Focused Clinical Research Coordinator well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 18 years of related experience to a challenging new role. Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Willingness to take on added responsibilities to meet team goals. Ability to handle multiple projects simultaneously with a high degree of accuracy
Overview
19
19
years of professional experience
1
1
Certification
Work History
Security Captain
Class Act Security Protection and Training Academy
05.2024 - Current
Train and mentor junior security personnel on emergency response procedures and conflict resolution techniques.
Conduct regular site assessments to identify vulnerabilities and recommend improvements to enhance overall security measures.
Coordinate communication between team members during high-pressure situations, ensuring swift incident management.
Oversee daily operations, optimizing resource allocation for various security assignments across multiple venues.
Evaluate incident reports and feedback
Create detailed incident reports, maintaining accurate records for future reference and analysis.
Ensure the safety of employees and guests through proactive monitoring of security cameras and regular foot patrols.
Review existing security policies regularly, recommending updates as needed based on industry best practices or evolving threats.
Train junior security officers on proper protocols and procedures, leading to a more efficient and effective team.
Provide excellent customer service to visitors while enforcing access control measures, balancing professionalism with vigilance.
Collaborate with senior management to develop and implement strategies to mitigate security risks.
Evaluate security systems and procedures to identify areas for improvement.
Move around different security stations and vital areas to check on officers and adjust workflow to cover changing needs.
Investigate and resolved security breaches to protect organization and corporate assets.
Supervised team of 12 security personnel during shift.
Respond swiftly to security incidents and effectively resolved security issues.
Analyze and investigate incidents alongside functional management and security supervisors.
Coordinate with security personnel or other departments to establish safety of visitors and staff.
Record incident reports with detailed accounts of occurrences.
Maintain strict confidentiality when handling sensitive information pertaining to company assets or personnel matters.
Establish rapport with employees across various departments, fostering a sense of trust in the security team''s capabilities.
Work across multiple security accounts
Conduct weekly briefings and meetings with staff
Clinical Operations Lead
Teckton Research, LLC
08.2023 - 01.2024
Oversaw daily operations of clinical trials. Proactive in communicating with team members ensuring excellent conduct of clinical trials
Scheduled staff, ensuring effective coverage of all business needs
Collaborated with regional Director to ensure site goals were met
Demonstrated ability in leading multiple studies
Led team members in study conduct, including study management and task delegation
Ensured quality and production measures were met
Served as a leader, mentor, and resource for the team
Conducted required training for staff and assessed for competency to perform assigned roles
Ensured that staff communicated well and appropriately with Clinical Research Associates and other sponsor representatives
Collaborated with Executive Director and Recruitment staff to ensure that all study enrollment goals were met
Ensured that staff completed all components of study according to protocol
Ensured coordinator completion of follow up letter open items prior to next Clinical Research associate visit
Ensured clinical research coordinator preparedness for Clinical Research Associate visit, including completion of source documentation readiness, electronic data capture, and query resolution
Ensured coordinators completed regulatory tasks as assigned
Ensured use of latest Informed Consent and use of Protocol Version check system
Supported staffing function by assigning new studies and made sure that assignments were fairly assigned
Engaged in interviewing candidates for open roles
Consistent in communication regarding employee issues, concerns, and opportunities regarding performance and development needs/progress
Mentored junior staff on operational best practices and process improvements.
Conducted regular performance assessments, providing constructive feedback and identifying areas for growth and development among team members.
Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
Collected, arranged, and input information into database system.
Evaluated staff performance and provided coaching to address inefficiencies.
Lead Clinical Research Coordinator
Reify Health
04.2022 - 04.2023
Worked with principal investigators and sponsors to facilitate daily trial activities and comply with research protocols
Supervised and managed employees, sites, and staff for studies, training of staff and employees on protocol adherence, mock visits and retraining of staff when necessary
Developed and implemented training programs for research staff to enhance compliance and operational efficiency.
Coordinated multi-site clinical trials, ensuring adherence to protocols and regulatory standards.
Evaluated site performance metrics, implementing corrective actions to enhance study execution outcomes.
