Helen Thomas

East Windsor, NJ

PROFESSIONAL SUMMARY:

Adaptive Clinical Research Coordinator skilled in multi-team management works with physicians and medical staffs. Demonstrating strong working Knowledge of ICH-GCP, regulatory guidelines, protocols and monitoring guidelines.

Accurate documenting reports while maintaining a high professional standard. Experience in multiple study areas including diabetes, Dermatology, Pain Management, Vaccine, Respiratory. Neurology, Rheumatology and women’s Health

EXPERIENCE:

Bristol Myers Squibb - Aug-2022- Present

Clinical Recruitment Specialist

●Builds and/or supports Recruitment Strategy Lead with building an indication level recruitment plan utilizing tactics that optimize the site/patient experience and trial recruitment timelines

●Implements selected tactics at the indication/protocol level

●Partners with Strategy Implementation Lead to ensure timely delivery of creative materials, digital/media plans, and other tactics in alignment with the overall plan

●Actively engages with indication/protocol level stakeholders regarding recruitment timelines, tactics, and site/patient insights

●Communicates status updates to team leadership

●Supports Recruitment Strategy Lead with vendor management, materials, monitoring recruitment, and updating Sponsor systems

CSSI, Jan- Aug 2022

Local Enrollment Specialist

●Identifies site client needs for patient recruitment activities

●Communicates client timelines and requests to appropriate departments

●Develops enrollment plans for the site to outline their patient recruitment activities

●Follows-up with clients to determine results of recruitment activities

●Motivates clients to focus on study patient recruitment goals

●Contacts patients based on client requests for follow-up

●Travels to sites to introduce services and/or coordinate recruitment efforts or assist in chart reviews

●Research and contacts appropriate physicians or community organizations on behalf of the site to assist with recruitment efforts

●When necessary, attends events on behalf of the site to assist in recruiting efforts

●Reports client trends to project management

Threewire, April 2019- Jan 2022

Clinical Research Coordinator

●Assist with ensuring compliance Standard Operating Procedures (SOP) & document applications.

●Adhere to Guideline for Good Clinical Practice (GCP).

●Assist with preparation for inspections, audits & monitoring visits. Maintain the security & confidentiality of participants' paper or electronic data (e.g., case report forms kept in a secure, locked space).

●Scheduling participants for study assessments/visits, required tests including visit-specific laboratory kits and/or paperwork preparation.

●Perform packaging & shipping of protocol specimens to the Sponsor lab in accordance with IATA/DOT regulations & Sponsor shipping guidelines.

●Coordinating the current consent documents and assist in the collection of protocol-required data w/ timely & accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions).

●Data entry of study activity onto a case report form (paper or electronic) and maintain a database program to track all study activity (i.e., study enrollment & consents)

●Assist in maintaining research charts & site regulatory files. Assist in ensuring that study-related, non-test article supplies are shipped & re-supplied according to protocol, including tracking expiration dates.

●AE reporting and report any potential protocol violations/deviations to the PI in a timely manner.

University Medical Pain Center, Somerset, New jersey Jan 2019 April 2019

Clinical Research Coordinator

●Screen, recruit, and coordinate all research subjects

●Performed vital signs, EKG, and collecting lab samples, store, and ship to central lab

●Budgeting of studies and reimbursements to subjects

●Data entry

●Report noncompliance through necessary channels

●Patients follow up.

New York Clinical Trials, Manhattan, New York Jan 2017 Jan 2019

Clinical Coordinator Assistant

●Established and organized study files, including but not limited to, regulatory binders, study specific source documentation and other materials.

●Ensured study protocols are implemented and maintained safe for all participants

●Screened, recruited, and coordinated all research subjects Coordinated participant tests and procedures.

●Collaborated well with team members to carry out daily assignments and achieve team targets.

Princeton Medical Institute, Princeton, New Jersey Feb 2017- Aug 2018

Clinical Research Intern

●Screening patients

●Observe TMS sessions and infusions and Perform ECGs and obtain vital signs of patients

●Coordinating and conducting community outreach events

●Administers and scores assessments such as functional disability ratings, side effects evaluations, neurocognitive measuring (MOCA/MMSE), and other clinical ratings.

●Ensure data completeness, maintaining research files, providing information to participants regarding research protocols and procedures

●Obtaining informed consent

●Conduct standardized research assessments with the participants different Neurological studies

●Administers and scores assessments such as functional disability ratings, side effects evaluations, neurocognitive measuring, and other clinical ratings.

Terrence Higgins Trust, Barking, London Oct 2008 – 2014

Health Liaison Officer

●Recruits, evaluates and educates patients regarding clinical trials

●Conducts Informed consent interview with study participant and caregiver

●Coordinates all aspects of study visit activities for the participant while ensuring protocol compliance

●Prepares local and central lab requisition forms. Ships biological specimens to central labs per protocol and regulatory requirements

●Updates and maintains regulatory binders. Prepares adverse event reports and protocol deviation reports for submission to IRB and to study the sponsor

●Assists the Principal Investigator in preparing the regulatory documents for IRB submissions, including review of consent forms, initial study review, and continuing review applications and protocol amendments

●Performs regular audits to ensure that the data that has been collected per clinical trial is complete and accurate to ensure that the protocol has been specifically followed

●Throughout clinical research ensures the safety and comfort of patients being evaluated. Supervises the scheduling of patients for clinical and biological laboratory evaluations and sets up educational workshops for participant so that they are informed of all procedures

EDUCATION:

Bachelor's Degree: Health Science, University of East London, London, 2011

Post-Graduation (International development): Brunel University, London, 2013

Associate Certificate: Clinical research Associate: Progressive Career Institute 2017

IATA Certifications -Mayo Clinic

GCP Certificate- CITI Transporting dangerous goods

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