Shannon Williams
Metairie,LA
Summary
Dedicated clinical research coordinator experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Prepared to offer several years' experience in the field and take on a fast-paced position. Prior roles illustrated high standards of ethics while ensuring accuracy and quality in research outcome.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Ochsner Clinical Foundation
New Orleans, LA
06.2023 - Current
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Assisted in preparing periodic reports summarizing progress of clinical studies.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Coordinated investigator meetings, conference calls, and site initiation visits as needed.
- Organized, analyzed and modeled study data.
- Prepared informed consent forms for review by ethics committees.
- Educated participants on studies and anticipated outcomes.
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Provided training to study staff on protocol requirements and GCP regulations.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Collected, processed and delivered specimens from trial participants.
- Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Conducted screening interviews to determine eligibility of possible subjects.
- Developed case report forms for data collection at investigational sites.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Monitored patient safety during clinical trials according to established guidelines.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Monitored subject enrollment and tracked dropout details.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Developed and maintained accurate and timely study databases.
- Provided support and guidance to colleagues to maintain a collaborative work environment.
- Managed inventory and supplies to ensure materials were available when needed.
- Managed time effectively to ensure tasks were completed on schedule and deadlines were met.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
- Approached customers and engaged in conversation through use of effective interpersonal and people skills.
Lead Clinical Research Coordinator
DePaul Center for Clinical Research/ Objective Hea
New Orleans , LA
03.2021 - 08.2023
- Conducted training sessions for research staff on Good Clinical Practices.
- Reviewed patient charts for accuracy prior to data entry into the database.
- Conducted screening interviews to determine eligibility of possible subjects.
- Maintained accurate records of all correspondence related to clinical trial activities.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Kept patient care protocols and clinical trial operations in compliance.
- Gathered and reviewed study data.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Took vital signs and collected medical histories as part of study protocols.
- Mentored and provided ongoing support to research team, providing training in research design and conduct.
- Performed ongoing monitoring visits at participating sites according to established schedules.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Monitored subject enrollment and tracked dropout details.
- Generated timely responses to queries from sites regarding protocol-related information.
- Ensured appropriate documentation was completed by investigators in accordance with ICH and GCP guidelines.
- Developed and maintained clinical trial documents, such as protocols, case report forms, and informed consent forms.
- Researched literature pertaining to specific therapeutic areas as needed.
- Educated participants on studies and anticipated outcomes.
- Provided support in preparation for FDA inspections including review of relevant documents.
- Tracked adverse events reports from participating sites throughout the course of each trial.
- Prepared monthly progress reports outlining key milestones achieved during the month.
- Assisted in development of procedures for efficient collection, analysis, and reporting of data.
- Collaborated with project managers to identify potential issues that could affect the timeline of a study.
- Utilized various software and tools to streamline processes and optimize performance.
- Managed time effectively to ensure tasks were completed on schedule and deadlines were met.
- Prioritized and organized tasks to efficiently accomplish service goals.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
- Worked effectively in team environments to make the workplace more productive.
- Provided excellent service and attention to customers when face-to-face or through phone conversations.
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
- Managed inventory and supplies to ensure materials were available when needed.
- Identified needs of customers promptly and efficiently.
Clinical Research Coordinator
Benchmark Research
Metairie, LA
03.2018 - 08.2023
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Prepared informed consent forms for review by ethics committees.
- Educated participants on studies and anticipated outcomes.
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Provided training to study staff on protocol requirements and GCP regulations.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Collected, processed and delivered specimens from trial participants.
- Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Conducted screening interviews to determine eligibility of possible subjects.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Monitored patient safety during clinical trials according to established guidelines.
- Monitored subject enrollment and tracked dropout details.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Reviewed CRFs for completeness and accuracy before database entry.
- Developed and maintained accurate and timely study databases.
- Conducted routine visits to research sites to ensure compliance with protocol requirements.
- Gathered and reviewed study data.
- Took vital signs and collected medical histories as part of study protocols.
- Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, regulations, guidelines.
- Kept patient care protocols and clinical trial operations in compliance.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
- Utilized advanced technical skills and expertise to troubleshoot complex problems and implement solutions.
- Worked effectively in team environments to make the workplace more productive.
- Completed day-to-day duties accurately and efficiently.
- Demonstrated strong problem-solving skills, resolving issues efficiently and effectively.
- Conducted comprehensive research and data analysis to support strategic planning and informed decision-making.
- Approached customers and engaged in conversation through use of effective interpersonal and people skills.
- Recognized by management for providing exceptional customer service.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
- Managed time effectively to ensure tasks were completed on schedule and deadlines were met.
- Worked with cross-functional teams to achieve goals.
LPN Charge Nurse
Cupertino Healthcare and Rehabilitation Center
Cupertino, CA
10.2016 - 02.2018
- Communicated with patients with compassion while keeping medical information private.
