Clinical Research Coordinator

1 week ago

Lufkin, Texas, United States SiteBridge Research, Inc. Full time
Job Title: Clinical Research Coordinator

Job Summary:

We are seeking a highly motivated and organized Clinical Research Coordinator to join our team at SiteBridge Research, Inc. The successful candidate will be responsible for coordinating and facilitating daily clinical trial activities, ensuring compliance with ICH/GCP guidelines, and maintaining operational excellence at our research site.

Responsibilities:

  • Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines
  • Assist in the set-up and start-up of research sites to prepare for clinical trials
  • Lead oversight of pre-study, site initiation, and close-out visits with sponsors or CROs
  • Consult with site leads, sponsors, and CROs to determine the best recruitment practices for sites and trials
  • Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies
  • Arrange screening and recruitment of potential study participants by scheduling visits to establish informed consent and perform intake assessments according to protocols
  • Create and maintain all essential documents and records related to the study
  • Act as a point of reference for study participants by answering questions and keeping them informed on the study's progress
  • Oversee and/or manage the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed
  • Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results
  • Direct the request, collection, labeling, storage, or shipment of interventional products
  • Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems
  • Monitor the enrollment status of participants at the site for each specific clinical study
  • Operate as primary contact for sponsors/CROs to schedule and coordinate site visits and answer queries
  • Participate in meetings (investigator meetings, site trainings, etc.) and seminars to update knowledge of clinical research and related issues
  • Prepare or participate in quality assurance audits and inspections performed by sponsors/CROs, regulatory authorities, or exclusively designated review groups
  • Provide regular updates to site clinical investigators and clinical/site ops leads on study progress related to recruitment, compliance, and other study-related matters

Qualifications & Required Experience:

  • Bachelor's degree preferred in a relevant life science discipline; LVN or RN is preferred; certification as CCRC/CCRP is a plus
  • 2+ years of previous experience working in a clinical setting; number of years of clinical site/trials experience will determine position level
  • Working knowledge of FDA & ICH GCP regulations and guidelines
  • Strong preference for experience with late phase and observational clinical research
  • Managing necessary clinical study and staff records related to clinical study activities including: case report forms, drug dispensation records, etc.
  • Preparing advertising and other educational materials and conducting campaigns to recruit and enroll subjects
  • Preparing trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports
  • Assessing risk factors in study protocols such as sample collection procedures, data management issues, and possible subject threats
  • Clinical and laboratory skills, including the ability to perform phlebotomy and process samples are required
  • Detail-oriented and meticulous in all aspects of work
  • Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
  • Superior organizational and time management skills
  • Capable of working independently with minimal supervision and as part of a team
  • Understanding of medical terminology as well as standard clinical procedures and protocol
  • Ability to lift approximately 20 pounds for a short period and capable of standing for extended periods of time

Additional Qualifications:

  • Strong Project Management skills including risk assessment and contingency planning
  • High level of collaboration, customer-oriented awareness, and focus
  • Skilled with standard computer programs including the MS Office suite
  • Strong interpersonal and written and verbal communication skills
  • Therapeutic experience in alignment with primary protocol(s) and site practice preferred
  • Some travel may be required

Pay Range:

The combined pay range for this role is $26 - $36/hour. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.

SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills, and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements, and individual qualifications and performance.

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