Francesca Ericksen
Murrells Inlet,SC
Summary
Clinical research professional with extensive expertise in managing clinical trials and ensuring regulatory compliance, consistently delivering reliable results. Exceptional skills in project management, data analysis, and stakeholder engagement foster team collaboration and adaptability to evolving needs. Renowned for navigating complex protocols with precision, driving clinical studies to successful completion while maintaining the highest standards of quality and efficiency. Committed to advancing research initiatives through strategic planning and innovative problem-solving.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Trial Manager
ICON Plc
12.2025 - Current
- Facilitate collaboration among diverse teams to ensure adherence to regulatory standards during clinical trials.
- Craft and institute detailed project timelines to streamline trial execution and maximize resource utilization.
- Collaborate with principal investigator and sponsors to streamline daily trial activities and ensure adherence to research protocols.
- Manage risk mitigation in clinical trial processes through proactive identification of potential issues and implementation of corrective actions.
- Direct data management activities to improve data quality in clinical trials, focusing on data cleaning, validation, and database lock procedures.
- Facilitate clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Lead clinical study teams and trial management teams in agenda development and execution. Facilitated meetings to drive project alignment and outcomes.
- Conduct thorough reviews of monitoring visit reports to support operational excellence and regulatory adherence.
- Oversee CRA interactions and managed training, data management, and biostatistics to support regulatory compliance and clinical development objectives.
Site Management Associate II
ICON Plc
02.2022 - 12.2025
- Assists in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating and reviewing responses to site recruitment questionnaires.
- Performing Central Monitoring Risk Review (including verifying Serious Adverse Event reporting), Off Site Monitoring Visits and real time data review, review of standard quality indicators on a regular basis as defined in the scope of work.
- Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.
- Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
- Ensures timely and complete data entry by site. Performs data review inclusive of site level data review, query resolution, facilitates database closure and freezing procedures as per study plans.
- Completes essential document collection and review throughout the study lifecycle, organizes and maintains site clinical trial master file (TMF) documents, and maintains site-related data in applicable clinical systems according to procedures and guidelines.
- Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies. Escalates issues and risks as needed.
- Accomplishments: Acted as an interim CRA and performed an Interim Monitoring Visit (IMV) on 28Aug2024 for a Breast Oncology study and completed the Clinical Trial Manager Developmental Program successfully.
Clinical Research Associate
ICON Plc, Formerly PRA Health Sciences
05.2021 - 01.2022
- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely.
- Provides regular site status information to team members, trial management, and updates trial management tools.
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
- Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed.
- Performs source document verification and query resolution.
- Assesses IP accountability, dispensation, and compliance at the investigative sites.
- Performs essential document site file reconciliation.
- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines.
- Communicates with investigative sites.
- Ensures all required training is completed and documented.
- Updates applicable tracking systems.
- Serves as observation visit leader.
- Completes monitoring activity documents as required by PRA SOPs or other contractual obligations.
- Facilitates audits and audit resolution.
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines.
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
Clinical Trial Navigator Assistant
Javara
01.2021 - 05.2021
- Updated patient's chart if there is an additive or removal of a concomitant medication.
- Performed COVID-19 vaccine trial patient's vitals before and after IP administration and answered any additional questions they may have.
- Worked alongside mission control to aid in the progression of the COVID-19 vaccine trial.
- Correctly and efficiently filed source documents into patient's folder concerning COVID-19 vaccine trial.
- Utilized GCP and HIPAA practices in every task that is performed.
- Performed above and beyond the call of duty.
- Conducted ECG procedure.
- Conducted follow up calls to ensure participants safety for COVID-19 vaccine trials.
- Performed pregnancy tests for child-bearing women in trials.
- Reviewed COVID-19 vaccine trial charts for discrepancies in source documents.
Full-Time Clinical Research Intern
Javara
08.2020 - 01.2021
- Led lab operations for COVID-19 vaccine trials.
- Performed pregnancy tests for child-bearing women in trials.
- Performed COVID-19 vaccine trial patient's vitals before IP administration and answered any additional questions they may have.
- Made sure patients met all inclusion and exclusion criteria before enrolling them into trial.
- Adequately obtained informed consent form and medical history for COVID-19 vaccine trial.
- Conducted follow up calls to ensure participants safety for COVID-19 vaccine trials.
- Completed ICF (informed consent form) mitigation for validity in COVID-19 vaccine trial.
- Documented AE's and SAE's into EMR associated with COVID-19 vaccine trial patients.
- Reviewed COVID-19 vaccine trial charts for discrepancies in source documents.
- Completed illness visits (potential case of COVID-19 positive) for COVID-19 vaccine trial.
- Performed above and beyond the call of duty.
- Updated patient's chart if there is an additive or removal of a concomitant medication.
- Utilized GCP and HIPAA practices in every task that is performed.
- Shipped out both cryogenic vials and nasal swabs to designated lab for COVID-19 vaccine trial.
- Explained and made sure patients understood how to complete e-diaries for assigned projects.
- Executed centrifuging of patients' blood and aliquoting of serum.
- Scanned e-source documents and e-signed them into patients file through EMR.
