SHAUN CRITTENDEN
Valrico,FL
Summary
Dynamic professional with over 19 years of experience in the clinical research industry, specializing in patient interaction and recruitment strategies. Proven ability to achieve enrollment goals through a proactive approach and effective communication. Highly skilled in managing multiple priorities while maintaining a positive attitude. Committed to fostering collaborative environments that enhance team performance and contribute to impactful research outcomes.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Patient Recruitment Specialist/Regulatory Affairs
Stedman Clinical Trials
Tampa, Florida
05.2020 - Current
- Patient Recruitment - Prescreen clinical trial candidates in person, via telephone, text, social media, sponsor provided recruitment portals, or clinic database, to review eligibility for placement into ongoing clinical trials.
- Schedule qualifying candidates for screening visits when trial specific inclusion/exclusion criteria is met.
- Implementation of marketing/recruitment and community outreach initiatives such as participation in health fairs, community events, and support groups.
- Creating and managing social media (Facebook) ad campaigns as necessary to boost enrollment in ongoing clinical trials and contacting generated leads.
- Regulatory Specialist - Prepare and submit regulatory documents like Investigational New Drug (IND) applications, protocol amendments, and annual reports.
- Manage the submission and approval process with Institutional Review Boards (IRBs) and regulatory agencies like the FDA, ensuring adherence to standards such as Good Clinical Practice (GCP)
- Serve as the primary contact for research teams, sponsors, and regulatory authorities, coordinating interactions and responding to inquiries.
- Monitor study conduct to ensure patient safety and data integrity, and report adverse events and protocol deviations.
- Maintain all study documentation, records, and databases in an organized and compliant manner.
- VNS Therapy for Depression Device Programmer - Over the last 5 years, have maintained roughly 50 patients implanted with a Vagus Nerve Stimulator, who are enrolled in a 5 year Treatment Resistant Depression Trial.
- Initial programming often starts at a low level and is gradually increased over weeks or months to find the right therapeutic dose for the patient.
- Monitors the patient's response and side effects to make further adjustments at follow-up appointments.
- Transferring all patient programming changes and settings into Electronic Data Capture system, satisfying queries, and periodic uploading of this information from programmer tablet into the EDC.
- Unblinded Pharmacist -Receiving, securely storing (including temperature monitoring), managing inventory, and ensuring proper disposition (return to sponsor or destruction) of all IMPs.
- Preparing and labeling the study medication (active drug or placebo) according to the study protocol and randomization schedule
- Maintain meticulous, unblinded records for drug accountability, including master and subject-specific logs.
- Working closely with the research team to ensure compliance with the study-specific blinding plan and all applicable regulations.
Patient Recruitment Coordinator
Meridien Research Inc.
Lakeland, FL
08.2019 - 03.2020
- Prescreen clinical trial candidates by telephone, text, and email to review their medical history for placement into ongoing trials or add to database for future trials.
- Scheduling qualifying candidates for screening visits when trial specific inclusion/exclusion criteria is met.
- Implementation of marketing/recruitment and community outreach initiatives such as participation in health fairs, community events, and support groups.
- Monitored social media and online sources for recruitment trends to improve no show rates in clinics and diversify ways to reach potential trial candidates.
- Consistently met or exceeded enrollment goals for assigned trials.
- Designated by management to train new team members on protocols and clinic structure.
- Completed and managed 80-100 calls per day.
Clinical Research Coordinator
Meridien Research Inc
Lakeland, Florida
09.2017 - 07.2019
- Managed approximately 70 study patients across various indications
- .Coordinated clinical trials focused on disorders such as Major Depression, Anxiety, Adult and Pediatric ADHD, Low Testosterone, Gout, and Substance Abuse.
- Maintained all Good Clinical Practice and Human Subjects Training Certifications as well as other industry required certifications.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Assisted Recruiting Department in reaching out to potential trial candidates to prescreen for participation.
- Developed new methods to screen patient records, databases, and referrals to identify prospective candidates for research studies and increase number of potential candidates seen in clinic.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Gathered, processed, and shipped lab specimens.
- Drove operational improvements which resulted in savings and improved profit margins.
