Position Title: Clinical Research Associate (CRA)
Location: France
Reports To: Clinical Team Manager
Work Model: Remote/Hybrid
Work Type: Full-time

A Clinical Research Associate (CRA) plays a crucial role in the planning, execution, and management of clinical trials. CRAs ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and study protocols. This role involves working closely with site staff, monitoring trial progress, and ensuring data integrity.

Key Responsibilities:

• Study Preparation and Planning:
  • Assist in the design, development, and writing of clinical trial protocols, case report forms (CRFs), and informed consent forms (ICFs).
  • Ensure all necessary approvals are obtained, including ethics committee and regulatory submissions.
• Site Management:
  • Conduct site selection, initiation, monitoring, and close-out visits.
  • Train site staff on study protocols, procedures, and GCP compliance.
  • Monitor and report on site performance, including recruitment, data collection, and adherence to the protocol.
• Data Management and Analysis:
  • Ensure accurate and timely collection, review, and entry of data.
  • Perform source data verification to ensure data integrity and compliance.
  • Assist in resolving data queries and discrepancies.
• Regulatory Compliance:
  • Ensure all activities are conducted in accordance with GCP, ICH guidelines, and regulatory requirements.
  • Maintain thorough documentation of study activities and correspondence.
  • Assist in preparation for and participate in regulatory inspections and audits.
• Communication and Reporting:
  • Serve as the primary point of contact between the sponsor, sites, and regulatory authorities.
  • Provide regular updates on study progress to the project manager and other stakeholders.
  • Prepare and present study findings and reports as required.

Qualifications:

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
• Minimum of 2 years of experience as a CRA or in a related clinical research role.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong organizational and time-management skills.
• Excellent communication and interpersonal skills.
• Ability to travel as required.

Preferred Skills:

• Advanced degree (e.g., Master’s, Ph.D.) in a relevant field.
• Experience with electronic data capture (EDC) systems.
• Proficiency in multiple languages.
• Experience in specific therapeutic areas such as oncology, cardiology, or neurology.

Benefits:

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Work on cutting-edge clinical trials with leading industry sponsors.

Reports To: Clinical Team Manager
Work Model: Office-based
Work Type: Full-Times)
Location: South Korea

Job Summary:
The Clinical Research Associate (CRA) will oversee and monitor clinical trials, ensuring they are conducted in accordance with study protocols, Good Clinical Practice (GCP), and local regulatory requirements. The CRA will establish effective communication with trial sites and verify data accuracy to support high-quality research and patient safety.

Key Responsibilities:

1. Site Management and Monitoring:
   • Conduct site initiation, routine monitoring, and close-out visits as per study requirements.
   • Train site personnel on study protocols and ensure compliance with GCP, regulatory, and ethical guidelines.
   • Confirm that clinical trial sites have adequate supplies, resources, and trained staff to conduct studies.
2. Data Verification and Quality Control:
   • Review source data and case report forms (CRFs) for accuracy, completeness, and adherence to protocol.
   • Identify and resolve discrepancies, maintaining high standards for data quality and integrity.
   • Conduct quality control checks to ensure data aligns with regulatory requirements.
3. Regulatory Compliance:
   • Ensure that all trial activities are conducted in compliance with Serbian regulatory guidelines and international standards.
   • Maintain organized documentation of all monitoring activities.
   • Assist in preparation for regulatory inspections or audits and support follow-up actions.
4. Communication and Reporting:
   • Establish and maintain regular communication with site personnel, clinical project managers, and cross-functional teams.
   • Prepare and submit monitoring visit reports, detailing observations, action items, and recommendations.
   • Address site performance issues and escalate to project managers when necessary.
5. Patient Safety and Adverse Event Reporting:
   • Monitor patient safety throughout the trial process, including review and reporting of adverse events (AEs) and serious adverse events (SAEs) in accordance with protocol and regulatory standards.
6. Continuous Improvement:
   • Stay informed about developments in clinical research practices, regulatory requirements, and industry trends specific to the Serbian market.
   • Participate in training sessions to stay updated on best practices and identify opportunities for process improvements.

Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum 2 years of experience as a CRA, with experience in Serbian clinical trials preferred.
• Strong understanding of Serbian clinical research regulations, GCP, and industry standards.
• Effective communication and relationship-building skills.
• Detail-oriented with strong organisational and time-management skills.
• Ability to work independently and adapt to local and international team dynamics.

Benefits:

• Competitive salary and benefits package tailored to the Serbian market.
• Professional development opportunities and access to global industry resources.
• Opportunity to work on innovative clinical trials with leading pharmaceutical and biotech sponsors.