- Communicated effectively with patients and loved ones to explain diagnoses, treatment options and procedures.
- Worked as part of healthcare team to assess patient needs, plan and modify care and implement interventions.
- Coordinated shift schedules and assigned duties to LPNs and CNAs based on qualifications.
- Conducted regular training sessions for new hires or existing staff members on proper clinical procedures or techniques.
- Monitored medication administration for accuracy, compliance, and effectiveness of treatment plan.
- Communicated effectively with patients, families, colleagues, and other healthcare professionals.
- Coordinated discharge planning activities including arranging follow-up appointments for discharged patients.
- Educated clients, patients and caregivers on medical diagnoses, treatment options, chronic disease self-management and wound management.
- Assisted in developing policies related to infection control practices.
- Observed and reported changes in condition of patients and signs and symptoms of deviations from normal health status.
- Delivered emotional, psychological and spiritual support to patients and families to promote compassionate environment.
- Collaborated with healthcare team to develop individualized care plans for patients.
- Administered medications in accordance with policies and legal limitations.
- Collected biological samples from patients and performed routine lab tests to support diagnosis.
- Evaluated nursing intervention outcomes by conferring with other healthcare team members.
- Evaluated patient care procedural changes for effectiveness and made necessary adjustments.
- Demonstrated excellent communication skills when interacting with patients and families.
- Evaluated patient responses to treatments and interventions and documented progress notes accordingly.
- Directed implementation of improved patient care and documentation methods and procedures to achieve quality objectives.
- Guaranteed exceptional care quality by correctly administering medication, inserting and caring for catheters, dressing and changing wounds and assisting with personal hygiene.
- Administered medications and therapies in accordance with physicians orders.
- Assisted physicians and nurses with special procedures.
- Promoted positive relationships between patients, families, visitors, physicians, nurses, volunteers.
- Maintained accurate medical records and updated them regularly.
- Collaborated with multi-disciplinary staff to improve overall patient care and response times.
- Answered patient calls, identified issues and determined how best to provide assistance within parameters established by facility and supervisor.
- Assessed patients' health conditions and monitored changes in their condition.
- Identified potential problems or risks that could affect patient outcomes.
- Provided patient care plans, treatments, and medications according to physicians' orders.
- Educated patients on conditions, medications and self-care skills.
- Assembled and used catheters, tracheotomy tubes or oxygen suppliers.
- Took temperatures or blood pressures, dressed wounds and provided other basic patient care or treatments.
- Prepared patients for examinations, tests or treatments and explained procedures.
- Maintained strict patient data procedures to comply with HIPAA laws and prevent information breaches.
- Measured and recorded patient height, weight and other vital signs.
- Observed strict confidentiality and safeguarded all patient-related information.
- Educated patients on wound and disease self-management techniques.
- Collaborated with supervisor to prepare nursing assessment summaries and health care plans.
- Documented adverse patient reactions to medications and reported findings to supervisors.
- Documented patient medical histories, current symptoms and vitals.
- Collected blood, urine or sputum from patients to perform routine laboratory tests.
- Addressed patient care needs, collected vitals, dressed wounds and managed catheters.
- Collaborated with multidisciplinary teams to coordinate effective patient care delivery systems.
Clinical Research Coordinator
Golden Shore Medical
S. Pasadena , CA
10.2013 - 07.2017
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Prepared informed consent forms for review by ethics committees.
- Educated participants on studies and anticipated outcomes.
- Provided training to study staff on protocol requirements and GCP regulations.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Conducted screening interviews to determine eligibility of possible subjects.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Monitored patient safety during clinical trials according to established guidelines.
- Monitored subject enrollment and tracked dropout details.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Reviewed CRFs for completeness and accuracy before database entry.
- Conducted routine visits to research sites to ensure compliance with protocol requirements.
- Gathered and reviewed study data.
- Took vital signs and collected medical histories as part of study protocols.
- Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, regulations, guidelines.
- Kept patient care protocols and clinical trial operations in compliance.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
- Prioritized and organized tasks to efficiently accomplish service goals.
- Provided excellent service and attention to customers when face-to-face or through phone conversations.
- Utilized advanced technical skills and expertise to troubleshoot complex problems and implement solutions.
- Completed day-to-day duties accurately and efficiently.
- Demonstrated strong problem-solving skills, resolving issues efficiently and effectively.
- Approached customers and engaged in conversation through use of effective interpersonal and people skills.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
- Managed time effectively to ensure tasks were completed on schedule and deadlines were met.
- Managed inventory and supplies to ensure materials were available when needed.
