Source Documents Specialist

Company Description

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Due to our continued growth, we are hiring for a Source Documents Specialist at Wake Research, an M3 company. This position is a remote position. 

Job Description

Mission of the Role:

The Source Documents 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
• Previous experience working as a Clinical Research Coordinator is strongly preferred
• 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

About M3: 

M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.

Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.

Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.

Benefits:

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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