Job Summary:

HR Service Jobs is seeking a highly experienced and detail-oriented Senior Clinical Research Associate (CRA) to join our team on a work-from-home contractor basis. As a Senior CRA, you will be responsible for managing clinical trials, ensuring compliance with regulatory standards, and maintaining quality data throughout the research process. This is an excellent opportunity for someone with a passion for clinical research who thrives in a remote work environment. You will collaborate with cross-functional teams to ensure the successful execution of clinical studies.

Key Responsibilities:

• Lead and manage clinical research projects from start to finish, ensuring timely and efficient execution.
• Oversee the preparation, planning, and execution of clinical trials in accordance with ICH-GCP and local regulatory requirements.
• Monitor the progress of clinical trials, conducting regular site visits (virtual) to ensure adherence to protocols, regulatory guidelines, and timelines.
• Collaborate with clinical research teams, investigators, and vendors to ensure that trials are conducted smoothly and efficiently.
• Prepare, review, and submit regulatory documents to ensure compliance with applicable laws and standards.
• Manage data collection and ensure data quality throughout the trial process.
• Provide mentoring and training to junior CRAs and site staff.
• Troubleshoot and resolve any issues related to clinical trials or study sites.
• Ensure effective communication with stakeholders and provide regular progress updates to clients.
• Review and verify the accuracy and completeness of clinical trial documentation.

Required Skills and Qualifications:

• Bachelors degree in Life Sciences, Nursing, or related field. Advanced degrees (e.g., Masters or PhD) are a plus.
• Strong experience (5+ years) in clinical research, with at least 2 years in a senior CRA role.
• In-depth knowledge of clinical trial protocols, regulatory guidelines (GCP, ICH), and applicable local regulations.
• Proven ability to manage multiple projects and deliver on deadlines.
• Strong organizational skills and attention to detail.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a remote team.
• Proficient in the use of clinical trial management systems (CTMS) and related software.
• Willingness to travel (virtually) as needed to meet the needs of the trial.

Experience:

• Minimum of 5 years of experience in clinical research, with at least 2 years in a senior or lead CRA role.
• Experience in managing Phase I-IV clinical trials and a wide range of therapeutic areas.
• Proven track record of success in overseeing clinical trial execution and site management.
• Experience working in a remote or home-based environment.

Working Hours:

• Full-time contract position.
• Flexible working hours with a requirement to be available during standard business hours (Eastern Time Zone).
• Occasional evening or weekend work may be required depending on project deadlines and trial needs.

Knowledge, Skills, and Abilities:

• Advanced understanding of clinical trial management, from initiation to close-out.
• Ability to analyze clinical trial data and provide insights to improve study outcomes.
• Familiarity with EDC (Electronic Data Capture) systems and IRT (Interactive Response Technology).
• Strong problem-solving and critical-thinking skills.
• Ability to maintain confidentiality and handle sensitive information responsibly.
• Highly motivated, self-driven, and able to work autonomously.
• Exceptional attention to detail and the ability to manage complex information.

Benefits:

• Competitive compensation based on experience.
• Opportunity to work remotely, offering flexibility and a better work-life balance.
• Access to professional development resources and training programs.
• Collaborative and supportive team environment.
• Health and wellness benefits, including medical, dental, and vision (if applicable under the contract terms).
• Paid time off (PTO) and holidays.
• Opportunities for career advancement and growth within a reputable company.

Why Join HR Service Jobs?

• Work Flexibility: Enjoy the convenience and flexibility of working from home, allowing you to create a work-life balance that suits your needs.
• Dynamic Environment: Join a leading company with a diverse and inclusive culture that values innovation, collaboration, and professional growth.
• Impactful Work: Play a key role in advancing clinical research and contributing to the success of critical healthcare studies.
• Career Advancement: Benefit from ample opportunities for career development in the ever-growing field of clinical research.

How to Apply:

If you are passionate about clinical research and meet the qualifications outlined above, we encourage you to apply. Please submit your updated resume, along with a cover letter that highlights your experience in clinical trials, specifically your work in a senior CRA role. Applications can be sent via email to us or through our online portal.