24 Clinical Research Associate jobs in whatjobs
Clinical Research Associate
Posted 21 days ago
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Job Description
Key Responsibilities:
- Conduct site visits to assess trial progress, compliance, and patient safety.
- Ensure adherence to study protocols, SOPs, and GCP guidelines.
- Monitor data accuracy and completeness, and resolve data queries.
- Manage study-related documentation and regulatory binders.
- Facilitate communication between the study sponsor, investigators, and site personnel.
- Oversee patient recruitment and retention efforts.
- Identify and report adverse events and deviations from the protocol.
- Prepare site monitoring reports and track action items.
- Participate in study initiation and close-out visits.
- Contribute to the overall success of clinical research projects.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience with various therapeutic areas is a plus.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to travel to research sites as required for monitoring activities.
- Strong organizational skills and ability to manage multiple tasks effectively.
Clinical Research Associate
Posted 21 days ago
Job Viewed
Job Description
Key Responsibilities:
- Monitor assigned clinical trial sites to ensure adherence to study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical data through source data verification and source document review.
- Ensure all investigational product is accounted for and managed according to the protocol.
- Train and support site staff on study-related procedures, protocol requirements, and data collection.
- Build and maintain strong working relationships with investigators, study coordinators, and site personnel.
- Identify, assess, and report any potential safety concerns or adverse events in a timely manner.
- Prepare monitoring visit reports and follow up on action items with site staff.
- Manage site supplies and ensure necessary documentation is complete and up-to-date.
- Contribute to the selection and initiation of new clinical trial sites.
- Ensure timely resolution of data discrepancies and query resolution.
- Communicate effectively with the internal study team, including project managers, medical monitors, and data managers.
- Represent the company professionally during site visits and interactions.
- Ensure compliance with all relevant local and international regulations pertaining to clinical research in regions including Nairobi, Nairobi, KE .
- Stay current with advancements in clinical research methodologies and therapeutic areas.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field. A Master's degree is a plus.
- Minimum of 4-6 years of direct experience as a Clinical Research Associate, with a strong understanding of monitoring clinical trials.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to effectively communicate complex information.
- Ability to travel extensively (up to 60-70%) to assigned clinical trial sites.
- Proficiency in Microsoft Office Suite.
- Must be able to work independently and manage a remote workload effectively.
- Experience in monitoring trials within Nairobi, Nairobi, KE or similar African healthcare settings is advantageous.
Clinical Research Associate
Posted 21 days ago
Job Viewed
Job Description
Key Responsibilities:
- Conduct pre-study, initiation, interim monitoring, and close-out visits for clinical trial sites.
- Ensure compliance with study protocols, Standard Operating Procedures (SOPs), and regulatory requirements (e.g., GCP, FDA).
- Verify the accuracy, completeness, and integrity of clinical trial data through source document verification.
- Manage and resolve site-specific issues and discrepancies in a timely manner.
- Build and maintain strong relationships with principal investigators and site staff.
- Train site personnel on study-specific procedures and regulatory requirements.
- Monitor patient recruitment and retention efforts at trial sites.
- Prepare and submit monitoring visit reports and follow-up on action items.
- Ensure the proper handling, storage, and accountability of investigational products.
- Collaborate with cross-functional teams, including data management, regulatory affairs, and project management.
- Contribute to the development and review of study-related documents.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
- Thorough understanding of GCP, ICH guidelines, and applicable regulatory requirements.
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Excellent written and verbal communication skills.
- Strong organizational and time management abilities, with the capacity to manage multiple priorities.
- Ability to travel to clinical trial sites as required.
- Proficiency in Microsoft Office Suite.
- Detail-oriented with a high degree of accuracy.
- Experience working in a hybrid remote/on-site model is preferred.
Job Description
Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits according to study plan and protocol.
- Verify the accuracy, completeness, and consistency of clinical trial data through source document review.
- Ensure investigator site compliance with study protocols, SOPs, GCP, and regulatory requirements.
- Manage study documentation and ensure proper filing of essential documents.
- Serve as the primary liaison between the sponsor and clinical investigators.
- Identify and resolve site-related issues and deviations.
- Train site staff on study procedures and protocol requirements.
