Henrietta T. Baah
Cheltenham,PA
Summary
Seasoned Senior/Lead Clinical Research Associate with background in managing and overseeing clinical trials. Strengths include thorough knowledge of clinical trial protocols, patient recruitment and retention, data management, and regulatory compliance. Previous roles have demonstrated strong leadership skills, efficiency in monitoring activities related to clinical studies, and ability to maintain high-quality standards for all research projects. Proven track record of significant contributions towards improving processes and streamlining workflow within previous organizations.
Overview
9
9
years of professional experience
Work History
Senior Clinical Research Associate II/ Lead Clinical Research Associate
Fortrea (Formerly LabCorp Drug Development)
Philadelphia, PA
10.2021 - 03.2025
- Executed all phases of clinical site monitoring including selection, initiation, and close-out activities.
- Identified an experienced investigator through careful assessment to oversee the conduct of the trial at the trial site. Ensured compliance with monitoring protocols while managing vendor interactions effectively.
- Supported quality control program by scheduling site assessment visits for project and conducting monitoring visits.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Prepared reports summarizing study progress and results for senior management review.
- Ensured proper storage of investigational product at investigator sites per GCP guidelines.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Maintained regulatory readiness at the site level through constant preparedness measures.
- Verified informed consent procedures were followed to protect participant safety.
- Conducted comprehensive reviews and verifications of source documents to affirm data integrity.
- Developed specific monitoring tools aimed at improving data accuracy during trials.
- Analyzed study data and prepared reports for research team discussions.
- Provided training and mentorship to junior CRAs on study systems, protocols, and processes.
- Conducted quality visits with CRAs.
- Accompanied CRAs for co-monitoring.
- Delegated tasks to CRAs as required.
- Coached team members on best practices for conducting effective studies.
- Attended meetings and reported on activities and resolutions.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Participated in internal audits related to clinical research operations processes.
- Reported to project manager for issues related to overall study status.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
- Checked electronic data capturing systems for integrity and compliance.
Senior Clinical Research Associate I
LabCorp Drug Development (Formerly Covance)
Philadelphia, PA
04.2021 - 10.2021
- Executed all phases of clinical site monitoring including selection, initiation, and close-out activities.
- Identified an experienced investigator through careful assessment to oversee the conduct of the trial at the trial site. Ensured compliance with monitoring protocols while managing vendor interactions effectively.
- Supported quality control program by scheduling site assessment visits for project and conducting monitoring visits.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Prepared reports summarizing study progress and results for senior management review.
- Ensured proper storage of investigational product at investigator sites per GCP guidelines.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Maintained regulatory readiness at the site level through constant preparedness measures.
- Verified informed consent procedures were followed to protect participant safety.
- Conducted comprehensive reviews and verifications of source documents to affirm data integrity.
- Developed specific monitoring tools aimed at improving data accuracy during trials.
- Analyzed study data and prepared reports for research team discussions.
- Provided training and mentorship to junior CRAs on study systems, protocols, and processes.
- Accompanied CRAs for co-monitoring.
- Coached team members on best practices for conducting effective studies.
- Attended meetings and reported on activities and resolutions.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Participated in internal audits related to clinical research operations processes.
- Reported to project manager for issues related to overall study status.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
- Checked electronic data capturing systems for integrity and compliance.
- Conducted 10 to 16 monthly site visits.
Clinical Research Associate II
Covance Clinical Research
Philadelphia, PA
09.2019 - 04.2021
- Executed comprehensive study site monitoring, ensuring adherence to protocols and regulatory compliance.
- Conducted 10 to 15 site visits monthly, managing routine monitoring and clinical site close-out processes.
- Established strong communication with vendors and sponsor representatives to facilitate project progress.
- Verified informed consent procedures to protect study participants and maintain ethical standards.
- Reviewed source documents meticulously, ensuring data integrity in Case Report Forms (CRFs).
- Monitored for missing or implausible data, issuing queries to site staff until resolution.
- Tracked Serious Adverse Event (SAE) reporting, overseeing timely production of reports.
- Optimized travel expense management, adhering to policies while performing monitoring tasks efficiently.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Achieved project-specific quality and performance standards and provided documentation and communication.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
Clinical Research Associate II
ICON
Philadelphia, PA
09.2018 - 08.2019
- Liaised with vendors and sponsor representatives.
- Performed all aspects of site management as prescribed in the site monitoring plan.
- Achieved project-specific quality and performance standards and provided documentation and communication.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Checked electronic data capturing systems for integrity and compliance.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Supported investigator selection and qualification process by offering professional input.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Spearheaded qualification, initiation, monitoring and close out visits by coordinating with project management team.
- I wrote and met trip report metrics at 100%.
- Ensured audit readiness at the site level.
- Ensured that the study staff who were conducting the protocol received the proper materials and instructions to safely enroll subjects in the study.
- Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements were adhered to according to the applicable regulatory requirements.
- Performed a careful review and verification of source documents, and ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools.
- Monitored data for missing or implausible data.
