1 243 Bahrain Institute For Scientific Research jobs in Bahrain
Clinical Research Associate
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Key responsibilities include site initiation visits, routine monitoring, and close-out visits. You will build strong relationships with investigators and site staff, providing guidance and support throughout the trial. The role requires meticulous attention to detail, excellent organizational skills, and a deep understanding of Good Clinical Practice (GCP) guidelines. You will be expected to manage multiple study sites simultaneously and ensure that all study-related activities are conducted ethically and scientifically. Your ability to identify and resolve issues promptly will be critical to the study's progress.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 2-3 years of experience as a Clinical Research Associate or in a similar clinical research role.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Strong understanding of clinical trial processes and documentation.
- Excellent communication, interpersonal, and presentation skills.
- Proficiency in using clinical trial management software.
- Ability to travel as required.
Clinical Research Associate
Posted today
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Job Description
Key Responsibilities:
- Conduct site initiation visits, interim monitoring visits, and site closure visits to ensure study protocol adherence and data integrity.
- Verify that study conduct is in compliance with the protocol, FDA regulations, ICH guidelines, and other applicable regulatory requirements.
- Manage and train site staff on study-related procedures and documentation.
- Oversee the informed consent process and ensure patient rights and safety are protected.
- Monitor the accuracy, completeness, and quality of clinical trial data.
- Collect and review essential documents for trial sites.
- Liaise between the study sponsor, investigators, and site staff to ensure effective communication.
- Identify and report any adverse events or protocol deviations promptly.
- Maintain accurate and up-to-date study documentation and records.
- Participate in study team meetings and contribute to problem-solving efforts.
- Ensure all trial-related activities are documented appropriately.
- Contribute to the development of clinical study protocols and other study documents.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A Master's degree is a plus.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical research role.
- In-depth knowledge of Good Clinical Practice (GCP) and regulatory guidelines.
- Experience in monitoring clinical trials across various therapeutic areas.
- Strong understanding of clinical trial processes and documentation requirements.
- Excellent organizational, time management, and problem-solving skills.
- Proficiency in clinical data management systems and Microsoft Office Suite.
- Strong communication and interpersonal skills, with the ability to build rapport with investigators and site staff.
- Detail-oriented with a commitment to accuracy and data quality.
- Ability to travel to clinical trial sites as required.
- Relevant certifications like CRA or CCRA are highly beneficial.
Clinical Research Associate
Posted today
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Job Description
Key Responsibilities:
- Conduct site visits, including pre-study, initiation, interim monitoring, and close-out visits.
- Verify data accuracy and completeness by reviewing source documents and electronic data capture systems.
- Ensure compliance with study protocols, investigator brochures, and GCP guidelines.
- Monitor patient recruitment and retention efforts at investigational sites.
- Train and support site staff on study requirements and regulatory compliance.
- Manage essential study documents and regulatory binders.
- Identify and report adverse events and protocol deviations.
- Facilitate communication between the sponsor and investigational sites.
- Address site-specific issues and implement corrective actions as needed.
- Prepare monitoring visit reports and track action items.
Qualifications:
- Bachelor's degree in a life science, nursing, or a related field. Advanced degree or relevant certifications are a plus.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience with various therapeutic areas and study phases.
- Proficiency in clinical trial management software (CTMS) and electronic data capture (EDC) systems.
- Excellent organizational, communication, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to travel to investigational sites as required.
- Attention to detail and commitment to data integrity.
- Proficiency in English and relevant local languages.
Clinical Research Associate
Posted today
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Job Description
- Identifying and qualifying potential clinical trial sites and investigators.
- Conducting site initiation visits to ensure protocol and regulatory compliance.
- Performing routine monitoring visits to assess patient safety, data accuracy, and adherence to the protocol.
- Ensuring all study-related documentation is maintained accurately and in a timely manner.
- Managing study supplies and investigational product at clinical sites.
- Resolving site-specific issues and providing ongoing support to investigators and site staff.
- Preparing monitoring reports and communicating findings to study teams and management.
- Participating in the development of study protocols and case report forms.
- Ensuring compliance with Good Clinical Practice (GCP) guidelines and applicable regulations.
Clinical Research Associate
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Clinical Research Associate (CRA)
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Key Responsibilities:
- Perform site selection, initiation, interim monitoring, and study closure visits in accordance with GCP and study-specific requirements.
- Monitor study conduct to ensure adherence to the clinical trial protocol, regulatory requirements, and internal SOPs.
- Verify the accuracy and completeness of clinical trial data through source data verification (SDV).
- Ensure proper investigational product accountability and management at study sites.
- Identify, resolve, and escalate site-level issues to the clinical project manager.
- Train and support investigators and study site staff on study procedures, data collection, and regulatory requirements.
- Prepare and present study progress, challenges, and action plans during team meetings.
- Maintain accurate and complete trial documentation, including monitoring visit reports.
- Ensure timely submission of essential documents and study-related materials.
- Contribute to the development of study protocols and monitoring plans.
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 2-3 years of direct experience as a CRA or in a similar clinical trial monitoring role.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Proven experience in performing site monitoring visits and writing monitoring reports.
- Excellent communication, interpersonal, and negotiation skills.
- Strong analytical and problem-solving abilities with exceptional attention to detail.
- Ability to travel to study sites as required (estimated 50-70% travel).
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Self-motivated, organized, and able to manage multiple priorities effectively.
Clinical Research Associate (Pharmaceutical)
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Clinical Research Associate (Oncology)
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- Conducting pre-study, initiation, monitoring, and close-out visits at clinical trial sites.
- Ensuring compliance with the study protocol, regulatory requirements, and company SOPs.
- Verifying the accuracy, completeness, and quality of clinical data through source data verification (SDV).
- Monitoring patient safety and reporting adverse events (AEs) and serious adverse events (SAEs) in a timely manner.
- Training and supporting site staff on study-related procedures and documentation.
- Building and maintaining positive relationships with investigators and site personnel.
- Managing study documentation and ensuring the Investigator Site File (ISF) is maintained accurately.
- Identifying site issues and implementing corrective and preventive actions (CAPAs).
- Coordinating with internal study teams, including project managers and data managers.
- Ensuring timely drug supply and accountability at study sites.
- Participating in Investigator Meetings and relevant training sessions.
- Reporting on site performance and study progress to the clinical project manager.
Clinical Research Associate (Pharmaceutical)
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Clinical Research Associate (Pharmaceutical)
Posted today
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