Clinical Research Specialist

Job Title: Clinical Research Specialist

Job Description:

We are seeking a highly motivated and detail-oriented Clinical Research Specialist to join our team. As a Clinical Research Specialist, you will play a pivotal role in the planning, execution, and monitoring of clinical research studies. This position involves working closely with clinical research coordinators, investigators, and other healthcare professionals to ensure the successful completion of clinical trials.

Key Responsibilities:
• Study Management: As a Clinical Research Specialist, you will oversee the entire lifecycle of clinical trials, including study design, protocol development, and implementation. You will ensure that all study activities are conducted according to regulatory guidelines and ethical standards.
• Data Collection and Analysis: Your role will involve the collection, analysis, and management of clinical data. You will ensure the accuracy and integrity of data collected during clinical research studies, which is crucial for the validity of research findings.
• Regulatory Compliance: Ensuring compliance with regulatory requirements and guidelines is a core responsibility of the Clinical Research Specialist. You will be responsible for preparing and submitting regulatory documents, monitoring study progress, and addressing any issues that arise.
• Participant Interaction: You will be involved in recruiting and interacting with study participants. This includes obtaining informed consent, conducting interviews, and ensuring that participants adhere to study protocols.
• Collaboration: As a Clinical Research Specialist, you will work closely with cross-functional teams, including clinical research coordinators, data managers, and investigators. Effective communication and teamwork are essential for the successful execution of clinical trials.
• Training and Mentorship: You will provide training and support to clinical research staff and ensure that all team members are knowledgeable about study protocols and regulatory requirements.
• Documentation: Maintaining comprehensive and accurate documentation of all study-related activities is critical. As a Clinical Research Specialist, you will be responsible for preparing and maintaining study files, reports, and other documentation required for audits and inspections.

Required Qualifications:
• Educational Background: A Bachelor's degree in life sciences, nursing, or a related field is required. A Master's degree or higher in a relevant discipline is preferred.
• Experience: At least 3 years of experience in clinical research or a related field. Experience with clinical trials, regulatory submissions, and data management is highly desirable.
• Certifications: Certification from a recognized clinical research organization, such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA), is preferred.
• Skills: Strong analytical skills, attention to detail, and proficiency in clinical research methodologies are essential. Familiarity with clinical trial management systems and data analysis software is required.
• Communication: Excellent verbal and written communication skills are necessary for interacting with study participants, team members, and regulatory bodies.
• Organizational Abilities: Strong organizational skills and the ability to manage multiple projects simultaneously are crucial for the success of the role.

Benefits:
• Competitive Salary: A competitive salary package based on experience and qualifications.
• Health and Wellness: Comprehensive health insurance plans, including medical, dental, and vision coverage.
• Retirement Plans: Access to retirement savings plans with employer contributions.
• Professional Development: Opportunities for continuing education and professional development in the field of clinical research.
• Work-Life Balance: Flexible working hours and paid time off to support work-life balance.
• Supportive Environment: A collaborative and supportive work environment with opportunities for career growth and advancement.

In summary, the Clinical Research Specialist is a critical role in ensuring the success of clinical research studies. The position requires a combination of technical expertise, regulatory knowledge, and strong interpersonal skills. If you are passionate about advancing medical science and have a proven track record in clinical research, we encourage you to apply for this exciting opportunity.

United States
Colorado
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