Deanna Shaffer
Santee,CA
Summary
Experienced research professional seeking a growth opportunity while remaining in the Clinical Research field. Dependable, hardworking, and diligent worker. Excellent problem solving and interpersonal skills. Proven adaptability and ability to flourish in a high paced, environment.
Overview
21
21
years of professional experience
Work History
Clinic Manager/ Clinical Research Coordinator
California Neuropsychopharmacology Clinical Research Institute
12.2022 - Current
- Clinical Research Coordinator for Phase I-IV CNS clinical drug trials for Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depression, Hypertension, Diabetes, Fibromyalgia
- Assist the PI in the conduct of the clinical study according to FDA and sponsor regulations and guidelines while ensuring the safety and welfare of research participants
- In-depth knowledge of departmental, protocol and study specific operating procedures, consent forms and study schedules
- Supervise the work of 15 employees in supporting roles, including assigning workload and ensure proper workflow
- Onboarding, mentoring, and training new and junior clinical research personnel including research assistants, medical assistants, and laboratory technicians
- Recruit screen, enroll and follow study subjects ensuring protocol compliance and close monitoring to ensure eligibility of subjects prior to consenting
- Responsible for all data collection, source documentation, developing and collection and reporting adverse events and serious adverse events
- Maintain several lab and ECG portals including LabCorp/ Covance, Q2-Quintiles, PPD Labs, Lab Connect, Quest, ERT, Cardio portal, Signant Health
- Dispense and maintain Investigational study medication records per protocol requirement
- Resolved patient complaints in a timely manner, ensuring a positive experience for all parties involved.
- Hired, trained and supervised employees to maintain team of high performers.
- Conducted regular staff evaluations, providing constructive feedback and setting clear expectations for future performance goals.
- Created and implemented policies to improve operational efficiency and patient care quality.
Inpatient Research Nurse/ Charge Nurse
San Diego Behavioral Health
09.2022 - Current
- Supervise the work of 15 employees including assigning workload scheduling of staff and ensure proper workflow
- Manages unit staff on a 14-bed inpatient unit
- Perform nursing duties on site inpatient unit
- Follows all sponsor protocols for inpatient studies
- Collects, manages, and maintains patient vital signs, and lab and ECG data
- Monitors for Adverse Events, patient compliance with protocol procedures and IP administration
Clinical Research Coordinator-CRC (2014-2016), Quality Control Specialist/ CRC (2014-2020), Operations Manager/ CRC (2020-2022)
Pacific Research Network
01.2014 - 12.2022
- Clinical Research Coordinator for Phase I-IV CNS clinical drug trials for Alzheimer’s Disease, Dementia, Memory Loss, Sleep Apnea, Insomnia, COPD, and Hypertension
- Assist the PI in the conduct of the clinical study according to FDA and sponsor regulations and guidelines while ensuring the safety and welfare of research participants
- In-depth knowledge of departmental, protocol and study specific operating procedures, consent forms and study schedules
- Supervise the work of 15 employees in supporting roles, including assigning workload and ensure proper workflow
- Onboarding, mentoring, and training new and junior clinical research personnel including research assistants, medical assistants, and laboratory technicians
- Recruit screen, enroll and follow study subjects ensuring protocol compliance and close monitoring to ensure eligibility of subjects prior to consenting
- Responsible for all data collection, source documentation, developing and collection and reporting adverse events and serious adverse events
- Maintain several lab and ECG portals including LabCorp, Covance, Q2-Quintiles, PPD Labs, Lab Connect, Quest, ERT, Cardio portal, Signant Health, Mayo Lab, ECCO Lab, ACM Lab, Neuromedix, Cenetron, and Suvoda
- Dispense and maintain Investigational study medication records per protocol requirement
