Remote opportunity at
pfm medical, inc.Senior/Clinical Research Associate
Precision for Medicine presents itself as more than a standard contract research organization, combining trial execution with scientific knowledge, laboratory expertise and data science. Its focus…
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About This Role
Precision for Medicine presents itself as more than a standard contract research organization, combining trial execution with scientific knowledge, laboratory expertise and data science. Its focus includes oncology and rare disease. This Senior Clinical Research Associate job is listed as remote and centers on managing investigator sites and performing on-site monitoring for larger or more complex studies. The Senior CRA takes on the most complex assignments and oversees every part…
Job Description
Precision for Medicine presents itself as more than a standard contract research organization, combining trial execution with scientific knowledge, laboratory expertise and data science. Its focus includes oncology and rare disease. This Senior Clinical Research Associate job is listed as remote and centers on managing investigator sites and performing on-site monitoring for larger or more complex studies.
The Senior CRA takes on the most complex assignments and oversees every part of site management with patient safety and data quality as priorities. Start-up work includes investigator feasibility, recruitment, regulatory and ethics filings, and reviewing documents. The CRA performs pre-study qualification, startup, ongoing monitoring and closeout visits per the protocol, local regulations and ICH good clinical practice. Other responsibilities include reviewing electronic case report entries and resolving queries, managing investigational product stock, identifying and processing serious adverse events, and escalating site risks with contingency ideas. The role may also involve mentoring junior monitors, supporting protocol and report reviews, and participating in proposals and client presentations. Travel is 60 to 70 percent.
Minimum requirements include a bachelor's degree or equivalent experience, at least three and a half years of site monitoring work, oncology experience and global clinical trial experience. Applicants also need strong Microsoft Office skills, working knowledge of drug development, sustained attention to detail and fluent English. Clinical research background, organizational skills and the ability to work efficiently from a home office are preferred. No salary is stated.
Responsibilities
- Oversee every aspect of site management with patient safety and data quality as priorities
- Handle start-up tasks including feasibility, investigator recruitment, regulatory and ethics filings
- Carry out pre-study qualification, startup, ongoing monitoring and closeout visits
- Write monitoring reports, trip reports and follow-up letters on time
- Review investigator site files and reconcile them with the trial master file
- Manage investigational product stock, dispensing checks and storage security
- Review EDC entries, resolve queries and process serious adverse events
- Spot site risks, escalate them and resolve them under project oversight
- Attend investigator and sponsor meetings and help prepare training materials
- Mentor junior monitors and help review protocols and clinical study reports
Requirements
- A bachelor's degree, or an equivalent mix of schooling and work history
- At least three and a half years of on-site monitoring
- Oncology experience and global clinical trial experience
- Strong skills in Outlook, Word, Excel and PowerPoint
- Working knowledge of drug development
- Customer-service approach with flexibility and a team mindset
- Sustained attention to detail and accuracy
- Fluent spoken and written English
- Travel of 60 to 70 percent
Qualifications
- Clinical research experience or a related background
- Strong organizational skills
- Capacity to be productive while working from a home base
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this role remote?
The listing is marked remote, and the posting asks for someone who can work efficiently from a remote setup.
How much travel is involved?
The posting requires travel of 60 to 70 percent.
What experience is required?
At least three and a half years of site monitoring is needed, including oncology and global trial experience.
Is a salary listed?
The posting does not specify a salary or benefits.
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