- Provided support and guidance to colleagues to maintain a collaborative work environment.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
Education
Associate of Science - Nursing
Delgado Community College
New Orleans, LA12-2004
High School Diploma -
Francis T. Nicholls High School
New Orleans, LA05-1988
Skills
- Patient recruitment
- Informed consent preparation
- Adverse event reporting
- Database management
- Effective communication
- Team collaboration
- Regulatory compliance
- Problem solving
- Time management
- Document preparation
- Training development
- Adverse event tracking
- Good clinical practice
- Site management
- Research experience
- Records maintenance
- Informed consent
- Schedule coordination
- Specimen handling
- Participant screening
- Clinical research ethics
- Good clinical practices
- Electronic data capture
- Study protocols
- Scheduling proficiency
- Informed consent process
- Phlebotomy
- Trial oversight
- Research sops understanding
- Informed consent procedures
- Team building
- Clinical Protocol Compliance
- Ethical guidelines adherence
- Time management abilities
Certification
- La CaTS Research Coordinator Training Program for Levels 1-3. February 23, 2024 Level I, April 5, 2024 Level II, and September 20, 2024 Level III.
- ePRO Remote and In-Clinic ePRO Web (Data Entry: R41.4), August 16, 2023.
- Mayo Clinic- IATA Training for Transporting Dangerous Goods. December 3, 2024- December 3, 2026.
- eTraining for Bloodborne Pathogens. (Certificate Number: 203980), November 3, 2022. "OSHA 29 CFR 1910.1030- 2 hrs."
- eTraining for Personal Protective Equipment (Certificate Number: 203973), November 3, 2022. "OSHA 29 CFR 1910.132Subpart I- 2hrs."
- CITI GCP for Clinical Trials with Investigational Drugs and Biologics. (Record ID: 52308000), October 24, 2025- October 24, 2025.
- CITI for Biomedical Research/ Basic Refresher (Record ID: 52308001), October 25, 2022- October 24, 2025.
- BLS: July 20, 2023- July, 31, 2025.
- RQI Healthcare Provider- e-card Code: uv5tqpjbpc8gmmqmpgivhkfp / December 31, 2026.
- History and Ethics of Human Subjects Research: ID# 498, October 25, 2025.
- Informed Consent: ID# 239, October 25, 2026.
- Social and Behavioral Research: ID# 2, ID#5, October 25, 2026.
- Records- Based Research: ID# 15, October 25, 2026.
- FDA- Regulations Related: ID# 12, October 25, 2025.
- Research and HIPPA: ID# 4, December 25, 2025.
- Genetic Research in Human Populations: ID# 6, December 25, 2026.
- Biomedical Research: ID# 1447, October 25, 2025.
- Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Other's in Biomedical Research: ID# 14777, October 25, 2025.
- Research and HIPPA Privacy Protection: ID# 14, October 25, 2025.
- Vulnerable Subjects- Research Involving Workers / Employee: ID# 483, October 25, 2025.
- Avoiding Group Harm- US Research: ID: 14080, October 25, 2025.
- Populations in Research Requiring Additional Consideration and/ or Protectio: ID# 1616680, October 25, 2025.
Affiliations
- SPR001-203-204, Randomized, double- blinded, Placebo- Controlled dose-ranging study to evaluate the efficacy and safety of SPR001 (Tildacerfont), in adult subjects with classic Congenital Adrenal Hyperplasia.
- Protocol C4591001 (COVID-19).
- Protocol MRNA-1273-P301 (COVID-19).
- Protocol GO44296 VI- Roche Cancer Screening Study- A Blood-Based Assay for Cancer Screening, Which Can Lead To Earlier Detection of Cancers, Can Address the Unmet Need of Expanding Cancer Screening and Overcoming The Low Uptake of Screening Amongst Screen- Eligible Population.
- 2021-C4591001: A Phased 1,2,3, Placebo-Controlled, Randomize, Observer Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, Immunogenicity , And Efficacy, And Efficacy of SARS-COV-2 In Healthy Individuals.
- 2020-mRNA-1273-P301, A Phase 3, Randomize, Stratified, Observer-Blind, Placebo Controlled Study to Evaluate the Efficacy, Safety, And Immunogenicity of mRNA- 1273- SARS-COV-2 in Healthy Individual.
Timeline
Clinical Research Coordinator
Ochsner Clinical Foundation
06.2023 - Current
Lead Clinical Research Coordinator
DePaul Center for Clinical Research/ Objective Hea
03.2021 - 08.2023
Clinical Research Coordinator
Benchmark Research
03.2018 - 08.2023
LPN Charge Nurse
Cupertino Healthcare and Rehabilitation Center
10.2016 - 02.2018
Clinical Research Coordinator
Golden Shore Medical
10.2013 - 07.2017
Associate of Science - Nursing
Delgado Community College
High School Diploma -
Francis T. Nicholls High School