Patient enrollment manager

Location:

Orlando, FL

Salary:

120000

Posted:

May 11, 2023

Contact this candidate

Resume:

Ma Theresa De Leon, RN, MD

***********@*****.*** 1337 Crane Crest Way Orlando Florida 32825 407-***-****

OBJECTIVE

To enhance medical research thru my experience with medical oncology clinical trials as a clinical research coordinator/preceptor for phase 2 to phase 4 clinical trials for 5 years and as a patient enrollment manager in phase 1 healthy and disease neurological trials for 2 years

WORK EXPERIENCE

Patient Enrollment Manager

PPD, now part of Thermo Fisher, Orlando, Florida

21Aug2021- Present

Managing phase 1 neurology healthy and disease clinical trials thru collaborating with CRU leadership and sponsor regarding patient enrollment by patient consenting, patient eligibility, and patient communication regarding patient status participation

Communicate with primary sponsor contact regarding patient status, patient enrollment, specific issues and study deliverables

Review and provide input on study enrollment and patient consenting with sponsor and CRU leadership thru managing and updating trial logs, patient consent and patient eligibility and patient status

Collaborates with CRU leadership regarding CRU patient status, enrollment and eligibility following study protocol with sponsor guidance

Mange risk assessment with patient enrollment status and eligibility by collaborating with Medical Director, Medical investigator and Director

Responsible for managing patient enrollment and patient status

Collaborating with CRU leadership regarding SOP implementation regarding CRU rules, regulations and management

Managing and collaborating with CRU leadership regarding SIV and sponsor access thru ERT and IRT in regards to patient enrollment and consenting

Responsible for managing proper consenting process and patient screening onsite with team

Collaborating and managing with sponsor and company CRA thru ePIP, ERT and IRT.

Collaborating with CRU leadership team, clinical research managers, medical director and investigators regarding patient enrollment status by managing team regarding laboratory results, patient communication, clinical trial logs and check in process

Managing with team regarding patient consenting process and screening patients in phase 1 neurology healthy and disease clinical trials

Managing with team and CRU leadership team regarding patient screening process using patient EMR and enrollment thru ERT, IRT and laboratory companies.

Assist in the development and maintenance of new processes and procedure to ensure efficient clinical research operations

Collaboration with clinical research managers and CRU leadership regarding patient enrollment and follow up status

Attending/managing SIV clinical trials

Responsible for managing team regarding HIPPAA rules and regulation regarding patient consenting, screening and enrollment

Lead Clinical research coordinator/ Preceptor- Gastrointestinal Cancer Disease Research

Co-Lead in Clinical research coordinator/Preceptor - Head, Neck, Thoracic and Lung Cancer Disease Research

Orlando Health Cancer Institute, Orlando, Florida

16Jul2018 – 13Aug2021

Responsible for managing sponsored and Investigator Initiated Trials in accordance with FDA and ICH/GCP regulations and guidelines

Responsible for confirmation of eligibility and enrollment of patients upon referral

Responsible for screening subject using patient EMR and enrolling subjects based on I&E criteria per research study protocol

Responsible for the overall ongoing progress of clinical research trials from pre-screens through study completion

Assist in the development and maintenance of new processes and procedure to ensure efficient clinical research operations

Coordinate studies for Gastrointestinal and Head & Neck, Thoracic clinical trial

Coordinate Gastrointestinal and Head & Neck, Thoracic Cancer clinical trials

Coordinate cancer registries

Coordinate Device trials

Responsible for clinical trial data collection upon subject enrollment, active surgical procedures, and study subject follow-up visits

Responsible for checking subject EMR during unscheduled visits and AE updates

Responsible for reviewing all elements of the current institutional IRB approved informed consent (IC) document, according to current FDA, NCI, and state, federal and institutional regulations with study candidates and/or legal representative

Assist new onboarded research coordinators, research fellows and research v volunteers with protocol and research training

Provides administrative support to the department by providing research meeting coordination, taking meeting minutes, and coordinating necessary travel arrangements with a high level of accuracy and good judgment.

Work closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment

Coordinate and attend sponsor prequalification visits, monitor visits, study termination visits.

Making outbound calls to assess and follow up patient status

Respond to data clarification requests in a timely manner

Responsible for database construction with input from department director or immediate supervisor

Provides administrative support to the department by assisting with policy and procedure development and annual updates, upkeep of regulatory binders, and filing.

Provides administrative support to the department by conducting data entry into established databases with a high level of accuracy.

