3 Remote Senior Clinical Research Associate Cra jobs in whatjobs

Remote Senior Clinical Research Associate (CRA)

60100 Embu, Eastern KES250000 Annually WhatJobs

Posted 19 days ago

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Job Description

full-time
Our client, a leading pharmaceutical research organization, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their fully remote global clinical operations team. In this critical role, you will be responsible for monitoring clinical trials to ensure adherence to protocols, regulatory requirements, and data integrity. The ideal candidate will possess extensive experience in site management, patient safety, and regulatory compliance within the pharmaceutical industry. You will work independently, managing multiple sites remotely, and ensuring the successful execution of clinical studies.

Key Responsibilities:
  • Conduct remote and on-site (as needed, but primarily remote oversight) monitoring visits to assess study conduct and data quality.
  • Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements.
  • Verify the accuracy and completeness of clinical trial data, source documents, and patient records.
  • Manage relationships with clinical investigators and site staff, providing training and support.
  • Oversee study start-up activities, including site selection, initiation, and regulatory documentation.
  • Track study progress, identify risks and issues, and implement corrective and preventative actions (CAPAs).
  • Prepare monitoring reports, study updates, and other essential documentation.
  • Contribute to the development and refinement of clinical trial protocols and associated documents.
  • Ensure timely resolution of data discrepancies and queries.
  • Maintain accurate and up-to-date trial master file (TMF) documentation.

Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree is a plus.
  • Minimum of 5 years of experience as a Clinical Research Associate, with a strong emphasis on remote monitoring and site management.
  • In-depth knowledge of GCP, ICH guidelines, FDA regulations, and other relevant regulatory requirements.
  • Proven ability to manage multiple clinical trials and sites simultaneously from a remote capacity.
  • Excellent understanding of clinical trial processes, drug development, and medical terminology.
  • Strong skills in data analysis, critical thinking, and problem-solving.
  • Exceptional communication, interpersonal, and organizational skills.
  • Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
  • Ability to work autonomously, manage time effectively, and meet strict deadlines in a remote setting.
  • Willingness to travel for occasional essential on-site visits, as required.

This is an outstanding opportunity to contribute to groundbreaking pharmaceutical research while enjoying the flexibility of a fully remote role. Our client offers a competitive salary, comprehensive benefits, and a supportive environment for professional growth within a global organization committed to remote work excellence.
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Remote Senior Clinical Research Associate (CRA)

00100 Makongeni KES360000 Annually WhatJobs

Posted 15 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a dedicated and experienced Remote Senior Clinical Research Associate (CRA) to support the execution of clinical trials. This is a fully remote position, offering the flexibility to manage your workload and contribute to life-changing research from anywhere. You will be responsible for monitoring clinical trial sites, ensuring adherence to protocols, regulations (GCP, ICH), and company SOPs. This role requires a thorough understanding of clinical trial processes, data integrity, and patient safety. Your duties will include conducting site initiation visits, routine monitoring visits, and site closure visits, as well as resolving data discrepancies and ensuring accurate source documentation. The ideal candidate will have a proven track record in clinical research, with at least 5 years of experience as a CRA, preferably with some remote monitoring experience. Exceptional communication, organizational, and problem-solving skills are essential. You will act as the primary point of contact between the investigative sites and the sponsor, fostering strong working relationships. This position requires meticulous attention to detail and the ability to work independently and manage your time effectively. You will also be responsible for identifying and reporting potential site issues and implementing corrective and preventative actions. This is an excellent opportunity for a seasoned CRA to advance their career in a remote-first environment within the pharmaceutical industry. The role is conceptually connected to **Thika, Kiambu, KE**, but is performed entirely remotely.

Key Responsibilities:
  • Monitor clinical trial sites to ensure compliance with protocols, GCP, and regulatory requirements.
  • Conduct site initiation, routine monitoring, and close-out visits.
  • Verify the accuracy and completeness of source documents and case report forms (CRFs).
  • Resolve data queries and ensure data integrity throughout the trial.
  • Act as the primary liaison between investigative sites and the sponsor.
  • Train site staff on study procedures and regulatory requirements.
  • Identify and report potential site issues, implementing corrective and preventative actions (CAPAs).
  • Ensure timely submission of monitoring reports and other required documentation.
  • Maintain effective communication with investigators, site staff, and internal project teams.
  • Contribute to the development and review of study-related documents.
Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • Minimum of 5 years of experience as a Clinical Research Associate (CRA).
  • In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
  • Experience with various therapeutic areas is a plus.
  • Proven ability to conduct effective site monitoring visits.
  • Excellent communication, interpersonal, and organizational skills.
  • Strong problem-solving abilities and attention to detail.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to work independently and manage travel schedules efficiently (if applicable, though this role is remote).
  • Experience working in a remote monitoring capacity is highly desirable.
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Remote Senior Clinical Research Associate (CRA)

80100 Nairobi, Nairobi KES140000 Annually WhatJobs

Posted today

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking an experienced and highly motivated Senior Clinical Research Associate (CRA) to join their globally distributed, fully remote clinical operations team. This vital role will involve the remote oversight and management of clinical trial sites, ensuring compliance with protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. The ideal candidate will have a strong understanding of drug development processes and extensive experience in monitoring clinical trials. You will work independently, leveraging advanced technology and communication platforms to conduct remote site monitoring, data review, and issue resolution. This position requires meticulous attention to detail, excellent organizational skills, and the ability to build and maintain strong relationships with clinical site staff and internal stakeholders. You will be responsible for ensuring the quality, integrity, and accuracy of clinical trial data, while also ensuring patient safety. This is an exceptional opportunity for a seasoned CRA to contribute to groundbreaking pharmaceutical research from a remote setting, enjoying unparalleled flexibility and autonomy. We are looking for a proactive individual who can effectively manage multiple study sites, identify and mitigate risks, and contribute to the successful completion of clinical trials. Your expertise in therapeutic areas and understanding of regulatory submission processes will be highly valued.

Responsibilities:
  • Conduct remote monitoring of clinical trial sites to ensure adherence to protocol, GCP, and regulatory standards.
  • Verify the accuracy and completeness of clinical trial data through remote review of source documents and case report forms (CRFs).
  • Ensure patient safety and rights are protected throughout the trial duration.
  • Train and support site staff on trial protocols, procedures, and data collection requirements.
  • Identify, document, and resolve site-level issues and discrepancies.
  • Prepare monitoring visit reports and follow-up actions in a timely manner.
  • Collaborate with internal project teams, including project managers, data managers, and medical monitors.
  • Contribute to the development and review of clinical trial protocols and other study documents.
  • Ensure timely site activation and efficient trial conduct.
  • Maintain an in-depth understanding of the assigned therapeutic area and study drug.
Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field; advanced degree preferred.
  • Minimum of 5 years of experience as a Clinical Research Associate, with a strong emphasis on remote monitoring.
  • In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
  • Proven ability to manage multiple clinical trial sites effectively in a remote capacity.
  • Excellent organizational, time management, and problem-solving skills.
  • Strong verbal and written communication skills, with the ability to build rapport remotely.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Experience in (Specific Therapeutic Area, e.g., Oncology, Cardiology) is highly desirable.
  • Ability to work independently and as part of a dispersed team.
This is a fully remote position based out of Mombasa, Mombasa, KE .
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