Clinical Research Coordinator

Winaxis LLC; Dallas (TX); Vor Ort; USD 60.000 - 90.000; Vollzeit

Zusammenfassung

Winaxis LLC is seeking a Clinical Research Coordinator (CRC) to oversee clinical trials per study protocols, GCP guidelines, and regulatory requirements. You will recruit participants, document data, and safeguard safety and data integrity.

You will coordinate day-to-day study activities, ensure protocol compliance, obtain informed consent, schedule visits, maintain regulatory files, and support sponsor visits and inspections in hospital and research settings.

Qualifikationen

• Bachelor's degree in Life Sciences or related field.
• Prior clinical research or trial coordination experience preferred.
• GCP certification an advantage.

Aufgaben

• Coordinate and oversee day-to-day activities related to assigned clinical studies.
• Review study protocols and ensure activities comply with protocol requirements.
• Recruit, screen, and enroll eligible study participants.
• Obtain and document informed consent from participants.
• Schedule participant visits and coordinate assessments and follow-ups.
• Collect, document, and maintain study data in CRFs and EDC systems.
• Maintain essential regulatory documents and study records.
• Monitor participant safety and report adverse events per timelines.
• Coordinate with investigators, sponsors, CROs, labs, and stakeholders.
• Prepare for sponsor monitoring visits, audits, and regulatory inspections.
• Adhere to GCP, policies, and local and international regulations.
• Track study timelines, recruitment targets, and milestones.
• Assist with initiation, amendments, close-out, and archiving of documents.
• Maintain confidentiality of participant information.

Kenntnisse

Clinical trials

ICH-GCP

Organizational skills

Communication

Attention to detail

MS Office

EDC systems

Independent worker

Team collaboration

Problem solving

Ausbildung

Bachelor's degree in Life Sciences

Tools

EDC software

Study management software

Jobbeschreibung

Job Summary:

The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical trials in accordance with study protocols, Good Clinical Practice (GCP) guidelines, institutional policies, and applicable regulatory requirements. The role involves participant recruitment, study documentation, data collection, and ensuring the smooth execution of research activities while safeguarding participant safety and data integrity.

Key Responsibilities:

• Coordinate and oversee day-to-day activities related to assigned clinical studies.
• Review study protocols and ensure all trial activities are conducted in compliance with protocol requirements.
• Recruit, screen, and enroll eligible study participants according to inclusion and exclusion criteria.
• Obtain and document informed consent from study participants prior to study procedures.
• Schedule participant visits and coordinate study assessments, procedures, and follow-ups.
• Collect, document, and maintain accurate study data in Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems.
• Maintain essential regulatory documents, investigator site files, and study records.
• Monitor participant safety by identifying, documenting, and reporting adverse events and serious adverse events in accordance with regulatory timelines.
• Coordinate with Principal Investigators, sponsors, Contract Research Organizations (CROs), laboratory personnel, and other study stakeholders.
• Prepare for and support sponsor monitoring visits, audits, and regulatory inspections.
• Ensure adherence to Good Clinical Practice (GCP), institutional policies, and applicable local and international regulations.
• Track study timelines, recruitment targets, and protocol milestones.
• Assist with study initiation, amendments, close-out activities, and archiving of study documents.
• Maintain confidentiality of participant information and research data at all times.

Required Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Medicine, or a related healthcare field.
• Prior experience in clinical research or clinical trial coordination is preferred.
• Certification in Good Clinical Practice (GCP) is an advantage.

Required Skills:

• Strong understanding of clinical trial processes and research ethics.
• Knowledge of ICH-GCP guidelines and regulatory requirements.
• Excellent organizational and time-management skills.
• Strong verbal and written communication abilities.
• Attention to detail and accuracy in documentation.
• Proficiency in Microsoft Office applications and EDC systems.
• Ability to work independently and collaboratively within multidisciplinary teams.
• Effective problem-solving and interpersonal skills.

Working Conditions:

Work is typically performed in hospitals, research institutions, academic medical centers, or clinical research organizations. May require flexibility to accommodate participant schedules and sponsor visits.