Identify gaps and or barriers in treatment plans

Demonstrates through human subject advocacy and informed consent as an ongoing process, that the rights, safety, and well-being of trial subjects are the most important considerations and should prevail over the interests of science and society

Responsible for special projects as assigned by department director and immediate supervisor

Interact with medical directors on challenging cases

Responsible for the immediate oversight of the study conduct during the pre-study, active and follow up phase, for all assigned studies.

Responsible for accurate and timely submission of data forms for assigned studies

Responsible for communication across a wide variety of internal hospital departments and the principal investigators (PI) of assigned studies.

Promotes PI oversight by advising the PI, sub-investigator, and department director or immediate supervisor of deviations in conduct, subject or study status, issues relevant to the integrity of the trial and/or the safety of research subjects

Maintain study database that records details of clinical trial shipments, and in collaboration with the CRA ensure that there are adequate supplies of clinical trial material to meet project needs

Schedule patients for study visits using Microsoft Outlook Calendar

Utilize CERNER System to update patients’ medical records and for patient registration

Assist in the development and implementation of recruitment strategies to increase patient randomization into the trial

Maintain a study database that records details of clinical trial shipments, and in collaboration with the CRA ensure that there are adequate supplies of clinical trial material to meet project needs.

Enters and updates patients’ Personal Health information (PHI) into database for recruiting

Assists with the analysis of research data using macros that enable machine to database communications

Use of IRB/NIH sites to obtain new research study protocols and inform consents (ICF)

Screen all patients based on study protocol I&E criteria

Data Management for responsible clinical trials

Coordinate with Research subject recruiting via phone or email

Coordinate with Patient Information Filing and coordination based on HIPAA regulations

Lead Clinical Research Coordinator/Preceptor- Gastrointestinal Cancer Disease Research

Lead Clinical Research Coordinator/Preceptor - Brain Cancer Disease Research

Co- Lead Clinical Research Coordinator- Genito-urinary/Renal Cancer Disease Research

Florida Hospital Cancer Institute, Orlando, Florida

04Aug2015-06Jul2018

Schedule patients for study visits using Microsoft Outlook Calendar

Utilize CERNER System to update patients’ medical records and for patient registration

Assist in the development and implementation of recruitment strategies to increase patient randomization into the trial

Maintain study database that records details of clinical trial shipments, and in collaboration with the CRA ensure that there are adequate supplies of clinical trial material to meet project needs.

Enters and updates patients’ Personal Health information (PHI) into database for recruiting

Assists with the analysis of research data using macros that enable machine to database communications

Use of IRB/NIH sites to obtain new research study protocols and inform consents (ICF)

Screen all patients based on study protocol I&E criteria

Data Management for responsible clinical trials

Proper documentation of patient visits and adverse events in regards to clinical drugs

Educate patients on cancer disease process and clinical trial drugs

Coordinate with Research subject recruiting via phone or email

Coordinate with Patient Information Filing and coordination based on HIPAA regulations

Responsible for managing sponsored and Investigator Initiated Trials in accordance with FDA and ICH/GCP regulations and guidelines

Responsible for confirmation of eligibility and enrollment of patients upon referral

Follow up and making calls for patient needs and updates and coordinating to all members of healthcare team so the patient can have resources and necessary services

Utilizing management skills to provide appropriate care and request appropriate health care services to patients, procedures and cancer treatment in relation to clinical trials

Responsible for screening subject using patient EMR and enrolling subjects based on I&E criteria per research study protocol

Responsible for the overall ongoing progress of clinical research trials from pre-screens through study completion

Responsible for enrolling subjects and coordinate research trials for hernia patients scheduled for surgery

Assist in the development and maintenance of new processes and procedure to ensure efficient clinical research operations

Coordinate studies for Gastrointestinal and Head & Neck, Thoracic clinical trial

Coordinate Gastrointestinal and Head & Neck, Thoracic Cancer clinical trials

Coordinate cancer registries

Coordinate Device trials

Responsible for clinical trial data collection upon subject enrollment, active surgical procedures, and study subject follow-up visits

Responsible for checking subject EMR during unscheduled visits and AE updates

Assist new onboarded research coordinators, research fellows and research v volunteers with protocol and research training

Work closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment

Coordinate and attend sponsor prequalification visits, monitor visits, study termination visits.

Providing patient education on chemotherapy and oncology

Respond to data clarification requests in a timely manner

Coordinating care for patients and chemotherapy

Educate patients regarding healthy lifestyle and chemotherapy in regards with clinical trial