95 Icon Plc jobs in Kenya
Clinical Research Associate
Posted today
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Clinical Research Associate
Posted 2 days ago
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- Monitor clinical trial sites to ensure compliance with study protocols, SOPs, and GCP.
- Verify the accuracy, completeness, and integrity of clinical data.
- Ensure patient safety and timely reporting of adverse events.
- Conduct site initiation, interim monitoring, and close-out visits.
- Train and support investigators and site staff on study-related procedures.
- Maintain accurate and complete trial master files (TMF) and site files.
- Liaise with study sponsors, CROs, and regulatory authorities.
- Resolve data queries and ensure timely data entry.
- Prepare monitoring reports and communicate findings to the study team.
- Ensure compliance with all applicable regulatory requirements and company policies.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 3-5 years of experience as a Clinical Research Associate or similar role.
- In-depth knowledge of ICH-GCP guidelines and clinical trial regulations.
- Experience in site monitoring and data verification.
- Excellent understanding of clinical trial processes from initiation to close-out.
- Strong organizational, time management, and problem-solving skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent written and verbal communication skills.
- Ability to travel to clinical trial sites as required.
- Strong ethical conduct and attention to detail.
Clinical Research Associate
Posted 2 days ago
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Clinical Research Associate
Posted 4 days ago
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Clinical Research Associate
Posted 4 days ago
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Responsibilities:
- Initiate, monitor, and close-out clinical trial sites.
- Ensure compliance with protocols, SOPs, and GCP guidelines.
- Verify the accuracy and completeness of study data.
- Manage and train site personnel on study requirements.
- Oversee drug accountability and investigational product management.
- Conduct site visits (remote and on-site) as per the monitoring plan.
- Resolve data queries and address protocol deviations.
- Communicate effectively with study teams, investigators, and regulatory authorities.
- Prepare and submit monitoring visit reports.
- Ensure timely submission of essential documents.
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.
- Proven experience in clinical trial monitoring and site management.
- Excellent written and verbal communication skills.
- Strong organizational and time management abilities.
- Proficiency in clinical trial management software.
- Ability to travel as required.
- Detail-oriented with strong analytical skills.
Clinical Research Associate
Posted 5 days ago
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Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits.
- Ensure study conduct adheres to protocol, SOPs, and GCP guidelines.
- Verify accuracy and completeness of clinical data and source documents.
- Monitor patient safety and report adverse events.
- Train and support site staff on study procedures.
- Manage essential regulatory documents at study sites.
- Resolve site-level issues and implement corrective actions.
- Communicate effectively with investigators, site staff, and the clinical study team.
- Prepare monitoring reports and follow-up on action items.
Qualifications:
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial role.
- Thorough knowledge of GCP, ICH guidelines, and clinical trial processes.
- Experience with clinical trial monitoring and data verification.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills.
- Ability to travel to investigational sites as required.
- Proficiency in clinical trial management software and data entry systems.
Clinical Research Associate
Posted 5 days ago
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Clinical Research Associate
Posted 5 days ago
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Responsibilities:
- Identify, select, and train clinical investigators and site staff.
- Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements (e.g., GCP, ICH).
- Verify accuracy and completeness of source documents and case report forms (CRFs).
- Manage study documentation and ensure proper record-keeping.
- Conduct site initiation visits, interim monitoring visits, and close-out visits.
- Resolve data discrepancies and ensure data quality.
- Communicate effectively with investigative sites and internal stakeholders.
- Prepare monitoring reports and action items.
- Ensure adherence to safety reporting requirements.
- Assist with regulatory submissions and audits.
- Participate in study team meetings and provide updates on site progress.
- Bachelor's degree in a life science, nursing, pharmacy, or a related field.
- Proven experience as a Clinical Research Associate or similar role in the pharmaceutical industry.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Strong understanding of clinical trial processes and study designs.
- Excellent organizational skills and attention to detail.
- Effective communication, interpersonal, and negotiation skills.
- Ability to travel to clinical trial sites as required.
- Proficiency in data analysis and reporting.
- Certification from ACRP or SoCRA is a plus.
Remote Clinical Research Associate
Posted today
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Your primary responsibilities will include:
- Conducting site selection visits, initiation visits, monitoring visits, and close-out visits for clinical trial sites.
- Ensuring compliance with study protocols, standard operating procedures (SOPs), and regulatory guidelines (e.g., FDA, EMA, ICH GCP).
- Verifying the accuracy, completeness, and validity of clinical data through source data verification (SDV).
- Monitoring patient safety and reporting adverse events promptly.
- Managing and maintaining essential study documents, including Investigator Site Files (ISFs).
- Communicating effectively with investigators, site staff, and study sponsors.
- Identifying, resolving, and escalating site-level issues in a timely manner.
- Training and mentoring site personnel on study procedures and requirements.
- Ensuring the timely recruitment and retention of participants.
- Preparing monitoring reports and conducting follow-up actions.
- Facilitating drug accountability and investigational product management.
- Assisting with the submission of regulatory documents.
- Ensuring data queries are resolved by the sites.
- Maintaining up-to-date knowledge of relevant therapeutic areas and regulatory landscapes.
- Coordinating with internal study teams and external vendors.
We are looking for a candidate with strong knowledge of clinical trial processes and regulatory affairs. Exceptional attention to detail, excellent organizational skills, and the ability to work autonomously are essential. As this is a remote role, strong self-discipline and communication skills are paramount. Your contributions will directly impact the advancement of innovative medical treatments. The administrative hub for this role is in **Garissa, Garissa, KE**, but the work is conducted entirely remotely.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 2-3 years of experience as a Clinical Research Associate or in a similar clinical research role.
- In-depth understanding of ICH-GCP guidelines and regulatory requirements.
- Experience with clinical trial monitoring and data verification.
- Excellent communication, interpersonal, and problem-solving skills.
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Ability to travel to sites as required (though this role is primarily remote, occasional site visits may be needed).
- Strong organizational skills and meticulous attention to detail.
- Ability to work independently and manage workload effectively in a remote setting.
- Proficiency in relevant software applications.
Lead Clinical Research Scientist
Posted today
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