Remote opportunity at
Precision Medicine GroupClinical Research Associate II - FSP
Precision Medicine Group is hiring a Clinical Research Associate II - FSP to join its organization. The company operates as a precision medicine contract research organization,…
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About This Role
Precision Medicine Group is hiring a Clinical Research Associate II - FSP to join its organization. The company operates as a precision medicine contract research organization, combining adaptive clinical trial designs, medical experts, advanced biomarkers, and data analytics to support targeted therapies, particularly in oncology and complex diseases. This role suits an experienced clinical research professional looking for involvement in monitoring and site management within a mid-sized organization. In this…
Job Description
Precision Medicine Group is hiring a Clinical Research Associate II - FSP to join its organization. The company operates as a precision medicine contract research organization, combining adaptive clinical trial designs, medical experts, advanced biomarkers, and data analytics to support targeted therapies, particularly in oncology and complex diseases. This role suits an experienced clinical research professional looking for involvement in monitoring and site management within a mid-sized organization.
In this position, the practitioner independently manages study sites to protect patient safety, maintain data quality, and support audit readiness. Responsibilities span study implementation, on-site and remote monitoring visits, investigator site file oversight, and investigational product management. The individual also assists with startup procedures, site recruitment, and safety reporting while collaborating with project teams and sponsor representatives. The role involves managing risks, communicating issues proactively, and maintaining strong investigator relationships.
The position requires an average of up to 60 percent travel, including overnight and potential international travel based on regional needs. The organization offers a total rewards package that includes health offerings, retirement plans with a company match, paid parental leave, and paid time off.
Responsibilities
- Manage all facets of study site operations to safeguard patient data quality and safety
- Prepare sites for audits and execute necessary follow-up actions
- Maintain, update, and track study trial management systems and status reports
- Conduct qualification, initiation, monitoring, and close-out visits both on-site and remotely
- Verify informed consent documentation and evaluate factors impacting data integrity and subject safety
- Draft and submit timely trip reports, confirmation letters, and follow-up communications
- Reconcile investigator site files with the trial master file and ensure archiving compliance
- Review investigational product inventory, reconciliation, storage, security, and administration
- Identify and escalate study risks while resolving discrepancies in electronic data capture systems
- Process serious adverse events and support recruitment, retention, and awareness initiatives
Requirements
- Hold a 4-year college degree or equivalent education in a healthcare or scientific discipline
- Demonstrate at least two years of experience as a clinical research associate at a contract research organization or equivalent setting
- Possess site management or relevant clinical research experience
- Use electronic spreadsheets, computerized information systems, word processing, and email proficiently
- Fulfill regional travel requirements averaging up to 60 percent, including overnight and international trips
- Demonstrate fluency in English, alongside the local language of the employment country if non-English speaking
- Maintain legal authorization to work in the employment country without sponsorship
Qualifications
- Earned a graduate or postgraduate degree
- Bring prior experience monitoring lupus studies or rare and complex therapeutic areas
- Have experience monitoring electronic data capture trials and electronic health records
- Show background in biopharma or relevant therapeutic areas
- Possess country-specific experience in site startup tasks such as feasibility, contract negotiations, and ethics submissions
- Demonstrate proficiency in conducting formal presentations to diverse audiences
Core Skills
Benefits
- Paid time off and volunteer time off
- Comprehensive medical coverage
- Non-vested 401k plan featuring a company match
- Paid parental leave
- Discretionary annual bonus
- Life insurance and disability benefits
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the salary range for this role?
The compensation range is specified as USD 91,500 to USD 137,300 per year, with eligibility for a discretionary annual bonus.
How much travel is required for this position?
The role requires an average of up to 60 percent travel, including overnight stays and potential international travel according to project needs.
What level of experience is needed to apply?
Candidates must have a 4-year college degree or equivalent in a scientific or healthcare discipline, along with a minimum of two years of experience as a clinical research associate in a contract research organization or equivalent environment.
Does the job posting specify if the position is remote?
The posting lists the employment type as full-time and remote status as remote.
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