Summary
Overview
Work History
Education
Skills
Quote
Languages
Timeline
StoreManager

Maria "Leticia" Martinez

Clinical Research Professional
San Antonio,TX

Summary

Experienced clinical research professional with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excel in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.

Successfully managed clinical studies in accordance with ICH/GCP, regulatory compliance, protocol requirements, and company SOPs.

Experience with CTMS, eTMF, and multiple EDC systems.

Familiar with Microsoft Word, Excel, and Power Point.

Familiar with medical / scientific terminology.

Conducted phase II - IV clinical studies in the following therapeutic areas: Age-associated Memory Impairment, Alzheimer disease, Anxiety, Bacterial Vaginosis, Binge-eating disorder, COVID-19 treatment, Consumer product testing, Depression, Diabetes, Dyslipidemia, Erectile dysfunction, Endometriosis, Head lice, Herpes Simplex Labialis, Hypertension, Low-Testosterone, Urinary Incontinence, Major Depressive Disorder, Migraine, NASH/NAFL (Non-alcoholic fatty liver), Obesity (Weight loss), Onychomycosis, Osteoarthritis, Vaccine studies (Covid, Influenza, Hepatitis, and Shingles), Vaginal Atrophy.

Overview

17
17
years of professional experience
3
3
Languages

Work History

Senior Clinical Study Manager

Care Access Research
12.2022 - 03.2023
  • Due to company layoffs on 12/1/2022, Manager role was eliminated, and I was offered the opportunity to return to my previous position of Sr. Study Manager.
  • Monitored study progress closely, identifying potential risks and proactively addressing issues to maintain project timelines.
  • Created comprehensive training materials for staff members, enhancing their understanding of protocol requirements and increasing adherence rates.
  • Presented updates on study progress to senior leadership, highlighting key milestones and challenges encountered.
  • Continually assessed emerging trends in the field of clinical research management to inform future strategy decisions.
  • Mentored junior team members in best practices for managing clinical trials effectively.
  • Utilized cutting-edge technology platforms to manage data efficiently, leading to more accurate results and faster decision-making processes.
  • Collaborated with key stakeholders to establish priorities and allocate resources effectively, optimizing the overall study timeline.
  • Maintained open communication channels with all team members, fostering a positive work environment conducive to achieving shared goals.
  • Worked with principal investigators and sponsors to facilitate daily trial activities and comply with research protocols.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Led and managed 8 research sites to ensure the timelines of 3 ongoing protocols were being met.
  • Facilitated weekly meetings with site staff (CRCs) and PIs to report study progress, quality concerns, and issue resolution.
  • Proactively identified challenges and recommended action plans to prevent quality issues and delays in patient enrollment.
  • Participated in the implementation of new clinical trials, and tracked study progress.
  • Engaged in frequent communications with cross-functional teams to ensure timely clinical trial implementation and execution.
  • Provided as-needed training sessions/mentoring to CRCs and Study Managers.
  • Developed and maintained a rapport with sponsor representatives, CROs, and vendors.
  • Professionally represented my employer through effective verbal and written communication with all stakeholders.
  • Led site staff with patience and compassion while communicating a sense of urgency.
  • Championed patient safety by implementing rigorous monitoring procedures and promptly addressing any concerns or adverse events.

Manager / Study Management

Care Access Research
06.2022 - 12.2022
  • Responsible for managing a team of Study Managers (SM) to ensure their success in overseeing sites.
  • Communicated and collaborated with Director of SMs to adequately assign SMs to clinical trials, Principal Investigators, and facilities to ensure proper SM support.
  • Engaged with SM team at least weekly to stay abreast of site status, challenges, and to provide moral support.
  • Performed quality assurance to ensure clinical trial site preparedness.
  • Engaged in quality control of ongoing studies; notified CRC managers of issues discovered, and worked at building the site staff’s knowledge of research.
  • Ensured SMs completed all trainings and stayed on task with preparations for study start-up, and study maintenance.
  • Provided as-needed mentoring and training.
  • Maintained understanding of project scope, milestones, and goals to achieve highest quality results.
  • Managed and motivated employees to be productive and engaged in work.

