Competitive
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Job type
Salary
Competitive
Sector
Posted
18 days ago
Medpace is a full-service clinical contract research organization providing clinical development services to the biotechnology, pharmaceutical, and medical device industries. The Experienced Clinical Research Associate will conduct site visits, monitor clinical research activities, verify study data and documentation, and support compliance with protocols, SOPs, GCP, and applicable regulations.
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol
Communication with the medical site staff including coordinators, clinical research physicians, and their site staff
Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements
On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward
Verification the investigator is enrolling only eligible subjects
Regulatory document review
Medical device and/or investigational product/drug accountability and inventory
Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement
Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance
Benefits
Competitive travel bonus
Equity/Stock option program
Training completion and retention bonus
Annual merit increases
401K matching
Opportunity to work from home
Flexible work hours across days within a week
Retain airline reward miles and hotel reward points
Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere
In-house travel agents, reimbursement for airline club membership, and TSA pre-check
Opportunity for leadership positions – Lead CRA, CRA Manager, Training and Development Manager, and many more
User friendly CTMS with electronic submission and approval of monitoring visit reports
Customized, expedited PACE® training program based on your experience, therapeutic background, and interest
Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts
In-house administrative support for all levels of CRA
Opportunity to work with international team of CRAs
Office based environment with on-site mentors
Defined career paths with clear advancement opportunities
Industry renowned onboarding and training programs designed to accelerate professional development
Ongoing training and continuous learning opportunities throughout your career
An environment that encourages employees to influence change, contribute ideas, and grow quickly
Comprehensive health, wellness, retirement, and PTO benefits
Office based culture with occasional WFH that provides flexibility for eligible positions after training
Company-sponsored social events and intramural sports
A modern corporate campus designed to support collaboration and productivity
Multiple on-site dining options in the heart of Madison Square
Free on-site parking
Convenient access to on-site 24-7 fitness and wellness facilities
Company
Full-service clinical research organization for biotech, pharma, and medical devices
Cincinnati, Ohio, USA
http://www.medpace.com/
Founded in 1992
5001-10000 employees
Qualifications
Clinical Research Associate Experience (minimum 1 year)
Ability to travel 60-70% to locations nationwide is required
Minimum of a bachelor's degree in a health or science related field
Proficient knowledge of Microsoft Office
Strong communication and presentation skills
Detail-oriented and efficient in time management
Required skills
Represents the skills you have, click on the tags
Experience
1+ years
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