Esther Eke
Atlanta,Georgia
Summary
Senior Clinical Research Associate with experience in the management and monitoring of clinical trial sites. Proficient in study start-up, maintenance, and close-out procedures. Recognized for building strong relationships with study sites, improving site performance and quality, and maintaining documentation per timelines. Good communicator, attentive to details, and result oriented. Eager to contribute to the success of the clinical research mission.
Overview
14
14
years of professional experience
Work History
Senior Clinical Research Associate
Zydus Pharmaceuticals (Richellieu)
11.2020 - Current
- Assist in the conduct of site qualification visits SQV, site initiation visits, SIV, interim monitoring visits IMV, and site close out visits, COV, in accordance with SOPs, ICH/GCP
- Coordinates between in-house team, site, vendor, CRO and appropriate contacts to ensure sites are equipped with all necessary supplies to perform study procedure
- Ensures all project specific training is conducted and documented for the site throughout the life of the trial
- Review of any kind of study documents, Monitoring Guidelines, CRF Completion Guidelines, Patient Information, and Informed Consent Form etc
- Coordinates between site and applicable parties to ensure sites have all applicable study required accesses
- Ensures all site staff requests are responded to effectively
- Writes visit reports and corresponding site visit confirmation and follow-up correspondence for all site visit types
- Ensure data quality of assigned sites, by performing source document verification, source data review, review regulatory documents and investigational product, and prepare trip reports as outlined in the Monitoring Plan
- Responsible for follow-up and resolution of the site questions, issues, concerns, including but not limited to protocol questions, visit follow-up items, queries, action items and protocol deviations
- Ensures site visits are scheduled and conducted in accordance with the Clinical Monitoring Plan (schedule and activities)
- Responsible for maintaining relationships with and serving as single point of contact for communications with all sites including the Principal Investigator, sub-Investigations, Study Coordinators, Pharmacist(s), and Laboratory Personnel
- Proactively support contract and budget negotiations and payment processes, as required
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness
- Reconciles the ISF with the Trial Master File (TMF) to ensure audit readiness, including filing of all applicable documents, and supports site audit and inspection activities as needed.
Clinical Research Associate ll
Richellieu
10.2017 - 11.2020
- Conducted completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits to determine protocol and regulatory compliance
- Performed and documented pre-study evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company SOPs, applicable regulatory requirements and defined quality and performance standards
- Provided site management and monitoring support for sponsored clinical studies phase I, II, and III Assisted in the training and mentoring of junior CRAs
- Identified and escalated issues, participating in problem-solving and risk mitigation strategies
- Coordinated and maintained tracking systems for subject screening, enrollment, study visits, data entry, query resolution, and related metrics
- Conducted co-monitoring visits with CRO during site qualification, initiation, routine monitoring, and close-out visits
- Contributed to the development, review, and implementation of departmental SOPs and processes
- Assisted in the development of study-related clinical documents, including informed consent forms, site training materials, CRFs, clinical monitoring plans, and source document templates
- Oversaw contract vendors and CRO activities, ensuring adherence to study plans, timelines, budgets, SOPs, and compliance with GCPs, FDA regulations, and ICH/GCP guidelines
- Supported the preparation of study protocols, Investigator’s Brochures (IBs), and regulatory submissions
- Promoted a quality-focused work environment, fostering learning, respect, open communication, collaboration, integration, and teamwork
- Collaborated with Clinical Operations study leads to support all aspects of clinical studies from initiation to close-out
- Led site and study/vendor management activities, including ICF development/review, site activations, monitoring reports, and study plans
- Acted as a liaison between sponsor and Investigators/study sites, strengthening sponsor-site relationships.
Clinical Research Associate I
Richellieu
08.2015 - 09.2017
- Developed strong site relationships and ensured continuity of site relationships through all phases of the trial
- Performed clinical study site management/monitoring activities in compliance with ICH GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents
- Gained an in-depth understanding of the study protocol and related procedures
- Coordinated & managed various tasks in collaboration with other sponsor roles to achieve Site Readiness
- Participated & provided inputs on site selection and validation activities
- Performed remote and on-site monitoring & oversight activities using various tools to ensure data generated at site is complete, accurate and unbiased, ensuring subjects’ rights, safety and well-being are protected
- Conducted site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
- Collected, reviewed, and monitored required regulatory documentation for study start-up, study maintenance and study close-out
- Communicated with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
- Developed and maintained good working relationships with investigator and study staff
- Performed data management activities, including in-house CRF review, query resolution, and resolved data discrepancies
- Assisted with IP accountability and proper maintenance of IP processes and documentation at the site.
