Clinical Research Specialist

4 weeks ago

Beckley, United States AtWork Group Full time
Clinical Researcher

*Job Description:*
A Clinical Researcher is a highly trained professional responsible for designing, conducting, and managing clinical trials and research studies. They play a crucial role in the development of new medical treatments, drugs, and therapies. Clinical Researchers collaborate with interdisciplinary teams, including physicians, scientists, and regulatory authorities, to ensure that research protocols are ethically sound, scientifically valid, and comply with regulatory standards.

*Responsibilities:*
1. **Protocol Development:** Design and develop research protocols outlining the objectives, methodology, and ethical considerations of clinical trials.

2. **Patient Recruitment:** Recruit and screen eligible participants for clinical trials, ensuring adherence to inclusion and exclusion criteria.

3. **Data Collection:** Oversee the collection, analysis, and interpretation of data generated during clinical trials, ensuring data integrity and accuracy.

4. **Regulatory Compliance:** Ensure compliance with regulatory requirements, ethics committees, and institutional review boards. Prepare and submit regulatory documents for approval.

5. **Collaboration:** Work closely with multidisciplinary teams, including physicians, statisticians, and laboratory staff, to coordinate and conduct research activities.

6. **Monitoring and Quality Assurance:** Monitor the progress of clinical trials, ensuring they are conducted in accordance with protocols and regulations. Implement quality assurance measures to uphold data integrity.

7. **Adverse Event Reporting:** Manage and report adverse events that may occur during the course of clinical trials, adhering to regulatory reporting requirements.

8. **Documentation:** Maintain accurate and detailed records of study protocols, data collection, and other research-related activities. Prepare reports and publications for scientific dissemination.

9. **Communication:** Collaborate with sponsors, investigators, and research staff to communicate study progress, results, and any issues that may arise during the research process.

10. **Continuous Learning:** Stay abreast of developments in the field of clinical research, including changes in regulations, methodologies, and technological advancements.

*Qualifications:*
- Clinical Research certification preferred, but not required
- Strong understanding of clinical research methodologies and Good Clinical Practice (GCP) guidelines.
- Excellent organizational and project management skills.
- Analytical and critical-thinking skills for data interpretation.
- Effective communication and interpersonal skills.
- Attention to detail and adherence to ethical standards in research.

Clinical Researchers are essential contributors to the advancement of medical knowledge and the improvement of patient care through evidence-based practices.

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