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Title
Text copied to clipboard!Clinical Research Associate
Description
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We are looking for a dedicated Clinical Research Associate (CRA) to join our dynamic research team. The Clinical Research Associate will play a crucial role in the successful execution of clinical trials, ensuring compliance with regulatory requirements, protocol adherence, and data integrity. The ideal candidate will have a strong background in clinical research, excellent organizational skills, and the ability to effectively communicate with various stakeholders, including investigators, sponsors, and regulatory authorities.
As a Clinical Research Associate, you will be responsible for monitoring clinical trials at various investigative sites, ensuring that the trials are conducted according to the approved protocol, Good Clinical Practice (GCP), and applicable regulatory requirements. You will perform site initiation visits, routine monitoring visits, and close-out visits, documenting findings and ensuring corrective actions are implemented when necessary. You will also be responsible for verifying the accuracy and completeness of clinical data, reviewing source documents, and ensuring that informed consent procedures are properly followed.
In addition, you will collaborate closely with clinical investigators and site staff to provide training and guidance on protocol requirements, regulatory compliance, and data collection procedures. You will serve as the primary point of contact between the investigative sites and the sponsor, facilitating effective communication and timely resolution of issues. You will also assist in the preparation and submission of regulatory documents, including ethics committee submissions, amendments, and safety reports.
The Clinical Research Associate will be expected to maintain comprehensive and accurate records of monitoring activities, site communications, and trial documentation. You will participate in regular team meetings, providing updates on trial progress, site performance, and any issues or concerns identified during monitoring visits. You will also contribute to the development and implementation of monitoring plans, standard operating procedures (SOPs), and quality assurance processes to ensure the highest standards of clinical research conduct.
To succeed in this role, you must possess strong analytical and problem-solving skills, attention to detail, and the ability to manage multiple tasks and priorities effectively. You should have excellent interpersonal and communication skills, with the ability to build and maintain positive relationships with site personnel, sponsors, and regulatory authorities. You must also demonstrate a thorough understanding of clinical trial processes, regulatory requirements, and ethical considerations in clinical research.
This position offers an exciting opportunity to contribute to groundbreaking clinical research projects, working alongside experienced professionals in a collaborative and supportive environment. You will have the chance to expand your knowledge and skills in clinical research, regulatory compliance, and project management, while making a meaningful impact on the advancement of medical science and patient care.
If you are passionate about clinical research, committed to excellence, and eager to take on new challenges, we encourage you to apply for this rewarding position as a Clinical Research Associate.
Responsibilities
Text copied to clipboard!- Conduct site initiation, monitoring, and close-out visits to ensure compliance with protocols and regulations.
- Verify accuracy and completeness of clinical data and source documentation.
- Ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Provide training and guidance to site personnel on protocol requirements and data collection procedures.
- Maintain accurate records of monitoring activities, site communications, and trial documentation.
- Assist in preparation and submission of regulatory documents and ethics committee submissions.
- Serve as primary liaison between investigative sites and sponsors, facilitating effective communication.
- Participate in the development and implementation of monitoring plans and quality assurance processes.
Requirements
Text copied to clipboard!- Bachelor's degree in life sciences, nursing, pharmacy, or related field.
- Minimum of 2 years of experience as a Clinical Research Associate or similar role.
- Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Excellent organizational, analytical, and problem-solving skills.
- Ability to manage multiple tasks and priorities effectively.
- Strong interpersonal and communication skills.
- Proficiency in Microsoft Office applications and clinical trial management systems.
- Willingness to travel frequently to investigative sites.
Potential interview questions
Text copied to clipboard!- Can you describe your experience conducting site monitoring visits?
- How do you ensure compliance with regulatory requirements and GCP guidelines during clinical trials?
- What strategies do you use to effectively manage multiple clinical trial sites simultaneously?
- Can you provide an example of a challenging situation you encountered during a clinical trial and how you resolved it?
- How do you maintain effective communication with site personnel, sponsors, and regulatory authorities?
