Fresher Jobs
Job Summary
Fresher Jobs is seeking a dedicated and experienced Senior Clinical Research Associate (CRA) to join our dynamic team. In this fully remote role, you will play a critical part in overseeing clinical trials, ensuring compliance with regulatory requirements, and maintaining the highest quality standards in clinical research. As a Senior CRA, you will be responsible for managing study sites, coordinating with stakeholders, and contributing to the successful delivery of clinical projects.
Key Responsibilities
- Oversee the planning, execution, and monitoring of clinical trials in accordance with regulatory guidelines and company protocols.
- Conduct site selection, initiation, monitoring, and closeout visits to ensure data integrity and compliance.
- Collaborate with cross-functional teams, including project managers, data managers, and regulatory affairs, to ensure timely and accurate reporting of clinical trial data.
- Provide training and support to site personnel on study protocols, procedures, and compliance requirements.
- Review and approve clinical study documentation, including protocols, informed consent forms, and monitoring reports.
- Ensure timely resolution of site issues and provide ongoing support to sites to enhance performance and compliance.
- Maintain accurate and up-to-date study files and documentation in accordance with Good Clinical Practice (GCP) and company policies.
- Stay informed about industry trends, regulations, and best practices in clinical research.
Required Skills and Qualifications
- Bachelors degree in Life Sciences, Nursing, Pharmacy, or a related field; Masters degree preferred.
- Proven experience as a Clinical Research Associate, with a minimum of 5 years in clinical research, preferably in a senior or lead role.
- Strong knowledge of GCP, FDA regulations, and ICH guidelines.
- Excellent communication, organizational, and problem-solving skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Proficient in using clinical trial management systems (CTMS) and other relevant software.
Experience
- Minimum of 5 years of experience in clinical research, with demonstrated expertise in monitoring clinical trials from initiation through closeout.
- Experience in multiple therapeutic areas is a plus.
- Previous experience working with remote teams and managing sites across various geographical locations.
Working Hours
- Flexible working hours with the ability to manage your schedule while meeting project deadlines and requirements.
- This is a full-time remote position, requiring occasional availability for meetings during standard business hours.
Knowledge, Skills, and Abilities
- Strong analytical skills and attention to detail.
- Ability to manage multiple projects and prioritize tasks effectively.
- Knowledge of data management and statistical analysis is advantageous.
- Strong interpersonal skills to foster relationships with study sites and team members.
Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Flexible work schedule and remote work options.
- Professional development opportunities, including training and certifications.
- Generous paid time off and holidays.
Why Join
At Fresher Jobs, we are committed to fostering a collaborative and innovative work environment. As a leader in the clinical research industry, we value our employees and provide them with the resources and support needed to excel in their roles. Join our team and be part of meaningful projects that impact patient lives and advance medical research.
How to Apply
If you are a qualified candidate with a passion for clinical research and a desire to work in a flexible, remote setting, we want to hear from you! Please submit your resume and a cover letter detailing your relevant experience and why you would be a great fit for our team to us. Applications will be accepted until the position is filled.