Source Documents Specialist Jobs

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. include:
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 Sourced Document Specialist at Wake Research, an M3 company. This is position is remote.
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 Source Document Specialist will perform review, quality control and publishing of templated source documents that adhere to regulations and ensure consistency with collection of source data to achieve the technical quality while complying with protocol guidelines and requirements.
Essential Duties and Responsibilities:
Review, and understanding, of protocol required elements as it related to the collection of source data.
Creation of source documents on a per trial basis that align with all protocol required assessments, EDC required elements, while taking into consideration sponsor feedback.
Creation of source documents that are in line with M3 Wake Research formatting and lends themselves to mitigation of error of omissions.
Creation of source documents that are formatted in a sensible manner that aide in the completion of the study visits in a logical and sensible fashion.
Creating source in a timely fashion, once study award has been granted, so as not to delay enrollment at any such awarded site.
Review and modification of source documents based upon participating sites’ feedback on the usability and accuracy of said source.
Submits all creations, amendments, and modifications to team members for quality control review and document finalization prior to site use.
Modifies existing, and approved source, based upon protocol amendments, and/or sponsor/site required edits.
Works closely with Project Management team to submit finalized source.
Qualifications
Requirements:
At least one year of clinical research experience
Excellent written and verbal communication skills.
Superb computer literacy with advanced knowledge and utilization of Microsoft office products.
Highly self-motivated, organized, and able to operate autonomously and multi-task in a fast-paced dynamic environment.
Detail oriented with an eye for formatting and layout.
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

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