Clinical Regulatory Supervisor

• May 2022 - Present

-Assists Study Team in protection of the rights and welfare of all human subjects research accordance with applicable regulations -Cooperates with GI Alliance Research compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office -Arranges secure storage of study documents that will be maintained according to Good Clinical Practice and federal regulations, or for the contracted length of time, whichever is longer -Oversees the onboarding, training, and development of regulatory staff, including Clinical Regulatory Assistants and Clinical Regulatory Coordinators -Provides guidance and support to regulatory staff for completion and follow-through of regulatory activities -Supervises daily activities of regulatory staff and regulatory items as they relate to clinical trials, including problem solving and effective communication -Assists with development and implementation of regulatory practices and procedures in accordance with GI Alliance Research policies, IRB requirements, and all applicable regulations -Knowledge of regulatory requirements for FDA, OHRP, other regulatory authorities and ICH guidelines for Good Clinical Practice -Ensures that all essential documents are completed, updated, and appropriately filed per applicable regulations and Sponsor requests for each GI Alliance Research clinical trial Show less

Clinical Research Coordinator

• Oct 2021 - Feb 2022

•Sustained comprehension of medical conditions to promote efficiency and more feasible relationships with both potential test subjects and our other departments. •Developed and implemented summary protocols which remained in adherence with NIH and GCP guidelines, for the clinical team to utilize for reliable efficiency when pre-screening and enrolling potential subjects. •Performed clinical research protocol duties by conducting and managing study procedures and complying with study specific requirements in accordance with NIH and GCP guidelines. •Assisted corporate with coordinating and executing new strategies to educate the community about the services we offered to promote growth. •Diligently answered incoming calls and completed daily outbound calls from various databases of potential candidates in efforts to pre-screen for study participation. •Worked closely with CRA’s to resolve any concerns regarding enrollment of patients. •Properly updated regulatory binders and inputted documents into an electronic system. •Managed closed-out studies inventories according to IATA procedures and guidelines. •Alternated as lead coordinator and main clinic liaison which built and coordinated relationships with study sponsors and UCCT to organize and manage clinical trials according to protocol requirements, Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal Regulations. Show less

Child Placing Specialist

• Sep 2020 - Oct 2021

-Completes accurately and updates timely all paperwork required to manage child’s care in the home. -Regularly reviews all documentation provided by foster parents and outside agencies and all other documentation relevant to assigned children and families upon receipt, makes immediate written request for missing or necessary documentation, and follows up until obtained. -Completes individual service plans for each child to ensure proper goals, care, areas of need, and progress. -Regularly oversees child’s progress and makes regular reports to supervisor. -Effectively coordinates provision of all therapeutic support services for children and collects all documentation relevant to those services. -Interviews all children privately regarding satisfaction with placement, foster family, and home situation. -Acts as a liaison with school personnel, children, and foster parents. -Reports suspected child abuse or neglect immediately. -Effectively communicates with DFPS regarding the child. -Maintains regular and effective communication with supervisor about all incidents and reports such immediately. -Effectively manages foster home and monitors family for compliance with all required regulations which included regular home inspections. -Communicated with referral agency to advocate for appropriate services for children. -Maintains regular and effective communication with the foster family, keeps them informed, and holds them accountable for child’s service plan requirements. -Makes regular visits to the foster home to observe family interactions/the home environment as well verification relative to the capacity of the family home. -Consistently works to develop the foster parents in the areas of teaching and training in the use of therapeutic behavior interventions, organizational skills, advocacy, professionalism, and completion of agency forms. -Acts as a liaison between child’s DFPS and foster family. Show less

Clinical Research Coordinator

• Jun 2018 - Nov 2019

•Attended local networking events to promote and market neurological and general medication clinical trials provided by our company. •Performed pre-screening and obtained necessary documentation to promote successful screening of test subjects in adherence to both inclusion and exclusion protocols and ICH guidelines. •Sustained comprehension of neurological conditions to promote efficiency and more feasible relationships with both potential test subjects and our other departments. •Presented information on new clinical trials to my department when assigned. •Assisted the business development team with coordinating and executing new strategies to educate the community about the services we offered. •Diligently answered incoming calls and completed daily outbound calls from various tracking devices and databases of potential candidates in efforts to pre-screen for study participation. •Worked closely with Study Coordinators and Outreach Manager to resolve concerns regarding enrollment of patients. •Assisted nurses with vitals as needed during a screening process. •Performed MMSE (i.e. memory assessment) on patients during a screening process and at networking events. Show less

