Clinical Research Site Director

Company Description

M3 is the global leader in digital solutions in healthcare. We work with a range of sectors including healthcare, life sciences, pharmaceuticals, biotechnology and charities; services provided to these sectors include market research, medical education programs, promotional programs, clinical development, job recruitment and clinic appointment services. M3 has grown by more than 20% year-on-year for the past 15 years, achieving over 1 billion dollars in revenue annually.

Founded in 2000, with start-up investment capital from Sony, M3’s mission is to make use of the internet to increase, as much as possible, the number of people who can live longer and healthier lives, and to reduce, as much as possible, the amount of unnecessary medical costs.

Key achievements of M3 Inc.

• Named in Fortune’s 2020 ‘Future 50’ list, ahead of Facebook and Amazon
• Ranked in Forbes’ 2020 Global 2000 list of the world’s largest public companies
• M3 is the only company incorporated after the year 2000 to be included in the Nikkei 225 Index
• Listed in Forbes’ ‘Asia’s 200 Best Over a Billion’ in 2019
• In 2020 M3 founded the ‘M3: Stop COVID-19 Fund’ and pledged one billion yen to support COVID-19 related initiatives

M3’s legacy lies in the power of trusted physician platforms. Around the world, M3 organizations leverage these highly engaged digital communities to deliver medical education, job placement, and market research, to improve global patient outcomes.

Due to our continued growth, we are hiring for a Clinical Research Site Director at Wake Research, an M3 company. This position is on-site and located at our Fayetteville, NC site.

About The Business Division

M3 Wake Research, Inc. is one of the largest independent clinical research site services companies in North America. M3 Wake Research is an integrated network of premier investigational sites working closely with and meeting the needs of the global biopharmaceutical, biotechnology, medical device, pharmaceutical industry, and clinical research organizations. M3 Wake Research has its proprietary patient database of potential clinical trial participants—men and women, children and adults, across all ethnicities—for all kinds of adaptive and other types of trial designs. Conducting studies since 1984, we have a combined subject database of more than 2 million.

M3 Wake Research has 23 owned and managed research sites across 9 states in the US and continues to grow. As of today, our board-certified physicians have completed more than 7,000 successful clinical trials. Clinical trials at our site are always completed on time and with accuracy; we consistently exceed sponsor expectations for integrity, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Our approach is uncompromising – each study conducted at our site is carefully planned and executed according to regulations with superior quality.

Job Description

The Clinical Research Site Director oversees site activities to ensure delivery of site targets as received from senior management. The Clinical Research Site Director provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.

Essential Duties And Responsibilities

• Responsible for site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out
• Conducts pre-study site selection visits and assessments
• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct
• Schedules staff to cover subjects' visit needs
• Conducts staff reviews
• Works to ensure enrollment goals of the study center are being met
• Monitors subject visits
• Supports the team and investigators in overall conduct of the trials
• Follows the established monitoring SOPs both corporate and clinical, as well as protocol for specific monitoring plan
• Works with QA/QC program prior to sponsor visit
• Oversees employees' work before monitoring
• Reviews budgets, including clinical research and physicians' costs
• Works with the corporate office to evaluate recruitment plans and study start up
• Oversees protocol, regulations, and compliance training; ensures training is up to date
• Oversee the site financial performance
• Train and develop site staff. Ensure that site team understands and performs according to established KPI

Qualifications

• Bachelor's degree or equivalent and relevant formal academic experience.
• Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.
• 5 years of relevant experience as a clinical research associate or clinical research coordinator is required. Must have experience managing trials.
• Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.
• Strong written and verbal communication skills. An ability to consume, absorb, and analyze large amounts of information.
• Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams.
• Strong computer skills in appropriate software and related company clinical systems are required

Additional Information

A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:

• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance
• M3 reserves the right to change this job description to meet the business needs of the organization