Senior Clinical Study Manager

Care Access Research
12.2021 - 06.2022
  • Oversaw all clinical trial related operations, at multiple sites, performed by the Decentralized Clinical team.
  • Ensured all work was completed with a strong emphasis on PI oversight, study protocol requirements, and company SOPs.
  • Led a team of 5 Study Managers while preparing for new studies.
  • Delegated duties as needed.
  • Emphasized a team culture of communication and collaboration.
  • Served as the main point of contact for the Principal Investigator (PI), Clinical Research Associates(CRA), and the facilities.
  • Tracked study progress and proactively escalated project-related issues, including those related to time and quality, to the key internal stakeholders to ensure the timely resolution of issues.
  • Managed unit trackers for billable procedures
  • Efficiently performed QC on source documents prior to source implementation.
  • Facilitated weekly PI meetings to present study progress/status/concerns.
  • Mentored new Study Managers and collaborated with Director of SMs to address performance concerns.
  • Offered recommendations for additional assistance if needed.
  • Assisted the sites with preparation for Remote Monitoring visits, attended CRA calls and followed up with sites to ensure prompt resolution of action items.

Clinical Study Manager

Care Access Research
12.2020 - 12.2021
  • Successfully performed the demands of the Study Manager role with minimal supervision.
  • Coordinated operations at six sites at the decentralized site level (DCT) ensuring that processes were in place for clinical staff and Principal Investigators to effectively execute a Covid treatment trial.
  • Maintained frequent contact with the deployment team, as they planned travel for research team, to ensure visits were conducted within protocol-specified windows.
  • Provided guidance (as-needed training/mentoring) to the research team (Travel staff) to ensure they were adequately prepared to conduct protocol required procedures prior to their arrival at facilities.
  • Assisted research staff with resolution of unexpected challenges.
  • Maintained frequent contact with Principal Investigators to document PI oversight.
  • Participated in remote monitor visits with CRAs and resolved all outstanding items; performed quality control on source documents that were completed and uploaded (to Study Hub) by research staff.

Clinical Research Coordinator II

Synexus/AES Clinical Research
08.2006 - 11.2020
  • Company Overview: now Thermo Fisher
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Performed study procedures, i.e Vital signs, ECGS, labs, per study protocols.
  • Entered all collected data and closed queries in a timely manner.
  • Proficient in various electronic data capture (EDC) systems.
  • Proficient in various eDiary and eTablet processes, i.e Clinical Outcome Assessments / Patient-Reported Outcomes.
  • Conducted study procedures while prioritizing compassionate patient care and satisfaction.
  • Attended investigator meetings, maintained contact with CRAs, and resolved all outstanding items.
  • Assessed patients' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
  • Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
  • Worked with principal investigators 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.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Followed informed consent processes and maintained records.
  • Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
  • Directed site initiation visits, establishing key partnerships with local healthcare providers to facilitate successful trial implementation.
  • Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
  • Upheld high quality standards, data integrity, and patient safety.
  • Received commendation for outstanding documentation practices.
  • Site was well known for its excellent execution of study protocols.

Education

Bachelor of Arts - Psychology

University of Texas At San Antonio
San Antonio

Skills

Fibroscan technician certification

Quote

"I can do things you cannot. You can do things I cannot. Together we can do great things."
Mother Teresa

Languages

English
Native or Bilingual
Spanish
Native or Bilingual
Italian
Elementary

Timeline

Senior Clinical Study Manager

Care Access Research
12.2022 - 03.2023

Manager / Study Management

Care Access Research
06.2022 - 12.2022

Senior Clinical Study Manager

Care Access Research
12.2021 - 06.2022

Clinical Study Manager

Care Access Research
12.2020 - 12.2021

Clinical Research Coordinator II

Synexus/AES Clinical Research
08.2006 - 11.2020

Bachelor of Arts - Psychology

University of Texas At San Antonio

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Maria "Leticia" MartinezClinical Research Professional