Mentored junior coordinators in best practices for regulatory documentation and trial management processes.
Evaluated emerging technologies and tools essential for enhancing clinical research processes, making recommendations on implementation to improve overall efficiency.
Boosted patient retention rates by fostering strong relationships with participants through clear communication and compassionate care delivery during study visits.
Maintained accurate and up-to-date case report forms and source documents for traceability.
Monitored patient safety throughout clinical trials and reported any adverse events.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Maintained compliance with protocols covering patient care and clinical trial operations.
Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
Gathered, processed, and shipped lab specimens.
Followed informed consent processes and maintained records.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Increased patient safety with diligent monitoring, prompt adverse event reporting, and thorough follow-up investigations.
Daily briefings with study managers to ensure continuity of study and progression of study endpoints
Actively screened and enrolled over 800 participants with positive feedback from subjects
Expedited regulatory approval timelines by preparing high-quality submissions, maintaining regular communication with authorities, and promptly addressing queries.
Reduced study deviations through meticulous documentation of informed consent processes, eligibility assessments, and visit details.
Clinical Research Assistant
Digestive Healthcare of Georgia
10.2019 - 03.2022
Plan and coordinate projects that advanced medical treatment, through the broad aim of clinical research trials
Executed multiple duties in clinical drug trials, to include vital signs, IV placement and infusions, subcutaneous injecions, phlebotomy and specimen collections, screening and patient assessments, perform liver Fibroscans, EKG and Holter Monitoring, urine pregnancy and drug screens, administering clinical trial medications and healthcare to study participants as instructed by the Principal Investigator in accordance with the clinical research protocols
Exhibited Analytical, Communication, Time Management, Organizational Skills and Attention to Details in various trials, to include;
Intercept (NASH-Non Alcoholic -Steatohepatitis)
Genfit (PBC)
AMAX (Crohns’s Disease)
AMAP (Ulcerative Colitis)
Guardant (Colorectal)
ALMANAC (Colorectal)
PFIZER (NASH-Non Alcoholic -Steatohepatitis)
CYMABAY (PBC)
Novo-Nordisk (Peripheral Aerial Disease- (PAD) & Type II Diabetes)
ARENA- 206 (EOE)
APD 334 (Ulcerative Colitis)
Collect, recorded and maintained data on source documents with timely completion of Case Report Forms
Promoted good clinical practices in the conduct of clinical investigations
Compliance with trial protocols and regulatory requirements
Responded to and answering of queries of medical monitors and study sponsors
Facilitated in developing source documents for new clinical research projects
Conducted telephone and face to face interviews with potential research patients, also sending emails for follow up visits or correspondence per protocol study
Active recruitment of potential study subjects and assisted lead study coordinator with close-out visits
Attended site initiation visits & site monitor visits in addition to other meetings for various studies
Completed all site training requirements including GCP, IATA, OSHA training, site SOP review and training, and department training
Ensured that all study supplies and kits have been received and documented
Training in several study portals to include: IMEDI-DATA, CRIO, SMARTSTART, STUDYTEAM, ICON, & ELI-LILLY
Respond appropriately and timely with documentation of all AE’s and SAE’s in accordance with protocol guidelines for all studies
IP accountability and compliance with all study protocols as needed
Maintained all subjects binders of documentation and Daily monitoring of IP storage temperatures.
Phlebotomy Site Coordinator
LabCorp, Corporation
08.2011 - 10.2019
Collection of patient samples and other fluids for testing and research purposes
Properly identified patients with updates in CLIA Systems using ID or other documentation of means
Ensure optimal quality in preservation of patient health and quality of samples
Skills with presence of mind, people skills and attention to details
Upkeep of medical records on specimen and fluid testing
Adhere to all relevant health and safety standards in the clinical setting.
Tracked collected specimens by initialing, dating, and noting times of collection
Supervising the day to day functions of the staff and patient service center
Assisted in training and onboarding of new phlebotomist
Provide guidance and support to laboratory personnel
Adhered to HIPAA standards and maintained patient confidentiality in all interactions