Clinical Research Contract Specialist (Paralegal Preferred)

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.

Include

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.

• 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
• 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

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 Contract Speicalist at Wake Research, an M3 company. This is a remote or hybrid position.

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 26 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.

Mission of the Role:

The Clinical Research Contract Specialist is responsible for overseeing the negotiation of all non- government sponsored contract language and budget negotiation. Maintains current ongoing study contracts ensuring all amendments are captured. Communicates contracts status and metrics as needed.

Essential Duties And Responsibilities

Including, but not limited to the following:

• Assist with project evaluation specifically related to the feasibility of the budget.
• Collaborate with Finance and key operational team members to incorporate project status into projections.
• Support the reporting of KPIs, trends, and results.
• Work cross functionally with many departments at M3 Wake Research to fulfill internal and external requests.
• Develop, maintain, and analyze cost estimates for Phase l-IV clinical research projects from initial request through study closeout.

Qualifications

Requirements:

• 2+ years of experience of administrative, contract management or paralegal experience is required.
• CRO or site network experience
• Basic knowledge of medical terminology and a working knowledge of drug development services desired.
• Bachelor’s degree in a relevant field is strongly preferred.
• Excellent analytical, written, and oral communication skills.
• Working knowledge of financial and accounting processes.
• Prior experience work with clinical research site budgets.
• Strong decision -making and problem-solving skills.
• Comfortable reading and interpreting a key operation aspect of a clinical research protocol.
• Prior Paralegal or negotiation of contract language experience.
• Excellent organizational skills and the ability to multitask while efficiently and independently completing high quality work.
• Excellent computer skills with an advanced proficiency in Microsoft Excel.

Additional Information

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

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