Position Title: Study Coordinator
Location: Austin, TX
Compensation: 75K - 80K base
Full time - Direct Hire

KNOWLEDGE:

• Understanding of research methodologies, study design, and data collection procedures
• Familiarity with regulatory requirements, ethical guidelines, and Good Clinical Practice (GCP) standards.
• Knowledge of relevant medical terminology and basic understanding of disease processes.
• Proficiency in using computer applications and software for data management and analysis.

Skills:

• Excellent organizational and time management skills to effectively coordinate multiple study activities and meet deadlines.
• Strong attention to detail to ensure accurate data collection, documentation, and adherence to protocols.
• Effective communication skills to interact with study participants, research team members, and external stakeholders.
• Problem-solving and critical thinking abilities to address study-related challenges and make informed decisions.
• Ability to work independently and as part of a team, collaborating with various professionals in a research environment.
• Proficiency in using electronic data capture systems, database management, and statistical software.

ABILITIES:

• Ethical conduct and integrity to ensure participant confidentiality, privacy, and informed consent.
• Flexibility and adaptability to handle unexpected changes and adjust study procedures accordingly.
• Strong interpersonal skills to establish rapport with study participants and build professional relationships with colleagues.
• Attention to detail and accuracy in data collection, entry, and analysis.
• Ability to maintain composure under pressure and manage competing priorities.
• Compliance-oriented mindset to adhere to regulatory guidelines and institutional policies.

EDUCATION AND EXPERIENCE:

• A bachelor’s degree in a relevant field, such as life sciences, healthcare, nursing, psychology, or public health, is required.
• 3-5 years experience in clinical research. This should include performing informed consent, determining study eligibility, and managing study records.
• Familiarity with research ethics, regulations, and guidelines, such as the International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP) standards required.
• Knowledge of 21 CFR 1271 preferred.
• Experience with data management, including data collection, entry, and quality control.
• Certification in Clinical Research or a similar professional certification is preferred (ACRP or SOCRA).
• Familiarity with electronic medical record (EMR) systems and other research-related software platforms is advantageous.
• CITI training within 90 days of hire.
  

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WHAT YOU’LL DO

The role of a Study Coordinator involves ensuring the smooth and efficient execution of research protocols while adhering to ethical and regulatory guidelines.

RESPONSIBILITIES

• Study Planning and Design: Collaborate with principal investigators and research teams to develop study protocols and research plans. Assist in identifying study participants or subjects and determining eligibility criteria. Contribute to the development of data collection tools, case report forms, and study materials.
• Study Coordination: Coordinate and schedule research participant visits, procedures, and assessments. Assist in obtaining informed consent from study participants and ensure compliance with regulatory requirements and ethical guidelines. Collect and maintain accurate and complete study-related data, including medical records, laboratory results, and participant demographics. Monitor and document participants’ adherence to study protocols and provide appropriate support and reminders. Coordinate the shipment and handling of research samples and ensure proper storage and documentation.
• Regulatory Compliance and Ethics: Ensure compliance with local, national, and international regulations, guidelines, and ethical standards. Assisted in preparing and submitting necessary regulatory documents, such as Institutional Review Board (IRB) applications, annual reports, and amendments. Maintain study-related documentation, including regulatory files, study logs, and participant records.
• Collaboration and Communication: Serve as a liaison between investigators, research teams, study participants, and external organizations. Coordinate meetings, site visits, and conference calls with collaborators, sponsors, and study monitors. Provide regular updates and reports to principal investigators, sponsors, and regulatory authorities as required. Collaborate with other study coordinators, research nurses, and clinical research associates to ensure effective study implementation.
• Data Management and Quality Assurance: Ensure accurate and timely data collection, entry, and verification. Perform data cleaning, quality control checks, and resolve data discrepancies. Maintain data confidentiality and security in accordance with applicable regulations and institutional policies. Assist in the analysis and interpretation of study data as needed.
• Training and Education: Train and educate study team members and other coordinators on study protocols and procedures. Conduct study-related training sessions for clinical site staff and study participants.