Freelance Sr CRA II, Norway (0,5 FTE)
- Employer
- Syneos Health
- Location
- Home Based, NOR
- Salary
- Competitive
- Start date
- 8 Mar 2021
- Closing date
- 1 Apr 2021
View more
- Discipline
- Clinical Research, Clinical Trials Manager / Administrator
- Hours
- Part Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
Freelance Sr CRA II
0,5 FTE
Norway
The Senior Clinical Research Associate II (SCRA II) will perform monitoring and site management activities for Phase I-IV clinical research projects to ensure they are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements.
Main responsibilities include:
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
0,5 FTE
Norway
The Senior Clinical Research Associate II (SCRA II) will perform monitoring and site management activities for Phase I-IV clinical research projects to ensure they are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements.
Main responsibilities include:
- Performing site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remotely).
- Ensuring regulatory, company/sponsor SOPs, ICH-GCP and protocol compliance.
- Create monitoring visit reports ensuring finalization within contractual obligation .
- Ensuring all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Evaluating site and staff performance and providing recommendations regarding site-specific actions.
- Supporting subject/patient recruitment, retention and awareness strategies
- Communicating issues to the project team and developing action plans.
- Responsible for site preparedness for audits and inspections.
- May provide training, mentorship and sign off visits to more junior level CRAs.
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
- Around 5-6 years of independent monitoring experience
- CNS (Central Nervous System) experience is required
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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