- Scheduled patients for their next in person visit and safety calls for COVID-19 vaccine.
- Correctly and efficiently filed source documents into patient's folder concerning COVID-19 vaccine trial.
Education
Bachelor of Science - Clinical Research
University of North Carolina Wilmington
Wilmington, North Carolina, United States of America (the)05-2021
High School, Diploma - undefined
Phillipsburg High School
Phillipsburg, New Jersey, United States of America (the)05-2015
Skills
- Training and mentoring
- Clinical trial oversight
- Teamwork and collaboration
- Time management
- Problem-solving
- Leadership skills
- Attention to detail
- Multitasking and Prioritization
- Critical thinking
- Excellent communication
Certification
- Rave CSA Critical Fundamentals, Medidata Academy, United States of America (the) Acquired Date: 2021-04
- Medidata Rave EDC: eSignatures, Medidata Academy, United States of America (the) Acquired Date: 2020-11
- Medidata Rave EDC: Principal Investigators, Medidata Academy, United States of America (the) Acquired Date: 2020-11
- Medidata Rave EDC: Data Managers, Medidata Academy, United States of America (the) Acquired Date: 2020-11
- Medidata Rave EDC: Markings, Medidata Academy, United States of America (the) Acquired Date: 2020-10
- Medidata Rave EDC: Clinical Research Associates, Medidata Academy, United States of America (the) Acquired Date: 2020-10
- Medidata Rave EDC: Cleaning Data, Medidata Academy, United States of America (the) Acquired Date: 2020-09
- Medidata Rave EDC: Clinical Research Coordinators, Medidata Academy, United States of America (the) Acquired Date: 2020-09
- Conflict of Interest Training: Clinical Trial Navigator/Assistant Clinical Trial Navigator, CITI, United States of America (the) Acquired Date: 2020-08
- Recruitment Training, CRIO, United States of America (the) Acquired Date: 2020-08
- Good Clinical Practice Training: Clinical Trial Navigator/Assistant Clinical Trial Navigator, CITI, United States of America (the) Acquired Date: 2020-08
- Human Subject Research Training: Clinical Trial Navigator/Assistant Clinical Trial Navigator, CITI, United States of America (the) Acquired Date: 2020-08
- IATA Dangerous Goods, IATA, United States of America (the) Acquired Date: 2020-08
- ESource Training, CRIO, United States of America (the) Acquired Date: 2020-08
- Monitoring and Auditing, TransCelerate Biopharma Inc., United States of America (the) Acquired Date: 2020-04
- Adverse Events and Safety, TransCelerate Biopharma Inc., United States of America (the) Acquired Date: 2020-04
- Medidata Rave EDC: Task Management, Medidata Academy, United States of America (the) Acquired Date: 2020-03
- Medidata Rave EDC: Entering and editing data, Medidata Academy, United States of America (the) Acquired Date: 2020-03
- Medidata Rave EDC: Creating A Subject, Medidata Academy, United States of America (the) Acquired Date: 2020-03
- Medidata Rave EDC: Getting Started, Medidata Academy, United States of America (the) Acquired Date: 2020-03
- Medidata Rave EDC: Account Management, Medidata Academy, United States of America (the) Acquired Date: 2020-03
- Source Documentation, TransCelerate Biopharma Inc., United States of America (the) Acquired Date: 2020-03
- Investigational Product, TransCelerate Biopharma Inc., United States of America (the) Acquired Date: 2020-03
- Essential Documents, TransCelerate Biopharma Inc., United States of America (the) Acquired Date: 2020-02
- IRB Responsibilities and Informed Consent, TransCelerate Biopharma Inc., United States of America (the) Acquired Date: 2020-02
- Clinical Practice VS. Clinical Research, TransCelerate Biopharma Inc., United States of America (the) Acquired Date: 2020-01
- Certified CPR, American Red Cross, United States of America (the) Acquired Date: 2018-08
Languages/Fluency
English: Conversational - High, Reading - High, Writing - High, Medical Records/Terminology - High
Timeline
Clinical Trial Manager
ICON Plc
12.2025 - Current
Site Management Associate II
ICON Plc
02.2022 - 12.2025
Clinical Research Associate
ICON Plc, Formerly PRA Health Sciences
05.2021 - 01.2022
Clinical Trial Navigator Assistant
Javara
01.2021 - 05.2021
Full-Time Clinical Research Intern
Javara
08.2020 - 01.2021
High School, Diploma - undefined
Phillipsburg High School
Bachelor of Science - Clinical Research
University of North Carolina Wilmington
Drug Type Experience
- Drug Type: Biologic, Chemical Entity, Device, RNA Med, Vaccine (infectious disease)
- Therapeutic Area: Cardio-Metabolic Diseases, Infectious Disease, Hematology, Immunology, Neurology, Oncology, and Orthopedics/Orthopedic Surgery
- Subject Population: Adults and Geriatrics
System Experience
- EDC: Medidata RAVE and Veeva CDMS
