1 074 Bahrain Institute For Scientific Research jobs in Bahrain
Clinical Research Associate
Posted 2 days ago
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Key responsibilities include initiating, monitoring, and closing out clinical trial sites. This involves conducting site visits, reviewing essential documents, ensuring proper drug accountability, and verifying source data against case report forms. The CRA will serve as the primary liaison between the study sponsor and the clinical sites, facilitating communication and resolving any issues that arise. Ensuring compliance with safety reporting requirements and timely reporting of adverse events is paramount. The successful candidate will play a vital role in maintaining the integrity and quality of clinical trial data, which is essential for regulatory submissions.
The ideal candidate will possess a Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field. A minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical research role is required. Thorough knowledge of GCP, FDA regulations, and clinical trial methodologies is essential. Excellent organizational, communication, and interpersonal skills are necessary for effective site management and sponsor interaction. The ability to travel to trial sites periodically is required. Proficiency in clinical trial management software and electronic data capture (EDC) systems is highly desirable. This is an excellent opportunity for a motivated professional to advance their career in pharmaceutical research and development.
Clinical Research Associate
Posted 2 days ago
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Job Description
Clinical Research Associate
Posted 2 days ago
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Job Description
Key Responsibilities:
- Conduct site initiation, monitoring, and close-out visits for clinical trial sites.
- Verify the accuracy, completeness, and integrity of clinical trial data through source data verification.
- Ensure compliance with Good Clinical Practice (GCP) guidelines, FDA regulations, and protocol requirements.
- Train and support site staff on study protocols, procedures, and regulatory requirements.
- Manage communication between study sites, the sponsor, and other stakeholders.
- Monitor patient safety and report adverse events as per protocol.
- Review and approve site essential documents and investigational product accountability.
- Identify potential risks and issues at clinical sites and develop mitigation strategies.
- Prepare and present monitoring visit reports to the clinical trial team.
- Assist in the selection and qualification of clinical trial sites.
- Contribute to the development of clinical trial protocols and case report forms (CRFs).
- Ensure timely data entry and query resolution.
- Maintain detailed and accurate records of all monitoring activities.
- Participate in Investigator Meetings and internal team meetings.
- Stay abreast of advancements in clinical research methodologies and regulatory affairs.
- Bachelor's degree in a life science, nursing, or related healthcare field.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven experience in monitoring clinical trial sites and conducting source data verification.
- Excellent understanding of clinical trial processes and documentation.
- Strong analytical, problem-solving, and organizational skills.
- Exceptional communication, interpersonal, and negotiation skills.
- Ability to travel to clinical sites as required (up to 50%).
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Detail-oriented with a commitment to accuracy and quality.
- Ability to work independently and manage multiple projects effectively.
- Relevant certifications (e.g., ACRP, SoCRA) are a plus.
Lead Clinical Research Associate
Posted today
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Clinical Research Associate (Pharmaceutical)
Posted today
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Senior Clinical Research Associate
Posted today
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Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field; advanced degree preferred.
- Minimum of 5 years of progressive experience as a Clinical Research Associate in the pharmaceutical industry.
- In-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant regulatory requirements.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Strong understanding of clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent interpersonal, communication, and presentation skills.
- Ability to travel to clinical sites as required (estimated 50% travel).
- Demonstrated ability to work independently and as part of a team.
- High level of accuracy and attention to detail.
Clinical Research Associate (CRA)
Posted today
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Key Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits in accordance with study protocols and regulatory requirements.
- Ensure the quality and integrity of clinical trial data collected at study sites.
- Verify that the rights and well-being of human subjects are protected throughout the trial.
- Monitor study conduct to ensure compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
- Train and support site staff on study procedures, data collection, and regulatory requirements.
- Oversee drug accountability and ensure proper investigational product handling.
- Resolve data discrepancies and ensure timely query resolution.
- Prepare monitoring visit reports and communicate findings to study teams and management.
- Manage relationships with principal investigators and site personnel.
- Contribute to the development of study-related documents, such as protocols and case report forms (CRFs).
- Identify and report adverse events and safety concerns to the sponsor and regulatory authorities as required.
- Ensure all site regulatory documents are accurate and complete.
- Manage multiple clinical trials and sites simultaneously.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate, monitoring clinical trials.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical research.
- Proven experience in conducting site visits and managing clinical trial sites.
- Excellent understanding of clinical trial processes from start-up to close-out.
- Strong organizational, analytical, and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to effectively communicate with diverse stakeholders.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and manage time effectively in a remote setting.
- Willingness to travel as needed (typically up to 50-60%).
- Strong attention to detail and commitment to data accuracy.
This is a unique remote opportunity for a qualified CRA to join a dynamic and innovative pharmaceutical company. If you are passionate about advancing medical science and meet the qualifications, we encourage you to apply.
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Remote Clinical Research Associate
Posted today
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- Conducting remote monitoring of clinical trial sites to ensure compliance with protocols and regulations.
- Verifying the accuracy, completeness, and consistency of clinical trial data.
- Ensuring the safety of study participants and the integrity of the trial.
- Reviewing essential study documents and Case Report Forms (CRFs).
- Communicating effectively with investigators, study coordinators, and internal project teams.
- Identifying and escalating potential issues or deviations from the protocol.
- Contributing to the development and execution of clinical trial protocols.
- Maintaining comprehensive and accurate documentation of all monitoring activities.
- Providing training and support to site personnel as needed.
Clinical Research Associate (Remote)
Posted today
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Key Responsibilities:
- Conduct site visits (remote and/or on-site as needed) to assess protocol adherence and data integrity.
- Ensure compliance with GCP, regulatory requirements, and study protocols.
- Verify source documentation and patient records.
- Train site staff on study procedures and regulatory requirements.
- Manage communication between study sites and the sponsor.
- Resolve site-level issues and escalate as necessary.
- Monitor study timelines and budgets at the site level.
- Prepare and submit monitoring visit reports.
- Ensure timely data entry and query resolution.
- Support site audit and inspection readiness.
Senior Clinical Research Associate
Posted today
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