant (CMA) NCCT
- Medical Terminologist Certificate
- Active CPR American Heart Association
- Certified Scrum Master - Scrum Alliance
- Professional Scrum Master – Scrum.Org
- Certified Collective Capabilities – Enterprise Agility University
- Certified Change Consultant – Enterprise Agility University
- Certified Jira – Atlassian University
Timeline
Certified Medical Assistant
Novant Health, Inc
05.2023 - Current
Certified Medical Assistant/Senior Research Associate
Tuality Community Hospital
04.2018 - 03.2023
Certified Medical Assistant/Research Intern
The Portland Clinic
04.2017 - 06.2018
Clinical Research Associate
General Hospital Bamenda
01.2010 - 09.2014
Bachelor of Science - Business Administration
University of North Carolina Greensboro
Associate of Science - Business Administration And Management
Central Community College
Associate of Science - Health Administration
University of Bamenda