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Associate Clinical Research Associate
3 miesięcy temu
Job Description
- Join a multi-award-winning leading biopharmaceutical company
- Be part of growing team of Clinical Research Associates
- Use new technology and smart monitoring tools
- Have flexibility of work and good work-life balance
Apply today
On this position you will be accountable for performance and compliance for assigned protocols and sites in a country. You will act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites and actively develop and expand the territory for clinical research, finding and developing new sites.
Your key responsibilities:
- Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits) and record clear, comprehensive and accurate visit & non-visit contact reports.
- Ensure by monitoring activities that:
- Data generated at site are complete, accurate and unbiased.
- Subjects' right, safety and well-being are protected.
- Perform clinical study site management/monitoring activities in compliance with local regulations, ICH-GCP, Sponsor SOPs, protocol, Site Monitoring Plan and associated documents.
- Coordinate and manage various tasks in collaboration with other sponsor roles.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identify and assess site performance, quality or compliance problems in collaboration with CRA Manager, Project Manager, Therapeutical Area Head and Country Director as needed.
- Manage and maintain clinical trial systems such as CTMS, eTMF, etc.
- Share the knowledge and best practices, nurture a learning culture to boost efficiency and competence of our team.
- Follow the country strategy defined by Country Director.
You should apply if you have:
- Min. 1 year of experience in clinical trials.
- Proven skills in site management, including management of site performance and patient recruitment.
- Good IT skills, ability to learn and operate new IT applications.
- Ability to understand and analyse data/metrics.
- Capable of managing complex issues, works in a solution-oriented manner.
- Fluent in English (verbal and written) and local language, excellent communication and presentation skills.
- Good understanding and working knowledge of clinical research, local regulations, ICH-GCP.
- M.A/ M.Sc degree with strong emphasis in medical/bioscience background.
- Ability to travel domestically and internationally approximately 50% of working time. Expected travelling 2-3 days/week.
- Valid driving license.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
RemoteShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
08/30/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:08/30/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R309082
