Jennifer Austin

Managed coordination of clinical trials in compliance with FDA and GCP standards.
Proactively identified issues and implemented appropriate solutions during trials.
Articulated protocol challenges to CROs, Sponsors, and study team members as needed.
Gathered initial subject health information by conducting interviews and reviewing records.
Evaluated subject eligibility based on comprehensive medical documentation under guidance of Principal Investigator.
Ensured effective communication channels between all stakeholders involved in the study.
Conducted essential clinical tasks such as vital signs monitoring and specimen management.
Maintained accurate records for investigational products and resolved queries promptly.

• Ensured accurate input of trial data into EDC system by verifying and correcting source documents.
  Monitored visits and procedures in CTMS, maintaining compliance with budget limitations.
  Supported maintenance of regulatory and ethics documentation, coordinated subject visits, and produced essential reports.
  Provided organizational support by managing office supplies and maintaining efficient workspace.

• Ensured strict adherence to GCP’s SOPs and clinical trial protocols for diverse studies.
  Oversaw coordination of Phase II-IV clinical trials focusing on operational excellence.
  Executed recruitment efforts while performing eligibility screenings for subjects.
  Managed patient visit schedules and confirmed attendance effectively.
  Conducted patient care visits according to study protocols without deviation.
  Handled reception and dispensing of study medications, maintaining detailed accountability logs.
  Engaged in data collection, database management, and preliminary analysis tasks.
  Coordinated monitoring visits, addressing data queries thoroughly.

• Prepared new protocol submissions, site applications, amendments, and renewals for IRB compliance.
  Maintained regulatory binders, case report forms, subject charts, and source documents.
  Conducted quality assurance checks to ensure data integrity and compliance.
  Created and managed source documents while archiving and maintaining detailed records.
  Ensured adherence to GCPs, SOPs, and study protocols for multiple clinical trials.
  Coordinated Phase II-IV clinical trials to meet project timelines and objectives.
  Performed phlebotomy, IV preparation, 12-lead EKGs, and clinical testing per protocol requirements.

• Conducted health screenings for patients entering Miami Dade County Corrections Department.
  Collected vital signs, height, weight, and performed 12 Lead EKGs.
  Executed phlebotomy and injections, centrifuged serum tubes, and conducted laboratory tests.
  Assisted in managing medical emergencies to ensure patient safety.
  Registered patients in Cerner and Miracle systems for comprehensive data tracking.

• Conducted behavioral health study visits according to established protocols for various research sites.
  Created and managed source documents, ensuring proper archiving and maintenance of detailed records.
  Ensured compliance with GCP standards, SOPs, and study protocols across multiple clinical trials.
  Coordinated Phase II-IV clinical trials, facilitating smooth project execution.
  Assisted in study development by reviewing protocols and designing case report forms.
  Prepared informed consent forms and developed related study documents.
  Performed phlebotomy, including venipuncture, intravenous catheter insertion, and IV preparation.
  Administered 12 lead EKGs to monitor patient health during studies.

• Conducted frequent phlebotomy, including venipuncture and intravenous catheter injections.
  Measured vital signs, height, weight, elbow breadth, and frame size.
  Performed 12 Lead EKGs and monitored cardiac Holter readings.
  Executed laboratory testing by adding additives and chemicals to process solutions.
  Utilized Eppendorf manual pipette and various glass and plastic pipettes for sample preparation.
  Coordinated sample shipments and packaging while tracking through FedEx and UPS.
  Maintained cleanliness and sterilization of all laboratory equipment.

• Selected volunteers for clinical trials while conducting procedures during study phases.
  Regularly executed phlebotomy tasks such as venipuncture and intravenous catheter injections.
  Measured vital signs, height, weight, elbow breadth, and frame size to assess participants.
  Administered 12 Lead EKGs and utilized cardiac Holter monitors for diagnostic evaluations.
  Performed laboratory testing by adding specific additives or chemicals to product batches.
  Operated Eppendorf manual pipette and repeating pipette for accurate sample manipulation.
  Oversaw shipment logistics by packaging samples and coordinating with FedEx and UPS tracking.
  Ensured sterilization of laboratory equipment through meticulous cleaning protocols.

• Executed procedures during clinical studies after selecting qualified volunteers.
  Collected blood samples, recorded vital signs, and assessed height, weight, and frame size.
  Administered 12 Lead EKGs to monitor participant health conditions.
  Conducted urine and saliva screenings to detect restricted substances.
  Facilitated subject admissions for in-house trials per established protocols.
  Delivered essential administrative support for efficient trial management.