Note: The job is a remote job and is open to candidates in USA. Medpace is a full-service clinical contract research organization providing clinical development services to the biotechnology, pharmaceutical, and medical device industries. The company is seeking experienced Clinical Research Coordinators to transition into home-based Clinical Research Associate roles through its PACE® training program, conducting site visits, monitoring clinical trials, verifying regulatory and clinical data, and ensuring compliance with protocols and applicable requirements.
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
Skills
Minimum of a Bachelor's degree in a health or science related field
Experience as a Clinical Research Coordinator (minimum 2 years)
Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely
A valid driver's license and the ability to drive to monitoring sites
Proficient knowledge of Microsoft Office
Strong communication and presentation skills
Detail-oriented and efficient in time management
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
CRA training program - PACE®
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
Medical, dental, and vision benefits for full-time positions
401(k) for full-time positions
Vacation policy, sick days, and paid holidays for full-time positions
Work from home flexibility for full-time positions
Short-term disability and long-term disability for full-time positions
Health savings and flexible savings accounts for full-time positions
Life and AD&D insurance for full-time positions
Pet insurance for full-time positions
Reimbursement for travel expenses, including food and gas allowance, rental cars, and hotel accommodations, for full-time positions
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
Company Overview
Medpace, Inc., a clinical research organization, provides clinical development services for pharmaceutical and biotechnology It was founded in 1992, and is headquartered in Cincinnati, Ohio, USA, with a workforce of 5001-10000 employees. Its website is