Clinical Research Coordinator/ Inpatient Research Nurse
California Neuropsychopharmacology Clinical Research Institute
01.2004 - 01.2014
- Clinical Research Coordinator for Phase I-IV CNS clinical drug trials for Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depression, Hypertension, Diabetes, Fibromyalgia
- Assist the PI in the conduct of the clinical study according to FDA and sponsor regulations and guidelines while ensuring the safety and welfare of research participants
- In-depth knowledge of departmental, protocol and study specific operating procedures, consent forms and study schedules
- Supervise the work of 15 employees in supporting roles, including assigning workload and ensure proper workflow
- Onboarding, mentoring, and training new and junior clinical research personnel including research assistants, medical assistants, and laboratory technicians
- Recruit screen, enroll and follow study subjects ensuring protocol compliance and close monitoring to ensure eligibility of subjects prior to consenting
- Responsible for all data collection, source documentation, developing and collection and reporting adverse events and serious adverse events
- Maintain several lab and ECG portals including LabCorp/ Covance, Q2-Quintiles, PPD Labs, Lab Connect, Quest, ERT, Cardio portal, Signant Health
- Dispense and maintain Investigational study medication records per protocol requirement
- Manages unit staff on a 16-bed inpatient unit
- Perform nursing duties on site inpatient unit
- Collects, manages, and maintains patient and laboratory data and ECG data for clinical research studies
- Monitors for Adverse Events, patient compliance with protocol procedures and IP administration
- Performs vital signs, Lab draws, ECG’s, etc
- Per study protocol procedures
Education
IATA CERTIFICATION -
PHLEBOTOMY AND BLOOD WITHDRAWAL CERTIFICATION -
01.2015
LICENSED VOCATIONAL NURSE, LVN-CA -
01.2004
IV THERAPY TRAINING-CA -
01.2002
PHLEBOTOMY CERTIFICATION-NY -
01.1998
LICENSED PRACTICAL NURSE, LPN – NY -
01.1996
CERTIFIED NURSING ASSISTANT, CNA-NY -
01.1994
Skills
- Administrative Leadership
- Clinical management
- Staff Management
- HIPAA Compliance
- Employee Training
- Good Clinical Practice
- Federal Regulations
- Rating scales
- GCP guidelines
- Phlebotomy
- IV therapy
- Lab processing guidelines
- Site-specific SOP’s
- HIPAA Compliance
- Employee Recruitment
- Scheduling appointments
- Patient Care Coordination
- Program Management
- Records Management
- Supply Coordination
- Training and mentoring
- Employee Work Scheduling
- Basic Life Support for Health Care Providers
- Heartsaver First Aid CPR AED (First Aid CPR AED)
- Patient education and counseling
- SIP-Shared Investigator Platform
- CTMS systems
- AiCure
- Fire Crest
Experience in the following sites:
- Exostar
- Veeva Vault
- Drug Dev
- Blue Cloud
- Study Works
- Trial Master
- Quest
- Medidata
- Oracle
- Med pace
- IQVIA
- ECaselink
- Inform
- EPIP
- IRT
- 4G clinical
- Signant
- Bracket
- RTSM-Bracket
- Secure Endpoint
- Clinphone
- Cenduit
- Almac
- PPDi
- Yprime
- Cogstate
- Neurocog
- Verasci
- Pathway
- Medavante
Timeline
Clinic Manager/ Clinical Research Coordinator - California Neuropsychopharmacology Clinical Research Institute
12.2022 - Current
Inpatient Research Nurse/ Charge Nurse - San Diego Behavioral Health
09.2022 - Current
Clinical Research Coordinator-CRC (2014-2016), Quality Control Specialist/ CRC (2014-2020), Operations Manager/ CRC (2020-2022) - Pacific Research Network
01.2014 - 12.2022
Clinical Research Coordinator/ Inpatient Research Nurse - California Neuropsychopharmacology Clinical Research Institute
01.2004 - 01.2014
Family Health Center San Diego - PHLEBOTOMY AND BLOOD WITHDRAWAL CERTIFICATION,
- LICENSED VOCATIONAL NURSE, LVN-CA,
San Jacinto Community College - IV THERAPY TRAINING-CA,
Erie2-BOCES-Phlebotomy training - PHLEBOTOMY CERTIFICATION-NY,
Erie2-BOCES-Licensed Practical Nurse Program - LICENSED PRACTICAL NURSE, LPN – NY,
Jamestown Community College - CERTIFIED NURSING ASSISTANT, CNA-NY,
CNRI - IATA CERTIFICATION,
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