Job Search Status
Open to workDesired start date: 2 weeks notice
Work Type
Full TimeLocation Preference
RemoteHybridOn-SiteOpen to relocation: Yes
Open To Work
Joseph Swanson
Saint Johns,FL
Work Preference
Summary
Dynamic Senior Clinical Research Associate with extensive experience, excelling in regulatory compliance and site management. Proven track record in enhancing data collection efficiency and mentoring teams. Strong communication and protocol understanding skills drive successful project outcomes, ensuring client satisfaction and adherence to Good Clinical Practice standards.
Overview
33
33
years of professional experience
Work History
Senior Clinical Research Associate
Parexel
Durham, NC
04.2023 - Current
- Led site management activities to ensure compliance with regulatory requirements and study protocols.
- Mentored junior associates, enhancing team performance and knowledge in clinical trial processes.
- Developed and implemented strategies for improving data collection efficiency across multiple studies.
- Coordinated cross-functional teams to streamline communication and project timelines for clinical trials.
- Served as primary liaison between clients and sites, ensuring alignment on study objectives and deliverables.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Communicated project status to [Type] management verbally and through technical documentation and presentations.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Senior Clinical Research Associate
Syneos Health
04.2022 - 03.2023
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Aided the the site subject recruitment, and retention programs through the utilization of social media, and different subject gifts and reimbursement options.
- Lead CRA for Sickle Cell Clinical Trial.
- Mentored junior CRA's through remote calls, observation visits, and holding weekly training.
- Reviewed Monitoring Reports, and submitted to Sponsor for review and TMF filing.
Clinical Research Associate II
PPD Development
02.2022 - 04.2022
- Clinical Research Associate II (CRA II) on 3 global studies, as a CRA II performs site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Supports development of project subject recruitment plans on a per site basis. Works with sites to adapt, drive, and track subject recruitment and retention plans in line with project needs to enhance predictability.
- Provides monitoring visit and site management for a variety of protocols, sites, and therapeutic areas.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Manages the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Senior Country Approval Specialist
PPD Development
02.2021 - 03.2022
- As Senor Country Approval Specialist, coordinated local and central IRB/EC regulatory submissions.
- Provided regulatory advice to clients for IRB/EC submissions and strategy.
- Provides technical expertise and coordination oversite for projects in collaboration with relevant internal departments.
- Serves as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
- Ensured that all subject recruitment information, and retention documents were submitted to IRB.
- Ensures guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
- Acts as a key-contact at country level for all submission-related activities.
- Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
- Achieves PPD's target cycle times for site activations.
- Prepares the regulatory compliance review packages, as applicable.
- Develops country specific patient information sheet/informed consent form documents.
- Assist with budgets(s) and payment schedules negotiations with sites. Supports the coordination of feasibility activities, as required, in accordance with timelines.
- Ensures that trial status information relating to SIA activities are accurately maintained in the database and is always current. Directs/mentors other SIA individuals assigned to support projects of responsibility, as appropriate.
Clinical Research Associate
IQVIA
03.2019 - 02.2021
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
Maintained site monitoring schedules to facilitate effective communication with members of clinical team. - Submitted routine Monitoring Visit reports and follow-up letters to facilitate internal and external communication.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Research Protocol Specialist
Mayo Clinic
07.2015 - 02.2019
- As Lead Research Protocol Specialist (RPS) oversaw the training and development of 15 RPS's in a 3-year timeframe.
- Provided consultative guidance regarding regulatory recruitment, and retention requirements to physicians, study staff, and external sponsors.
- Implemented social media recruitment program at the Mayo Clinic.
- Managed the Sarcoma team and other therapeutic areas; Cardiology/Vascular diseases (Hypertension), Digestive System (Crohn's disease), Genitourinary (Nephritis and Nephropathy), Hematology/Oncology (Multiple myeloma, Prostate cancer, Sarcoma, Solid Tumor), Nervous System (Alzheimer's disease, Myasthenia gravis), and Transplant (Bone Marrow transplant, Liver Transplant, Stem Cell Transplant) through the implementation, maintenance, and completion process of over 30 protocols.
- Facilitated site qualification visits (SDVs) and site initiation visits in collaboration with external sponsor/CROs for investigational new drug (IND), device trials.
- Utilized the most up to date common rule good clinical practice (GCP) guidelines to prepare institutional review board (IRB) applications, compose informed consent forms (ICFs) and submit to all required ancillary committees within a timely manner.
- Analyzed sponsor budget and contract documents to ensure accurate budget builds and avoid overspending related to intramural, federal foundation, and industry funded studies.
- Collaborated with internal members of the study team along with external affiliates of pharmaceutical companies and / or clinical research organizations to meet enterprise activation deadlines.
- Prepared research budgets to provide financial forecasting of anticipated revenues and expenditures for phase I-IV clinical trials.
- Implemented a wide variety of quality improvement initiatives by updating policies, designing workflows, and performing quality assurance (QA) assessments of all billable CPT codes included with the compiled research budgets.