- TMF: Veeva Vault, Phlex, Florence Healthcare
- IRT: Suvoda, Signant Health, and Endpoint
- Training portals: InvestigatorSpace, WCG and DrugDev
- IRB: Central Advarra, IRB
- Central Laboratory: PPD, LabCorp and Medpace
- ePRO questions: Clario and YPrime
- Imaging vendors: Clario
- Data risk based monitoring and signal system: CluePoints
- CTMS: Veeva CTMS, PSO, Veeva Vault CTMS
Protocol Therapeutic Experience
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Arrhythmia, Primary Indication: Atrial Arrhythmia, Role: Site/Study Coordinator, Number of Studies: 1, Duration: 3 mos, Phase: IV, Subject Population: GERIATRICS
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Cardiovascular Risk, Primary Indication: non-CV drugs, Role: Clinical Research Associate, Number of Studies: 1, Duration: 0 mos, Phase: III, Subject Population: Cardiovascular Subjects;ADULTS;GERIATRICS
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Heart Failure, Primary Indication: Cardiomyopathy, Role: Site Management Associate, Number of Studies: 1, Duration: 5 mos, Phase: III, Subject Population: ADULTS
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Heart Failure, Primary Indication: Cardiomyopathy, Role: Site Management Associate, Number of Studies: 1, Duration: 3 mos, Phase: III, Subject Population: Cardiovascular Subjects;ADULTS
- Therapeutic Area: Hematology, Indication Group: Lymphoma, Primary Indication: Epstein Barr Virus (EBV), Role: Site Management Associate, Number of Studies: 1, Duration: 5 mos, Phase: II, Subject Population: Oncology Subjects
- Therapeutic Area: Immunology, Indication Group: Autoimmune Disorders, Primary Indication: Sjögren's Syndrome, Role: Site Management Associate, Number of Studies: 1, Duration: 0 mos, Phase: II, Subject Population: African-American;Asian;Caucasian;Hispanic
- Therapeutic Area: Infectious Diseases, Indication Group: Vaccines, Primary Indication: Coronavirus Disease (COVID-19), Role: Other, Number of Studies: 1, Duration: 4 mos, Phase: III, Subject Population: ADULTS
- Therapeutic Area: Infectious Diseases, Indication Group: Vaccines, Primary Indication: Coronavirus Disease (COVID-19), Role: Site/Study Coordinator, Number of Studies: 1, Duration: 3 mos, Phase: III, Subject Population: ADULTS
- Therapeutic Area: Infectious Diseases, Indication Group: Vaccines, Primary Indication: Escherichia Coli (E-Coli), Role: Site Management Associate, Number of Studies: 1, Duration: 2 yrs, 7 mos, Phase: I/II, Subject Population: ADULTS
- Therapeutic Area: Neurology, Indication Group: Pain, Primary Indication: Migraine, Role: Site Management Associate, Number of Studies: 1, Duration: 5 mos, Phase: III, Subject Population: ADULTS
- Therapeutic Area: Oncology, Indication Group: Solid Tumors, Primary Indication: Bladder, Role: Site Management Associate, Number of Studies: 1, Duration: 11 mos, Phase: III, Subject Population: ADULTS
- Therapeutic Area: Oncology, Indication Group: Solid Tumors, Primary Indication: Breast, Role: Site Management Associate, Number of Studies: 1, Duration: 11 mos, Phase: III, Subject Population: Oncology Subjects
- Therapeutic Area: Oncology, Indication Group: Solid Tumors, Primary Indication: Head & Neck, Role: Site Management Associate, Number of Studies: 1, Duration: 1 mo, Phase: II, Subject Population: ADULTS
- Therapeutic Area: Orthopedics / Orthopedic Surgery, Indication Group: -, Primary Indication: Orthopedics, Non-Specified, Role: Site Management Associate, Number of Studies: 1, Duration: 6 mos, Phase: III, Subject Population: Adults
- Therapeutic Area: Orthopedics / Orthopedic Surgery, Indication Group: -, Primary Indication: Orthopedics, Non-Specified, Role: Clinical Trial Manager, Number of Studies: 1, Duration: 3 mos, Phase: III, Subject Population: Adults
- Therapeutic Area: Orthopedics / Orthopedic Surgery, Indication Group: -, Primary Indication: Orthopedics, Non-Specified, Role: Clinical Trial Manager, Number of Studies: 1, Duration: 3 mos, Phase: III, Subject Population: Adults
- Therapeutic Area: Orthopedics / Orthopedic Surgery, Indication Group: -, Primary Indication: Orthopedics, Non-Specified, Role: Site Management Associate, Number of Studies: 1, Duration: 5 mos, Phase: III, Subject Population: Adults
- Therapeutic Area: Vaccines, Indication Group: Vaccine, Coronavirus (COVID-19), Primary Indication: -, Role: Site Management Associate, Number of Studies: 1, Duration: 1 yr, 3 mos, Phase: II, Subject Population: Healthy volunteers;ADULTS
- Therapeutic Area: Vaccines, Indication Group: Vaccine, Coronavirus (COVID-19), Primary Indication: -, Role: Site Management Associate, Number of Studies: 1, Duration: 1 yr, 3 mos, Phase: IIB, Subject Population: Healthy volunteers