Celeste Gonzalez Email & Phone Number

Round Rock, Tx, Us

Austin, Texas, United States

The Site Development Specialist (SDS) plays a key role in ensuring that Elligo PoweredBy® sites are qualified to conduct and execute the clinical studies effectively and efficiently. Is the primary point of contact for new Elligo Traditional sites. The SDS provides Study Management support to all sites or practices where trial support is needed. Provides site set up expertise to ensure new Elligo sites are in a position to qualify for and conduct clinical trials as quickly as possible after identification Evaluates site equipment needs and works with others at Elligo to ensure the appropriate research infrastructure is in place Assists with new investigator and site/practice staff training When applicable, serves as the study management point of contact for feasibility, PSVs, etc after practice handover and before a study manager/coordinator has been identified Assists with training and on-boarding (where appropriate) of new study staff (SM, SC) at sites/practices Assists with the interviews for new SC, SM staff Facilitates pre-study, site qualification, study initiation, monitoring visits and study close out activities for PoweredBy® sites Works with site personnel and Elligo project leads to monitor and assure Elligo/PoweredBy® services are delivered on time and with accuracy and completeness Manages documentation for all Elligo/PoweredBy® sites including training & development, SOPs Provides oversight of new SC, SM hires for up to 6 months to ensure they are competent in their role Works to cultivate productive relationships between site/practice and study personnel which will result in ongoing cooperation related to the coordination of research procedures, study visits and follow-up Maintains confidentiality, prioritizes and manages work effectively and provides exceptional customer service internally and externally Demonstrates knowledge of the Company’s clinical research studies

Austin, Texas

-Collaborates with the PI to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.- Attends investigator meetings- Collaborates with the PI to prepare IRB regulatory submission documents as required.- Prepares study materials as the ICF document, CRFs, enrollment logs, and drug accountability logs.- Establishes and organizes study files, and regulatory binders.-Reviews and develops a familiarity with the protocol, e.g., timelines, I&E criteria, confidentiality, privacy protections.- Assists PI in communication of study requirements. -Provides appropriate training and tools for study team members.-Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).-Conducts or participates in the informed consent process including discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.-Screens subjects for eligibility using protocol specific inclusion and exclusion criteria.-Coordinates participant tests and procedures.- Collects data as required by the protocol. Assures timely completion of Case Report Forms.- Maintains adequate inventory of study supplies. -Completes study documentation and maintains study files including, consent forms, source documentation, case report forms, and investigational material accountability forms.-Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.-Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable federal agencies, and the sponsor.-Makes sure all invoices are sent to the sponsor/CRO in timely manner and keep track of payment activity. -Make sure subjects are paid per executed CTA and track payments made.

Administratively and clinically manage an average of six to eight clinical trialsAdhere to Research SOP’sAdhere to Good Clinical Practices and the study protocolsEnsure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trialsDiscuss study protocols with patients and verify the informed consent documentationProvide patient with written communication of their participation (i.e. copy of the signed informed consent)Ensure patient’s referring physician receives notification of patient’s participation in studies as requested by the patientMeet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the studyDispense study medication in a professional and accountable manner following protocol requirementsCollect, process, and ship blood/urine specimens at scheduled patient visitsPerform ECGs and obtain vital signs of patientsSchedule all patient research visits and procedures consistent with protocol requirementsComplete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracyAdminister questionnaires/diaries per protocolEnsure that non-serious and serious adverse events are properly documented and reportedScreen all laboratory results when received and follow protocol procedure regarding abnormal resultsEnsure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binderSubmit patient reimbursement requests at the conclusion of patient’s participation in protocolEnsure the filing and maintenance of all regulatory documentsSchedule monitor visits and set up for monitoring visits prior to monitor’s arrivalOther duties as assigned.

Phase 1 UnitRecruitment and co-ordination of the trial subjects covering informed consent, screening and inclusion of the subjects adhering to safety and compliance issues, GCP.Co-ordination and management of the clinical trial, communication with sponsor and authorities, visit coordination, sampling, time management and product accountability. Data collection and management, collection of source documents, complete and develop source documentation, registration and management of AEs, filing and archiving, manage monitoring visits, answer queries. Work closely with doctors to follow patient progress.Draw, collect, process, and ship samples as needed, perform ECGs, PK overnight trials, Photography, KOH collection.Responsible for multiple protocols at one time.

Recruitment and co-ordination of the trial subjects covering informed consent, screening and inclusion of the subjects adhering to safety and compliance issuesCo-ordination and management of the clinical trial, communication with sponsor and authorities, visit coordination, sampling, time management and product accountabilityData collection and management, collection of source documents, using and developing CRFs, registration and management AEs, filing and archiving, managing monitoring visits, dealing with queriesClose-out of the clinical trial, contributing to research article, audit preparation, trial closure, communication with authorities and other disciplines involved, assisting in the final study report and completing financial obligations.Work closely with doctors to follow patient progressDraw, collect, process, and ship samples as needed, copy x-rays, perform ECGsResponsible for 13 different protocols at one timeResponsible for scheduling over 300 patients and maintaining follow up visits for a 7 year periodCustomer Service Representative for all patients needs before and after surgery

Responsible for screening and enrolling patients into select criteria studiesCreate and maintain databases for collecting and analyzing dataWork closely with doctors to follow patient progressUse programs such as Word, Access, and Excel on daily basisPrepare and process all documents and protocols for the Internal Review BoardManaged accounts payable for studies

Managed and set up operational procedures that increased efficiency and productivity Establish weekly work schedules for employees, monitor monthly sales goals Participate in interview process of all prospective employeesResponsible for maintaining daily store inventory suppliesValidate jewelers invoices against company price list for accuracyMonitor and Maintain a gross margin goal of 55% in repairsResponsible for presenting resolution information to store employeesDetermine proper storage of all business documents for the store Assume the duties of manager in their absence

Responsible for collecting and centrifuging samples, preparing samples for shipping, EKGs, initiating and downloading Ambulatory Blood Pressure Monitors- more than MA equivalent trainingCollecting and recording information for the Case Report Forms, keeping inventory of all study drugs, filing in regulatory binders, reporting to the IRB, and faxing enrollment logs dailyUsed web based programs to upload ABPM Worked closely with drug companies for initiation visits, monitor visits, and closeout visits

Handled customer service issues, Responsible for maintaining daily store inventory suppliesCreated report to provide daily Employee Sales Progress Monitor employees monthly sales goals Responsible for selling and meeting monthly goals

Education record

Education record