Clinical Research Coordinator
Mayo Clinic
07.2014 - 07.2015
- Maintained compliance with protocols covering patient care and clinical trial operations, with minimal direction from the Principal Investigator and / or supervisor.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Followed informed consent processes and maintained records.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Worked effectively in fast-paced environments.
- Organized and detail-oriented with a strong work ethic.
- Ensured implementation of research protocols after institutional review board approval and provides information as appropriate for progress reports.
- Executed the screening and enrolling of research subjects.
- Coordinated monitors research activities and subject participation.
- Identified, reviewed, and reported adverse events, protocol deviations, and other unanticipated problems.
Managed, monitored, and reported research data to maintain quality and compliance. - Executed administrative and regulatory duties related to the study as appropriate.
Laboratory Support Service Technician / Lead Train
Mayo Clinic
04.2013 - 07.2014
- Provided a wide range of services in clinical, hospital, and research- based laboratories.
- Was responsible for varied laboratory testing, scheduling/billing functions, and phlebotomy.
- Ensured that all services were carried out according to Mayo Clinic Laboratory Department SOP.
- Interacted with the patients, family, physicians, allied health staff, and visitors as a professional member of the laboratory team.
- Trained lab personnel in centrifuge operations, specimen prioritization, specimen receiving and processing, collection and recollection of specimens and the processing of stored serum.
Hospital Corpsman
U.S. Navy
12.1992 - 04.2013
- 20 years of experience working in different healthcare settings, hospital, acute care clinic, and emergency departments.
- Extensive knowledge of health care administration and experienced with coordination of all levels of staffing to ensure compliance with local and regulatory healthcare policies and procedures.
- As clinic supervisor, scheduled, trained and evaluated 30 personnel including nursing, ancillary, and administrative staff in support of a ten-physician primary care facility.
- Outstanding communication, presentation and interpersonal skills and excels in developing and maintaining effective relationships with staff, senior management, and patients.
- Increased employee retention by focusing on continuing education, growth, team building, and recognition programs.
- Managed annual fiscal budget over $250,000.00 and responsible to oversee the inventory and maintenance of all major medical equipment.
- Maintained safety records and training of 85 personnel from various medical platforms to ensure operational readiness at all times.
- Collected and analyzed patient satisfaction data resulting in numerous quality and safety improvement initiatives which increased patient satisfaction and compliance with patient safety goals.
- Developed a mentorship programs at several medical facilities to ensure junior personnel received adequate supervision and hands-on experience providing quality care to the patients.
- Highly developed critical thinking and problem-solving abilities, enabling efficient decision making in high stress environments and situations.
- Interacted well with patients and staff of varied backgrounds and highly successful at managing diverse projects, conflict resolution, and maintaining situational awareness.
- Received numerous awards for outstanding patient care and customer satisfaction.
Performed all medical duties independent of a medical officer. - Provided education to staff on diagnostic services, advanced first aid, basic life support and nursing procedures.
- Lead 50 sailors in the triage, treatment, and medical evacuation of over 400 patients in the aftermath of the earthquake that hit Haiti in 2010.
Education
Bachelor of Science - Health Sciences
Toro University
Cypress, CA05-2008
Skills
- Regulatory Requirements
- Documentation Requirements
- Site Management
- Protocol Understanding
- Trial Oversight
- Regulatory Knowledge
- Client Satisfaction
- Vendor Electronic Systems
- Monitoring Visits
- Site Selection
- Site and Study Management
- Good Clinical Practice
- Communication
Timeline
Senior Clinical Research Associate
Parexel
04.2023 - Current
Senior Clinical Research Associate
Syneos Health
04.2022 - 03.2023
Clinical Research Associate II
PPD Development
02.2022 - 04.2022
Senior Country Approval Specialist
PPD Development
02.2021 - 03.2022
Clinical Research Associate
IQVIA
03.2019 - 02.2021
Research Protocol Specialist
Mayo Clinic
07.2015 - 02.2019
Clinical Research Coordinator
Mayo Clinic
07.2014 - 07.2015
Laboratory Support Service Technician / Lead Train
Mayo Clinic
04.2013 - 07.2014
Hospital Corpsman
U.S. Navy
12.1992 - 04.2013
Bachelor of Science - Health Sciences
Toro University
Therapeutic Areas
Therapeutic Areas:
- Hematology/Oncology: Adult Sarcoma 7 yrs, Carcinoma (5 yrs), Adult Prostate Cancer: (5 yrs), Adult and pediatric Solid tumors: (7 yrs), Multiple myeloma (4 yrs), Sickle Cell Disease: (1yr)
- Nervous System: Alzheimer's (7 yrs), Myastenia gravis (3 yrs)
- Cardiology/Vascular diseases: Hypertension (2yrs)
- Digestive System: Crohn's disease: (2 yrs)
- Genitourinary: Nephritis and Nephropathy: (4 yrs)
- Rare Disease (2yrs)
- Vaccine: COVID-19 (1 yr)