Work Type: Full-time
Work Model: Remote
Location: Worldwide (Remote/Multiple Locations)

The SAS Programmer is responsible for providing statistical programming support for clinical trials and other pharmaceutical research projects. This role involves creating, testing, and maintaining SAS programs to analyze clinical trial data and generate reports.

Key Responsibilities:

• Statistical Programming:
  • Develop and validate SAS programs to produce datasets, tables, listings, and figures (TLFs) for clinical trial reports
  • Write and maintain complex SAS code to analyze clinical data according to project specifications and regulatory requirements.
• Data Management:
  • Collaborate with data management teams to ensure accurate and efficient data collection, cleaning, and processing.
  • Create and maintain documentation for datasets, including data definitions and specifications.
• Quality Control:
  • Perform quality control checks to ensure the accuracy and integrity of all programming deliverables.
  • Review and validate code written by other programmers to ensure compliance with regulatory standards and internal guidelines.
• Project Collaboration:
  • Work closely with biostatisticians, clinical data managers, and other team members to meet project timelines and objectives.
  • Participate in project meetings and provide updates on programming activities and progress.
• Regulatory Compliance:
  • Ensure all programming activities comply with industry standards, regulatory requirements, and company SOPs.
  • Prepare documentation and support regulatory submissions as needed.
• Continuous Improvement:
  • Stay current with advancements in SAS programming and clinical trial methodologies.
  • Identify and implement process improvements to enhance efficiency and quality.

Qualifications:

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.
• Proficiency in SAS programming, including BASE SAS, SAS/STAT, and SAS Macro language.
• Strong understanding of clinical trial data and regulatory requirements (e.g., CDISC, SDTM, ADaM).
• Excellent analytical and problem-solving skills.
• Effective communication and collaboration skills, with the ability to work in a global team environment.
• Experience in the pharmaceutical or biotechnology industry is highly desirable

Benefits:

• Competitive salary and benefits package
• Opportunities for professional growth and development.
• Work on cutting-edge clinical trials with leading industry sponsors.

Work Environment:

• Remote or preferably in Europe or India requiring flexibility to work with international teams across different time zones.
• Collaborative work with interdisciplinary teams, including biostatisticians, clinical data managers, and regulatory professionals.

Work Type: Full-time
Work Model: Remote
Location: Worldwide (Europe preferred)

A Medical Writer is responsible for creating well-structured, clear, and scientifically accurate documents for various purposes within the clinical research and pharmaceutical industries. This role involves synthesizing complex clinical and scientific data into comprehensive and accessible reports, publications, and regulatory documents.

Key Responsibilities:

• Document Preparation:
  • Write, edit, and review clinical study reports, protocols, investigator brochures, informed consent forms, and regulatory submissions.
  • Develop scientific manuscripts, abstracts, posters, and presentations for publication and conferences.
  • Create patient education materials and other communication tools as needed.
• Research and Analysis:
  • Conduct literature reviews and analyze clinical data to support document preparation.
  • Stay updated with the latest research and developments in relevant therapeutic areas.
  • Ensure accuracy and consistency of scientific content across all documents.
• Regulatory Compliance:
  • Ensure all documents comply with regulatory guidelines, including ICH, GCP, and relevant regional regulations.
  • Assist in the preparation of documents for regulatory submissions, including INDs, NDAs, and BLAs.
• Collaboration and Communication:
  • Work closely with clinical teams, statisticians, regulatory affairs, and other stakeholders to gather and incorporate feedback.
  • Serve as a liaison between different departments to ensure timely and efficient document completion.
  • Provide clear and effective communication of scientific data and concepts.
• Quality Control:
  • Maintain high standards of quality, ensuring all documents are free from errors and inconsistencies.
  • Conduct thorough reviews and revisions of documents to ensure clarity, accuracy, and adherence to style guidelines.

Qualifications:

• Bachelor’s degree in life sciences, pharmacy, medical writing, or a related field.
• Minimum of 2 years of experience in medical writing or a related role.
• Excellent written and verbal communication skills.
• Strong understanding of scientific and medical terminology.
• Proficiency in Microsoft Office and other relevant software.

Preferred Skills:

• Advanced degree (e.g., Master’s, Ph.D.) in a relevant field.
• Experience with regulatory writing and submissions.
• Knowledge of electronic document management systems (EDMS).
• Familiarity with specific therapeutic areas such as oncology, cardiology, or neurology.

Benefits:

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Work on diverse and challenging projects with leading industry sponsors.

