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Full-time

Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

Competitive

Comprehensive health, wellness, retirement, and PTO benefitsScience & PharmaceuticalPosted 23d ago

You'll complete your application on the employer's website.

Job description

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 train as home-based Clinical Research Associates through its PACE® Training Program, with responsibilities including site monitoring, regulatory review, source data verification, and compliance oversight.

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

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

Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust

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

Competitive compensation programs that recognize and reward performance

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

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

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

Required skills

Represents the skills you have, click on the tags

Experience

2+ years

Interested in this role?

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