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United-Biosource-CorporationSr Clinical Research Associate
United-Biosource-Corporation is hiring a remote Sr Clinical Research Associate to support clinical trials and observational studies throughout the drug development and commercialization lifecycle. The organization focuses…
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About This Role
United-Biosource-Corporation is hiring a remote Sr Clinical Research Associate to support clinical trials and observational studies throughout the drug development and commercialization lifecycle. The organization focuses on advancing healthcare and improving patient outcomes through clinical trial support and real-world evidence generation. Operating under core values that include being collaborative, conscientious, curious, consultative, and compassionate, the company maintains an inclusive workplace designed to foster creativity. This role suits professionals with a…
Job Description
United-Biosource-Corporation is hiring a remote Sr Clinical Research Associate to support clinical trials and observational studies throughout the drug development and commercialization lifecycle. The organization focuses on advancing healthcare and improving patient outcomes through clinical trial support and real-world evidence generation. Operating under core values that include being collaborative, conscientious, curious, consultative, and compassionate, the company maintains an inclusive workplace designed to foster creativity.
This role suits professionals with a background in clinical research who have experience in study start-up duties, such as regulatory tasks and contract negotiations. The position requires managing site activities, maintaining data integrity, and ensuring compliance with protocols, regulations, and sponsor guidelines. Responsibilities encompass tasks both remotely and on-site, alongside handling European regional monitoring duties including ethics committee submissions, contract negotiations, and local language translations where applicable. Candidates should be comfortable with a travel commitment of up to 50 percent within the European region.
Responsibilities
- Perform remote and on-site monitoring aligned with project timelines
- Complete travel arrangements and submit expense reports following company policies
- Attend project, department, and one-on-one manager meetings
- Draft site monitoring reports and letters requiring minimal corrections
- Ensure timely follow-up on site action items and issues
- Log site visits, reports, follow-up letters, and contacts into the Clinical Trial Management System
- Oversee Electronic Data Capture data entry and help resolve electronic Case Report Forms
- Review Investigator Site Files and handle Investigational Product reconciliation
- Maintain regular communication with designated study sites
- Fulfill standard operating procedure reviews, training assessments, and documentation on schedule
- Handle European regional monitoring duties including Patient Information Sheet and Informed Consent updates, regulatory submissions via CTIS, and local translations
- Conduct site contract negotiations and review payment details alongside the contract management team
- Maintain the electronic Trial Master File and track essential document collection
- Perform study feasibility assessments with trial sites
Requirements
- Minimum of 24 months of clinical research experience focusing on site management and remote monitoring
- Experience in study start-up including regulatory tasks, contract negotiations, and ethics submissions
- Familiarity with medical terminology and regulatory guidelines
- Proficiency with CTMS, eTMF, EDC, and Microsoft Office applications
- Availability to travel up to 50 percent in the European region
Qualifications
- Bachelor degree, preferably in a Life Science discipline or equivalent professional experience
- At least 6 months of on-site monitoring experience
- Bilingual communication skills in English and the local language where applicable
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the remote work policy for this position?
The position is remote, though it requires up to 50 percent travel within the European region.
What level of experience is required for this role?
Applicants must have a minimum of 24 months of clinical research experience focusing on site management and remote monitoring, along with start-up experience including regulatory work, contract negotiations, and ethics submissions.
What is the employment type?
The posting indicates that this is a full-time position.
What salary is offered for this role?
The salary is not specified in the job posting.
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