Work Type: Full-time
Work Model: Office Based
Location: South Africa

A Clinical Team Manager (CTM) oversees the operational aspects of clinical trials, ensuring that projects are completed on time, within budget, and in compliance with regulatory requirements and company standards. The CTM is responsible for leading and managing the clinical research team, coordinating with various stakeholders, and ensuring the quality and integrity of clinical trial data.

Key Responsibilities:

• Project Management:
  • Plan, implement, and manage clinical trials from initiation to close-out.
  • Develop and maintain study timelines, budgets, and resource allocation.
  • Ensure compliance with study protocols, GCP, ICH guidelines, and regulatory requirements.
• Team Leadership:
  • Lead, mentor, and manage a team of CRAs and other clinical research staff.
  • Conduct regular team meetings to review progress, address issues, and ensure alignment with study objectives.
  • Provide training and development opportunities for team members.
• Site and Vendor Management:
  • Oversee site selection, initiation, monitoring, and close-out activities.
  • Manage relationships with clinical trial sites, investigators, and vendors.
  • Ensure timely and effective communication with all stakeholders.
• Quality Control and Data Integrity:
  • Ensure high-quality data collection and documentation throughout the study.
  • Conduct regular quality checks and audits to ensure adherence to protocols and regulatory requirements.
  • Address and resolve any issues or discrepancies in data collection and reporting.
• Regulatory and Compliance:
  • Ensure all study activities comply with relevant regulations, guidelines, and standards.
  • Prepare for and participate in regulatory inspections and audits.
  • Maintain comprehensive and accurate documentation of study activities.
• Communication and Reporting:
  • Serve as the primary point of contact for project sponsors and stakeholders.
  • Provide regular updates on study progress, including milestones and deliverables.
  • Prepare and present study reports and findings as required.

Qualifications:

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
• Minimum of 5 years of experience in clinical research, with at least 2 years in a supervisory or management role.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong organizational, leadership, and time-management skills.
• Excellent communication and interpersonal skills.
• Ability to travel as required.

Preferred Skills:

• Advanced degree (e.g., Master’s, Ph.D.) in a relevant field.
• Experience in managing large, multi-center clinical trials.
• Proficiency in multiple languages.
• Experience in specific therapeutic areas such as oncology, cardiology, or neurology.

Benefits:

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Work on innovative clinical trials with leading industry sponsors.

Work Type: Full-time
Work Model: Office Based
Location: South Africa

The Clinical Research Associate (CRA) will oversee and monitor clinical trials in India, ensuring they are conducted in accordance with study protocols, Good Clinical Practice (GCP), and local regulatory requirements. The CRA will establish effective communication with trial sites and verify data accuracy to support high-quality research and patient safety.

Key Responsibilities:

• Site Management and Monitoring:
  • Conduct site initiation, routine monitoring, and close-out visits as per study requirements.
  • Train site personnel on study protocols and ensure compliance with GCP, regulatory, and ethical guidelines.
  • Confirm that clinical trial sites have adequate supplies, resources, and trained staff to conduct studies.
• Data Verification and Quality Control:
  • Review source data and case report forms (CRFs) for accuracy, completeness, and adherence to protocol.
  • Identify and resolve discrepancies, maintaining high standards for data quality and integrity.
  • Conduct quality control checks to ensure data aligns with regulatory requirements.
• Regulatory Compliance:
  • Ensure that all trial activities are conducted in compliance with relevant regulatory guidelines and international standards.
  • Maintain organized documentation of all monitoring activities.
  • Assist in preparation for regulatory inspections or audits and support follow-up actions.
• Communication and Reporting:
  • Establish and maintain regular communication with site personnel, clinical project managers, and cross-functional teams.
  • Prepare and submit monitoring visit reports, detailing observations, action items, and recommendations.
  • Address site performance issues and escalate to project managers when necessary.
• Patient Safety and Adverse Event Reporting:
  • Monitor patient safety throughout the trial process, including review and reporting of adverse events (AEs) and serious adverse events (SAEs) in accordance with protocol and regulatory standards.
• Continuous Improvement:
  • Stay informed about developments in clinical research practices, regulatory requirements, and industry trends.
  • Participate in training sessions to stay updated on best practices and identify opportunities for process improvements.

Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 2 years of experience as a CRA, with experience in relevant clinical trials preferred.
• Strong understanding of Indian clinical research regulations, GCP, and industry standards.
• Effective communication and relationship-building skills.
• Detail-oriented with strong organizational and time-management skills.
• Ability to work independently and adapt to local and international team dynamics.

Benefits:

• Competitive salary and benefits package tailored to the Indian market.
• Professional development opportunities and access to global industry resources.
• Opportunity to work on innovative clinical trials with leading pharmaceutical and biotech sponsors.