NATASHA TETTEY
Atlanta,GA
Summary
Detail-oriented Clinical Research Associate well-versed in evaluating sites, initiating trials, and managing closeouts. Experienced in Phase I, II, III and IV trials and successful at adapting to new processes, bringing excellent organizational, planning, and interpersonal skills gained during 9-year career.
Overview
13
13
years of professional experience
Work History
Senior Clinical Research Associate
Advanced Clinical
11.2021 - Current
- Participate in the investigator’s selection/feasibility
- Participate in investigator meetings and assists in the preparation of these meetings when required
- Manage my own visit schedule in accordance with the study needs and the clinical monitoring plan
- Write and send confirmation letter to site staff
- Travel to research sites as required
- Act as the Lead CRA on a project
- Review and/or input to study protocol, CRF and Validation tools
- Preparation and/or review any kind of study documents, Monitoring Guidelines, CRF Completion Guidelines, Patient Information, and Informed Consent Form etc
- Prepare the submission to the Independent Ethics Committees (central and local) and when applicable to competent/regulatory authorities
- Assist in developing of Investigator and Institution contracts and budget template, negotiate budgets with sites and arrange site payments
- Prepare and finalize monitoring visit reports (MVRs) and the site visit follow-up letter (FFUL) as outlined in the Monitoring Plan
- Review the Investigator Site File (ISF) and the Pharmacy Binder (if applicable) for accuracy, timeliness, and completeness
- Review the Trial Master File (TMF) and ensures that all documents are in order, logical, accurate, complete, and up to date
- Verify that all delegation study staff are suitably trained/certified and maintain compliance with requirements of study protocol, informed consent process, data collection requirements, Investigational Product/Investigational Medical Device (IP/IMP) accountability/supply management, and safety reporting requirements
- Conduct site monitoring visits as assigned/required: qualification (pre-study), site initiation, routine (interim) and close-out
- Responsible for multiple projects, in a country specific or global range, and able to work both independently and in a team environment
- Train site teams on therapeutic domains, protocol adherence, correct documentation, and case report form completion.
- Manage and record the distribution and return of trial materials at each site.
- Oversee and document the distribution, stock, and reconciliation of trial products.
- Supervise and document the storage and transportation of lab samples.
- Address data queries and collaborate with trial sites to rectify data inconsistencies.
- Ensure regulatory documents are accurate and comprehensive, and assist trial sites with regulatory challenges.
- Keep detailed and updated study records, reviewing them to guarantee all necessary documentation is in place.
- Regularly communicate with trial sites, investigators, coordinators, client teams, and others involved in the clinical trials.
- Act as a go-to for the project team, assisting CRA I and CRA II personnel by offering solutions to challenges.
Senior Clinical Research Associate
Clintec International
01.2019 - 10.2021
- Assisted with data query form (incl
- Query process)
- Provided up to date information and proactive communication with project teams on all subjects
- And site matters
- Collaborated with applicable departments and project teams to ensure documentation meets study needs
- Developed and implemented corrective actions when appropriate
- Prepared /reviewed all patients tracking records
- Input and maintained study information concerning subject status of financial reimbursement to sites
- Conducted on the job training and formal training to other CRAs and Clinical Trials Assistants
- Collaborated with Regional Monitoring Manager or Clinical Operations Manager /study teams to resolve site issues
- Conducted and assisted with administrative activities as a member of the project team
- Participated in routine study progress meetings, face to face or via teleconference
- Performed Co-monitoring visits to meet DBL timelines
- Directed team meetings by providing consistent reporting and updates to all applicable team members and management
- Ensured site visits are conducted according to study budget
- Reviewed study visit reports, follow-up letters and site communication generated by other CRAs for
- Timeliness, quality, consistency, and appropriate documentation and resolution of issues, with
- Support from Clinical Team Lead, Regional Monitoring Manager or Clinical Operations Manager as needed
- Provided overall clinical project manager oversight on multi-department studies
- Performed management of study site activities to ensure the integrity of clinical data, in adherence
- To protocol, all applicable regulatory guidelines, and Standard Operating Procedures (SOPs).
