Shaun Crittenden
Valrico,FL
Summary
Clinical research professional with 19+ years of experience driving patient recruitment, managing regulatory submissions, and coordinating multi-phase studies. Achieved consistent enrollment gains through strategic outreach, protocol-driven eligibility review, and efficient scheduling. Strengthened study compliance by maintaining precise regulatory documentation. Committed to fostering collaborative environments that enhance team performance and contribute to impactful research outcomes
Overview
19
19
years of professional experience
Work History
Patient Recruitment Specialist /Regulatory Affairs Specialist
Stedman Clinical Trials
05.2020 - Current
- Lead patient recruitment efforts by prospecting, screening, and scheduling candidates using inclusion/exclusion criteria to ensure accurate eligibility assessment.
- Manage CTMS entries, patient accounts, daily visit tracking, and outreach logs to maintain full transparency across site operations.
- Conduct in-person and virtual prescreening via phone, text, social media, recruitment portals, and clinic databases, consistently boosting enrollment rates.
- Prepare and submit regulatory documents (INDs, amendments, annual reports) and maintain compliance with IRB, FDA, and GCP standards.
- Coordinate with sponsors, marketing teams, and recruitment vendors to optimize outreach campaigns and support business growth initiatives.
- Program and manage device settings for ~50 patients implanted with a Vagus Nerve Stimulator participating in a 5-year treatment-resistant depression study.
- Maintain accurate documentation, ensure timely reporting of adverse events, and serve as a liaison for research teams and regulatory authorities.
- Maintained an updated database of potential candidates for future opportunities, allowing for quick access to a qualified prospective patient pool for multiple indications.
Patient Recruitment Coordinator
Meridien Research Inc.
08.2019 - 03.2020
- Conducted high-volume prescreening (80–100 calls/day) and managed scheduling workflows in coordination with the clinic staff.
- Implementation of marketing/recruitment and community outreach initiatives such as participation in health fairs, community events, and support groups.
- Designated by management to train new team members on protocols and clinic structure.
- Provided regular reports to management on recruitment progress, highlighting successes and areas for improvement.
- Consistently met or exceeded enrollment goals for assigned trials.
- Collaborated with department supervisor and the marketing team to provide real time input on advertising and outreach campaigns to diversify ways to effectively reach potential trial candidates.
- Created trial specific scripts and patient questionnaires to efficiently determine eligibility criteria based on specific trial protocols.
Clinical Research Coordinator
Meridien Research Inc
09.2017 - 07.2019
- Managed approximately 70 study patients across various medical 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.
- Assisted Recruiting and Marketing Departments in reaching out to potential trial candidates to prescreen for trial 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.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Gathered, processed, and shipped lab specimens per protocol
Clinical Research Coordinator (Contract)
Innovative Research, Inc
06.2016 - 08.2017
- 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.
- Maintained regulatory documentation and files to ensure audit preparedness and compliance with institutional policies.
- Managed day-to-day clinical trial operations, ensuring adherence to study protocols and regulatory requirements.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Performed comprehensive data collection and verification to ensure accuracy and integrity of trial information.
Clinical Research Coordinator II
Moffitt Cancer Center
06.2015 - 05.2016
- Performed Primary Coordinator duties on multiple Immunotherapy and Oncology Clinical Trials
- Maintained comprehensive documentation of clinical trial activities, ensuring compliance with regulatory standards and institutional policies.
- 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.
- Participated in weekly inter-departmental clinical team meetings to discuss study progress, issues, and next steps, fostering collaboration and transparency.
- Established strong relationships with patients, guiding them through the research process and addressing their concerns with compassion.
Clinical Research Coordinator
University of South Florida
01.2007 - 06.2015
- Performed all primary Study Coordinator and Regulatory duties on over 20 clinical trial protocols including oncology and cancer treatment, pharmaceutical, medical device, and Investigator initiated studies within USF Health General Surgery Department.
- 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 violations, exhibiting Good Clinical Practice and thorough knowledge of the protocol.
- Provided in-service training to Surgeons, Residents, Fellows, Nursing Staff, Operating Room Staff, Anesthesia, and Laboratory Staff, to ensure full knowledge of various clinical trial 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.
Education
High School Diploma -
T.R. Robinson High School
Tampa, FLAssociate's Degree - Sciences
Florida Metropolitan University
Tampa, FLSkills
- Patient recruitment, prospecting & outreach
- Protocol review & eligibility determination
- Scheduling coordination & appointment management
- Cross-site communication & workflow support
- CTMS, EMR, EDC, IVRS, Microsoft Office
- Front office operations & professional communication
- Recruitment vendor collaboration & sponsor meetings
- Inventory management & marketing material coordination
- Regulatory compliance & GCP standards
- Multitasking, organization & attention to detail
- Clinical Trial Coordination
- Medical Device Programming
Timeline
Patient Recruitment Specialist /Regulatory Affairs Specialist
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
High School Diploma -
T.R. Robinson High School
Associate's Degree - Sciences
Florida Metropolitan University