Clinical Research Coordinator
Southeast Missouri Health
12.2013 - 07.2015
- Screened patient records, database, and physician referrals to identify prospective candidates for research studies
- Collected data and followed research protocols, operations manuals, and case report form requirements
- Developed and maintained basic competencies required to conduct clinical research including maintaining current training record
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Followed informed consent processes and maintained records
- Screened potential patients for protocol eligibility
- Presents trial concepts and details to the patients, participated in the informed consent process, and enrolled patients on clinical trials
- Assisted with patient care in compliance with protocol requirements
- Participated in required training and education programs as well as monitoring and auditing activities
- Assisted with scheduling monitoring and auditing visits, as well as interacting with the monitors/auditors while onsite
- Assisted the site with collection and maintenance of regulatory documents in accordance with the site SOPs and applicable regulations
- Involved in the packing and shipping of lab specimens to central vendors
- Maintained compliance with protocols covering patient care and clinical trial operations.
Certified Medication Tech
Edward Memory Care Facility
07.2010 - 09.2013
- Coordinated daily medicine schedules and administration to help patients address symptoms and enhance quality of life
- Took patients vital signs, height and weight measurements and monitored glucose and patient wellbeing
- Kept digital records of patient’s details, medications, billing, and other activities
- Administered prescribed drugs to high-volume patient caseload
- Offered support for patients mental and emotional needs to enhance physical outcomes and overall happiness
- Administered medications to patients and remained vigilant for negative side effects
- Kept close eye on behavior and emotional responses of patients, consulting with Management to address concerns and protect each person from any harm
- Checked vital signs daily and contacted RN regarding any patient health concerns or behavioral changes
- Encouraged patients to participate in safe physical activity to help boost mood and improve overall wellness
- Interacted kindly with patients and families and displayed a positive, outgoing attitude, resulting in establishment of long-term, professional relationships
- Reduced risks of patient infection and cross-contamination by cleaning and sterilizing equipment
- Collaborated with peers and attended weekly meetings to brainstorm new activities for patients and discuss ways to resolve issues.
Education
Bachelor of Science (B.S.) - Mass Communication: Public relations
Southeast Missouri State University
01.2017
Bachelor of Science (B.S.) - Biology: Zoology
Madonna University
01.2009
Skills
- Interpersonal and strong communication and Interpersonal skills, both verbal and written
- Phase I-III clinical trial experience
- Excellent knowledge of FDA and ICH/ GCP Regulations and guidelines
- Team oriented, and ability to work independently Great attention to detail and critical thinking
- Data Management and Document Management
- Good time management and ability to prioritize tasks and accomplish set goals efficiently
- Ability to travel domestically and internationally
- Strong problem-solving skills Organized, and able to work under pressure and meet deadlines
- Clinical Trial Management, vendor Management
- Regulatory Compliance (GCP, FDA, ICH/GCP)
- Site Coordination, risk Mitigation, clinical documentation
- Data Management, strong Communication Skills, Problem Solving, team collaboration
Therapeuticareas
- Ophthalmology: Age Related Macular Degeneration and Glaucoma
- Neurodegenerative Disorders ALS
- Medical Device: In Vitro Diagnostics
- Oncology: Solid Tumor, Breast cancer, Brain Tumor, Colon Cancer, Lung Cancer, HGG
- Respiratory: Asthma, lung disease
- Infectious Disease: HIV, COVID-19
- Cardiovascular: Heart failure
Systems
- EDC: DataLab, Inform, Medidata Rave, Medrio.
- CTMS: Impact, Infolink 2, Veeva Vault
- ETMF: Veeva Vault, Wingspan
- Electronic Medical Records (EMR): EPIC, Cerner, eClinicalWorks, NextGen Healthcare
- Proficiency in Microsoft Word, SharePoint, PowerPoint and Excel.
Timeline
Senior Clinical Research Associate
Zydus Pharmaceuticals (Richellieu)
11.2020 - Current
Clinical Research Associate ll
Richellieu
10.2017 - 11.2020
Clinical Research Associate I
Richellieu
08.2015 - 09.2017
Clinical Research Coordinator
Southeast Missouri Health
12.2013 - 07.2015
Certified Medication Tech
Edward Memory Care Facility
07.2010 - 09.2013
Bachelor of Science (B.S.) - Mass Communication: Public relations
Southeast Missouri State University
Bachelor of Science (B.S.) - Biology: Zoology
Madonna University
Similar Profiles
Cecilia Avilés HernándezCecilia Avilés Hernández
Key Account Manager at Zydus PharmaceuticalsKey Account Manager at Zydus Pharmaceuticals
ANKIT SHUKLAANKIT SHUKLA
Senior Executive at Zydus Pharmaceuticals LimitedSenior Executive at Zydus Pharmaceuticals Limited
Mitali K SolankiMitali K Solanki
Research Intern at Zydus Cadila PharmaceuticalsResearch Intern at Zydus Cadila Pharmaceuticals