CRA II - Senior Clinical Research Associate
Syneos Health, Home Based
12.2014 - 01.2019
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork
- Performed pre-study, closeout, and interim visits to check on study activities
- Assessed drug storage conditions and procedures to check adherence to standard protocols
- Evaluated proof of eligibility and consent for participants
- Checked electronic data capturing systems for integrity and compliance
- Identified issues at sites; resolved issues and escalated as appropriate
- Participated from audit organization and inspection readiness activities for monitoring and site related activities as required and ensured implementation of corrective actions within specified timelines
- Conducted feasibility and screened potential Investigators and networks to evaluate capabilities for conducting clinical trials
- Contributed to the development and review of protocols, study tools, and materials as well as documentation for clinical trials
- Provided mentoring, training, and co-monitoring of junior clinical team members
- Developed and maintained effective working relationships with clinical sites
- Reviewed supplies and assist site with ordering additional supplies as needed
- Discussed recruitment progress, issues, and plans to mitigate hurdles and drive enrollment to success
- Maintained study specific tracking via CTMS or other tools
- Assisted with protocol and CRF review
- Conducted study feasibility and site selection activities
- Assisted with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials
- Developed and implemented innovative approaches for and participated in site recruitment, selection, and initiation activities
- Assisted with investigator meeting activities including organization, preparation, and attendance.
Clinical Research Associate I
Parexel International
08.2012 - 12.2014
- Performed all types of site monitoring visits including Pre-study visits, Initiation visits, Interim Monitoring Visits, and closeout visits
- Worked with sites to establish a robust site recruitment plans and track progress towards the accomplishment of recruitment targets
- Completed visit reports after each visit in accordance with monitoring plans
- Site study start up activities including budgeting, contract development and negotiations, site initiation visits, and GCP Instruction to Investigators/Research Personnel
- Played active role in the training of site personnel during Investigator Meetings
- Ongoing monitor visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication
- Worked with sites to troubleshoot and resolve issues at the site
- Training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists
- Monitored drug inventory, dispensing, compliance and return and ensure that used and expired medication are returned to the sponsor or disposed per pharmacy guidelines
- Tracked and reported site enrollment, progress, and work with sites to brainstorm on new recruitment strategies to ensure that recruitment targets are met.
Clinical Trial Assistant
Parexel International
05.2010 - 08.2012
- Ensured vendor PO contains funds for insurance and translation vendors
- Assisted in any purchase order (PO) related inquiries
- Reconciliation & management of key documents (plans, site contact list, etc.)
- Facilitated the initiation and maintenance of the Clinical Trial Agreements, contract execution, vendor purchase orders
- Assisted with Clinical Operations internal filing of study documents
- Provided continuous input to electronic Trial Master File (eTMF) content list
- Conducted comprehensive review, as per Trial Master File (TMF) Plan
Education
Bachelor of Science - Psychology
Kennesaw State University
Marietta, GASkills
Therapeutic Areas
- Rare Disease: Ichthyosis, Cystic Fibrosis and Sickle Cell Disease
- Dermatology: Glabellar Lines, Acne Vulgaris
- Infectious Disease: Herpes, Flu, Vaccine
- Women’s health: Bacterial Vaginitis (BV), Vaginal Atrophy
- Oncology- Solid Tumor, Cachexia, Brain Cancer
- Ophthalmology: Glaucoma, Dry Eye
- Medical Device: In Vitro Diagnostics, Heart Stents
Skills
- Great communication and interpersonal skills
- Excellent flexibility
- Ability to adapt to change quickly
- Ability to travel nationwide 75 - 80% of the time
- Knowledge of ICH and GCP process
- Excellent Organization and Multitasking Skills
- Worked in Phase I, II, III and IV of clinical trials
Timeline
Senior Clinical Research Associate
Advanced Clinical
11.2021 - Current
Senior Clinical Research Associate
Clintec International
01.2019 - 10.2021
CRA II - Senior Clinical Research Associate
Syneos Health, Home Based
12.2014 - 01.2019
Clinical Research Associate I
Parexel International
08.2012 - 12.2014
Clinical Trial Assistant
Parexel International
05.2010 - 08.2012
Bachelor of Science - Psychology
Kennesaw State University
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