Remote opportunity at
pfm medical, inc.Clinical Research Associate II - FSP
Precision for Medicine is a precision medicine contract research organization that combines novel trial designs, operational experts, biomarker and data analytics solutions, and specialized expertise in…
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About This Role
Precision for Medicine is a precision medicine contract research organization that combines novel trial designs, operational experts, biomarker and data analytics solutions, and specialized expertise in complex disease states to support oncology development. The company is hiring a Clinical Research Associate II for a full-time position with a salary range of USD 91,500 to 137,300 per year. This role is a seasoned professional position focused on monitoring and site management.…
Job Description
Precision for Medicine is a precision medicine contract research organization that combines novel trial designs, operational experts, biomarker and data analytics solutions, and specialized expertise in complex disease states to support oncology development. The company is hiring a Clinical Research Associate II for a full-time position with a salary range of USD 91,500 to 137,300 per year.
This role is a seasoned professional position focused on monitoring and site management. It suits individuals with clinical research experience who want influence in a mid-sized organization that offers reasonable travel and strong professional retention rates. The incumbent works independently as a study team member to oversee site management, protect patient safety, maintain data quality, and support audit readiness.
Responsibilities
- Oversee study site management aspects to protect patient safety and maintain low query levels and acceptable Quality Assurance reports
- Provide guidance on audit readiness standards and support preparation for audits and follow-up actions
- Update, track, and maintain trial management tools, systems, and status reports
- Manage site start-up procedures including investigator feasibility and recruitment, ethics committee and institutional review board submissions, and regulatory document collection
- Verify the informed consent process is adequately performed and documented for every patient
- Assess factors affecting patient safety and data integrity, such as protocol deviations and pharmacovigilance issues
- Conduct pre-study, qualification, initiation, routine monitoring, and close-out site visits
- Prepare and submit accurate and timely monitoring reports for all site visits
- Maintain project documents including confirmation letters, trip reports, and communication logs
- Support patient recruitment, retention, and awareness strategies
- Review Investigator Site Files for accuracy and reconcile contents with the Trial Master File
- Communicate proactively with site personnel and project management regarding protocol issues and deviations
- Perform investigational product inventory, reconciliation, storage review, and security checks
- Conduct data reviews including electronic data capture case report form reviews and query resolution
- Identify and process Serious Adverse Events and escalate site risks to management with contingency suggestions
Requirements
- Minimum of a four-year college degree or equivalent experience in a scientific or healthcare discipline
- Two or more years of experience as a clinical research associate in a contract research organization or equivalent relevant experience
- Experience in site management or clinical research
- Strong communication and organizational skills
- Proficiency with computerized information systems, electronic spreadsheets, word processing, and electronic mail
- Ability to travel overnight up to 60% on average, as well as international travel as needed
- Fluency in English and the local language of the country where the position is based
Qualifications
- Graduate or postgraduate degree
- Experience with lupus monitoring
- Experience monitoring in rare and complex therapeutic areas
- Experience monitoring electronic data capture trials and electronic health records
- Experience in biopharmaceutical or relevant therapeutic areas
- Site start-up experience including feasibility, contract negotiations, and submissions
Core Skills
Benefits
- Paid time off
- Volunteer time off
- Robust medical offerings
- Non-vested 401(k) plus company match
- Paid parental leave
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Paid leave for sick leave and vacation
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the salary for the Clinical Research Associate II position?
The salary range for this role is USD 91,500 to 137,300 per year, which is determined by factors such as skill sets, experience, training, certifications, and business needs.
What travel is required for this role?
The position requires overnight travel averaging up to 60% based on regional requirements, along with international travel as needed.
What education or experience is required to apply?
Applicants must have a four-year college degree or equivalent in a scientific or healthcare discipline, and at least two years of experience as a clinical research associate in a contract research organization or equivalent relevant experience.
What benefits are provided with this position?
Benefits include paid time off, volunteer time off, medical offerings, a non-vested 401(k) with company match, paid parental leave, a discretionary annual bonus, health insurance, life insurance, and disability benefits.
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