• Oct 2013 - Jun 2018

•Assumed overall responsibility for assisting all case managers/ clients with finding and keeping housing of the client’s choice that is flexible, mobile, and conducive to their recovery. •Coordinated placement in transitional housing along with assisting clients with Housing Authority and H.U.D. applications which includes HMIS and VI-SPDAT. •Assisted clients in landlord/lease expectations, rights, and responsibilities. •Per requests of OCHCA Service Chief and FSP clinics, I developed and updated housing resources for employees and their clients to utilize. •Decided and mediated the process of potential tenants being placed into the PBV apartment called Diamond Aisle Apartments based on eligibility guidelines and supervised the on-site Residential Coordinator. •Coordinated and tracked housing expenses within the given budget from program. Show less

• Jul 2012 - Oct 2013

•Provided safe, effective, and efficient implementation of direct care with clients in accordance with established procedures, policies, and standards of care. •Established and maintained therapeutic relationships with clients while assisting with housing, finances, and mental health counseling. •Provided direct community support to persons being served. •Completed all records and documents accurately and within required time when services were provided. •Facilitated the acquisition of community resources and partnerships that allow clients employment opportunities off-site. •Attended and participated in all required community and FSP meetings to improve resources and client involvement. Show less

Counselor

• Apr 2009 - Dec 2011

•Assessed each resident and created weekly comprehensive treatment plans for my primary patients to help them reach their goals through set tools. •Facilitated behavioral, emotional, mental, physical, and spiritual growth through daily group interventions and daily individual interventions to help patients become more open to the recovery process. •Contributed to creating a well-structured and safe place for patients through set boundaries, provided support, and vigilance in milieu in order to build connections and trust with patients. •Exercised clinical judgment in times of peer conflict and patient crises to increase the rate of respect between patients and their abilities to resolve conflicts on their own. •Assisted with admission and discharge process to decrease the amount of transition time of integrating the patient into the milieu or preparing the patient for re-entry into the community. Show less

Respite Worker

• Jan 2006 - Dec 2008

•Instructed cognitive and behavioral skills, in a safe and structured environment, to an autistic boy. •Taught the autistic boy social skills by taking him into the community to practice what he had learned with me at his home. •Administered his daily prescriptions and food intake. •Assisted caseworkers with creating progress objectives that all trainers would integrate while on their shifts. •Taught parents the tools to apply with their autistic child when without professional assistance. Show less

Customer Service Representative

• May 2005 - Dec 2005

•Facilitated will-calls, reported backorder items, and reorganized the warehouse. •Answered multiple telephone lines and gave information to callers, took messages, or transferred calls to appropriate individuals. •Greeted visitors and handled their inquiries according to their needs. •Operated office equipment such as fax machines, copiers, and shredders, and used computers for spreadsheet, word processing, and database management. •Facilitated will-calls, reported backorder items, and reorganized the warehouse. •Answered multiple telephone lines and gave information to callers, took messages, or transferred calls to appropriate individuals. •Greeted visitors and handled their inquiries according to their needs. •Operated office equipment such as fax machines, copiers, and shredders, and used computers for spreadsheet, word processing, and database management.

University Registrar

• Aug 2004 - May 2005

•Answered multiple telephone lines and gave information to callers, took messages, or transferred calls to appropriate individuals. •Updated and filed student profiles, retrieved old and new transcripts, and set up an electronic filing system for records and correspondence. •Greeted visitors and handled their inquiries according to their needs. •Operated office equipment such as fax machines, copiers, and shredders, and used computers for spreadsheet, word processing, and database management. •Distributed incoming mail, completed forms in accordance with company procedures, and reviewed work done by others to check for correct spelling and grammar. Show less

Secretary Assistant

• Apr 2003 - Jul 2004

•Answered multiple telephone lines and gave information to callers, took messages, or transferred calls to appropriate individuals. •Greeted visitors and handled their inquiries according to their needs, set appointments, and filed and assembled tax returns. •Operated office equipment such as fax machines, copiers, and shredders, and used computers for spreadsheet, word processing, and database management. •Distributed incoming mail, completed forms in accordance with company procedures, and reviewed work done by others to check for correct spelling and grammar. Show less