Clinical Research Coordinator (Contract)
Innovative Research, Inc
Tampa, FL
06.2016 - 08.2017
- Maintain sound conduct of clinical trials, including but not limited to recruitment, screening, education, enrollment, treatment and follow-up of eligible subjects according to protocol requirements and reporting of adverse drug experiences to the FDA.
- Completed study start up procedures which included Institutional Review Board required documents and forms.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Managed patient recruitment and retention efforts, enhancing study participation rates.
Clinical Research Coordinator II
Moffitt Cancer Center
Tampa, FL
06.2015 - 05.2016
- Performed Primary Coordinator duties on Immunotherapy and Oncology Clinical Trials that are changing how various cancers and other diseases are treated to obtain best outcomes for affected cancer patients.
- Maintain sound conduct of clinical trials, including but not limited to recruitment, screening, education, enrollment, treatment and follow-up of eligible subjects according to protocol requirements and reporting of adverse drug experiences to the FDA.
- Appointed by management to perform approximately 10 month long internal audit of 44 patients to identify quality deficiencies and misreported data.
- Creation of Corrective Action Plan based on audit findings alongside management and faculty to satisfy Institutional Review Board and FDA requests.
- Executed compliance with protocols covering patient care and clinical trial operations.
Clinical Research Coordinator
University of South Florida
Tampa, FL
01.2007 - 06.2015
- Performed all primary Study Coordinator duties on over 20 clinical trial protocols including oncology and cancer treatment, drug, medical device, and Investigator initiated studies within USF Health General Surgery Department. For 25% of these trials, top enrollment honors were achieved and recognized by industry sponsors as well as University of South Florida and Tampa General Hospital.
- FDA Establishment Inspection was performed on one trial in which I was primary coordinator. This FDA audit yielded no "483" form, concluding that trial was performed without any violation, exhibiting Good Clinical Practice and thorough knowledge during execution of the protocol.
- Provided in-service training to Surgeons, Residents, Fellows, Nursing Staff, and Laboratory Staff, to ensure full knowledge of study protocols.
- Accurately and ethically maintained trial specific patient records for sponsor audits and database verification.
- Oversaw and educated medical students and interns regarding clinical research practices to assist with protocol development and proper communication with Institutional Review Boards, Feasibility Boards, and Scientific Review Boards.
- Role was essential in introduction and availability of new studies to patient population resulting in increased revenue for USF Health Department of Surgery.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Oversaw site visits and audits, addressing findings to maintain high-quality standards in research practices.
- Gathered, processed, and shipped lab specimens.
- Prepared and maintained regulatory documents for clinical trial submissions.
Education
Associate's Degree - Sciences
Florida Metropolitan University
Tampa, FLHigh School Diploma -
T.R. Robinson High School
Tampa, FL1995
Skills
- Exceptional Interpersonal Communication
- Attentiveness & Positive Attitude
- Creative Problem Solving
- Organization and Time Management Skills
- Electronic Data Capture System proficiency
- Understanding of Clinical Trial Protocols
- Clinical documentation management
- Clinical assessments
- Oncology and Immunotherapy research experience
- Psychiatry research experience
- General Medicine research experience
- Medical Device research experience
- Patient Recruitment
- Social Media Recruitment and Marketing
- Regulatory Compliance and Oversight Reporting
- Unblinded Pharmacist Duties
- Vagus Nerve Implant Programming and Maintenance
- Recruitment Portal proficiency
- CTMS, IVRS, EMR proficiency
Certification
Good Clinical Practice Certification
Human Subjects Research Certification
Basic Lifesaving Measures Training and Certification
CPR Certification
Continuing Education as required per Clinical Trial Sponsor / Entity
Continuing Education as required per Institutional Review Boards
Timeline
Patient Recruitment Specialist/Regulatory Affairs
Stedman Clinical Trials
05.2020 - Current
Patient Recruitment Coordinator
Meridien Research Inc.
08.2019 - 03.2020
Clinical Research Coordinator
Meridien Research Inc
09.2017 - 07.2019
Clinical Research Coordinator (Contract)
Innovative Research, Inc
06.2016 - 08.2017
Clinical Research Coordinator II
Moffitt Cancer Center
06.2015 - 05.2016
Clinical Research Coordinator
University of South Florida
01.2007 - 06.2015
Associate's Degree - Sciences
Florida Metropolitan University
High School Diploma -
T.R. Robinson High School