- Oversee drug accountability and study supplies at the site level.
- Prepare and present monitoring visit reports.
- Contribute to the development of study protocols and clinical trial documents.
Job Description
Clinical Research Associate
Posted 21 days ago
Job Viewed
Job Description
Key Responsibilities:
- Monitor clinical trial sites to ensure compliance with protocol, FDA regulations, ICH-GCP guidelines, and other applicable regulatory requirements.
- Verify the accuracy, completeness, and consistency of data entered into the Case Report Forms (CRFs) and electronic data capture systems against source documentation.
- Conduct pre-study, initiation, routine monitoring, and close-out visits to assigned clinical sites.
- Train and support site staff on study protocols, procedures, and regulatory compliance.
- Identify, document, and resolve site-level issues, escalating critical problems to the Clinical Project Manager as needed.
- Ensure all investigational product is managed according to the protocol and accountability logs.
- Review and ensure timely submission of essential regulatory documents.
- Communicate regularly with investigators and site staff to ensure study progress and address any concerns.
- Prepare and submit monitoring reports in a timely and accurate manner.
- Participate in team meetings and contribute to the overall success of the clinical trial program.
- Build and maintain strong working relationships with site personnel and internal stakeholders.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field. A Master's degree is a plus.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
- Solid understanding of ICH-GCP guidelines, FDA regulations, and clinical trial processes.
- Experience in monitoring multiple therapeutic areas is advantageous.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to present information clearly and concisely.
- Proficiency in clinical trial databases, EDC systems, and Microsoft Office Suite.
- Ability to travel to assigned sites as required by the hybrid work model.
- Detail-oriented with a commitment to maintaining data integrity and patient safety.
Job Description
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Clinical Research Associate
Posted 15 days ago
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Job Description
As a Clinical Research Associate, you will play a crucial role in overseeing and managing clinical trial sites to ensure adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. Your responsibilities will include site initiation, monitoring, and close-out visits, as well as subject recruitment, data collection, and source document verification. You will act as the primary liaison between the sponsor, investigative sites, and regulatory authorities, fostering strong working relationships to facilitate smooth trial operations.
Key duties involve ensuring the quality and integrity of data collected at trial sites, verifying accuracy and completeness, and identifying and resolving data discrepancies. You will be responsible for training site staff on study protocols and procedures, monitoring patient safety, and reporting adverse events. Travel to various clinical sites will be a significant component of this role, requiring meticulous planning and execution to ensure comprehensive oversight. Effective communication and problem-solving skills are essential for addressing site-specific challenges.
The ideal candidate will possess a Bachelor's degree in a life science, nursing, pharmacy, or a related field. A minimum of 3-5 years of experience as a Clinical Research Associate is required, with a strong understanding of clinical trial phases, GCP, and regulatory affairs. Excellent monitoring skills, proficiency in electronic data capture (EDC) systems, and a thorough knowledge of study documentation are essential. Strong organizational, time management, and communication skills are paramount for managing multiple sites and complex trials. The ability to work both independently and collaboratively, with a significant portion of the role requiring travel, is critical for success.
Key Responsibilities:
- Conduct site initiation, monitoring, and close-out visits according to protocol and GCP.
- Ensure the quality, integrity, and accuracy of clinical trial data.
- Verify source documents against case report forms (CRFs) and electronic data capture (EDC) systems.
- Train and support site staff on study protocols and regulatory requirements.
- Monitor patient safety and ensure timely reporting of adverse events.
- Act as the primary point of contact for assigned clinical sites.
- Resolve site-specific issues and implement corrective action plans.
- Maintain accurate and organized trial documentation.
- Liaise effectively with investigators, site staff, and regulatory agencies.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- 3-5 years of experience as a Clinical Research Associate (CRA).
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience with EDC systems and clinical trial management software.
- Excellent monitoring, data verification, and problem-solving skills.
- Strong organizational, time-management, and multitasking abilities.
- Proficient in written and verbal communication.
- Ability to travel frequently to assigned clinical sites.
- Self-motivated with the ability to work independently and as part of a remote/hybrid team.
Job Description
Clinical Research Associate
Posted 21 days ago
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