Pinnacle Clinical Research · 1 month ago
Clinical Research Coordinator
Brownsville, TX
Full-time
Onsite
New Grad, Entry LevelPinnacle Clinical Research is committed to driving innovation and advancing medical knowledge through rigorous clinical research. They are seeking a Clinical Research Coordinator responsible for managing day-to-day operations of clinical trials, assisting in project planning, and ensuring compliance with study protocols and regulatory requirements.
Clinical TrialsHealth CareHospitalMedical
Responsibilities
Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Project Manager, and Director of Clinical Research Operations
Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures
Complete study directed assessments with patients which include, but not limited to, informed consent, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment
Create and complete study related documents and new study preparation
Function as a liaison with pharmaceutical sponsors and external vendors
Prepare for study monitor visits (onsite or remote), audit inspections, etc
Respond to internal and external requests for information in a timely manner
Perform subject screening and recruitment
Contribute to data management for research projects
Identify opportunities to improve patient care and satisfaction
Conduct patient-facing encounters with compassion, empathy, and thoroughness
Must be able to review medical records against Inclusion/exclusion criteria to identify potential subjects
Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose
Obtains and documents adverse event data on appropriate forms
Ensure source documents are transcribed to EDC platform per protocol on a timely manner
Ensure EDC queries are answered within the required time set by the Project Manager or Data Management team
Resolve other study-related queries within a reasonable time set by the Project Manager or Data Management team
Interact with internal and external personnel such as physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients
Coordinate multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume
Attends the investigator’s meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by Monitors or Sponsor representatives as appropriate
Ensure that electronic case report forms are completed
Create memos, emails, and letters related to study activities
Create and maintain reports and/or spreadsheets as requested
Ensure that all patient data is entered into the clinical trial management system in a timely manner
Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections
Responsible for reporting safety information to all regulatory agencies
Understand the aspects of Regulatory and IRB requirements for studies
Performs quality checks on source documents specific to the study
Assist with the Corrective Action Preventive Action Plan (CAPA) process as needed
Qualification
Required
Highschool diploma or general education degree (GED) required
Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS
Must have strong knowledge of ICH/GCP guidelines
Must complete CITI training before interacting with participants and must re-certify every 3 years
Must be trained and certified in administration of Fibroscan, training provided during onboarding
Must have basic life support (BLS) training, provided during onboarding
Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time
Strong written and oral communication skills
Knowledge of basic medical terminology
Possess impeccable integrity and personal and professional values that are consistent with PCR's high standards and mission
Comply with the company policies, code of ethics, and guiding values always
Proficient in Spanish and English required
Valid driver's license and insurance
Preferred
Bachelor's Degree in scientific area of study preferred or equivalent combination of education, training, and experience, or promotion internally from Research Assistant role
Benefits
401k
Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
3 weeks of paid time off
14 paid company holidays
Scrub uniform voucher (specific positions apply)
And more!
Company
Pinnacle Clinical Research
Pinnacle Clinical Research conducts clinical trials in hepatology and gastroenterology.
Founded in 2016
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2023-01-10Acquired
Leadership Team
Rashmee Patil
Chief Medical Officer and Principal Investigator
Terri Burghart
Regional Director - Central Texas
Recent News
2025-09-24
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