- Issued and followed up on queries with the study site staff until resolved.
- Tracked and followed up on Serious Adverse Event (SAE) reporting, and the production of reports.
- Recruited potential investigators for new studies.
- Organized meetings and other tasks as instructed by the supervisor, as assigned.
- Made all travel arrangements to sites and investigational meetings.
- Ensured timely completion of all deliverables by tracking project timelines and milestones at 100%.
- Managed inventory and supplies to ensure materials were available when needed.
Clinical Research Associate I
ICON
Philadelphia, PA
09.2016 - 08.2018
- Liaised with vendors and sponsor representatives.
- Performed all aspects of site management as prescribed in the site monitoring plan.
- Achieved project-specific quality and performance standards and provided documentation and communication.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Checked electronic data capturing systems for integrity and compliance.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Supported investigator selection and qualification process by offering professional input.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Spearheaded qualification, initiation, monitoring and close out visits by coordinating with project management team.
- I wrote and met trip report metrics at 100%.
- Ensured audit readiness at the site level.
- Ensured that the study staff who were conducting the protocol received the proper materials and instructions to safely enroll subjects in the study.
- Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements were adhered to according to the applicable regulatory requirements.
- Performed a careful review and verification of source documents, and ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools.
- Monitored data for missing or implausible data.
- Issued and followed up on queries with the study site staff until resolved.
- Tracked and followed up on Serious Adverse Event (SAE) reporting, and the production of reports.
- Recruited potential investigators for new studies.
- Organized meetings and other tasks as instructed by the supervisor, as assigned.
- Made all travel arrangements to sites and investigational meetings.
- Ensured timely completion of all deliverables by tracking project timelines and milestones at 100%.
- Managed inventory and supplies to ensure materials were available when needed.
Education
Bachelor of Science - Health Sciences
Temple University
Philadelphia, PA05.2016
Skills
Regulatory compliance readiness
- Training for teams
- Building relationships effectively
- Techniques for quality assurance
- Listening actively with clear communication
- Research in medicine and clinical settings
- Detail-oriented organization skills
- Reporting on safety measures
- Monitoring clinical trials efficiently
- Management of projects with strategic planning
- Integrity in data handling and management skills
- Managing vendor relationships collaboratively
- Resolving problems with queries effectively
- Collecting clinical data using EDC systems
- Developing drugs through clinical processes
References
Available upon request
Technology And Systems Experience
- Extensive experience with Microsoft Suite
- Revolution
- QuickBooks
- Clinical Trials CTMS systems
- Oracle Clinical
- Medidata Rave
- Trial Master File
- Axiom Fusion
- Veeva Vault
- InForm
- Medrio EDC
- Castor
- REDCap
- Office Mate
Therapeutic Experience
- Oncology Head and Neck Cancer Head and Neck-Phase III
- Oncology Other Oncology Other Oncology-Phase IIa
- Oncology Solid Tumors Squamous Cell (Solid)-Phase III
- Oncology Lung Cancer NSCLC (Non-Small Cell Lung Cancer)-Phase III
- Psychiatry Psychoses Schizophrenia-Phase IIb
- Pediatric Allergy/Asthma Allergic Rhinitis Rhinitis-Phase I
- Endocrine Diabetes- Phase I-III
- Cardiovascular - Phase III
- Rare Disease Crohn's Disease - Phase I
- Rare Disease Cystic Fibrosis- Phase II
- Pulmonary/Respiratory Chronic Respiratory Disorders Moderate/Severe Asthma-Phase III
- Pulmonary/Respiratory Chronic Respiratory Disorders COPD (Chronic Obstructive Pulmonary Disease)-Phase IIb
- Pediatric Dermatology Dermatitis and Eczema Atopic Dermatitis-Phase III
- Pediatric Anaphylaxis- Phase II
- Infectious Diseases Viral Infection Hepatitis C-Phase III
- Infectious Diseases Viral Infection Flu Prevention-Phase III
- Infectious Diseases Pediatric Pneumonia Nosocomial-Phase III
- Infectious Diseases Viral Infection Coronavirus Disease (COVID-19)-Phase I
- Infectious Diseases HIV- Phase I
- Neurology Movement Disorders Parkinson's Disease-Phase I
- Neurology Alzheimer's- Phase II
- Pediatric Vaccine Varicella- Phase III
- Pediatric Rare Disease Sickle Cell Disease- Phase II
- Medical Device - Phase III
Languages
English
Native/ Bilingual
French
Limited
References
References available upon request.
Timeline
Senior Clinical Research Associate II/ Lead Clinical Research Associate
Fortrea (Formerly LabCorp Drug Development)
10.2021 - 03.2025
Senior Clinical Research Associate I
LabCorp Drug Development (Formerly Covance)
04.2021 - 10.2021
Clinical Research Associate II
Covance Clinical Research
09.2019 - 04.2021
Clinical Research Associate II
ICON
09.2018 - 08.2019
Clinical Research Associate I
ICON
09.2016 - 08.2018
Bachelor of Science - Health Sciences
Temple University
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