Job Description

Mission:

Management of all aspects of Clinical Trial activities for assigned project(s). The Site Startup Specialist will work closely with internal and external stakeholders to support prompt delivery throughout the life cycle of each study project. Ensuring that all project deliverables meet the client/contract expectations, adhering to company standards/processes while ensuring overall client satisfaction.

Essential Duties and Responsibilities:

Including, but not limited to the following:

• Interface with Client representatives as well as staff members in functional departments to ensure the timely initiation and completion of clinical trials.
• Identifies potential bottlenecks and/or delays in Start Up and Enrollment; develops and executes contingency plans in order to keep the project on schedule.
• Coordinates client meetings (PSV or SIV).
• Schedules and hold internal meetings to include but not limited to: Kick-Off Meetings (KOMs), and weekly calls for all M3 sites.
• Takes and shares meeting minutes.
• Conducts daily, on-going communication via telephone and email, responding to inquiries and client requests.
• Keeps track and enters pertinent information such as study timelines dates in systems (CTMS, Salesforce, ShareFile), as well as department’s internal trackers.
• Review draft ICFs for all required elements prior to IRB submission.

Qualifications

Education and Training Required: Associate degree (2-year program) or equivalent level of education required; Bachelor’s Degree (4 year program) in a related field preferred.

Minimum Experience:

• 1-2 years or more of clinical research experience within a Clinical Research Site/Network or Contract Research Organization (CRO).
• Understanding of clinical research process and pharmaceutical development lifecycle.
• Experience with Salesforce and Clinical Conductor. Excellent oral and communication skills.
• Mastery skills in Microsoft Word, Excel, and/or other data management tools.
• Understanding of clinical and site logistics, as well as study start-up and site activation.
• Preferred previous knowledge with clinical trials CTMS (Clinical Conductor), Salesforce, and Florence e-regulatory portal.

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

M3 USA is an equal opportunity employer, committed to the principles of inclusion and diversity for all employees and to providing employees with a work environment free of discrimination and harassment.

All employment decisions at M3 USA are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical or mental disability, medical history or genetic information, sexual orientation, gender identity and/or expression, marital status, past or present military service, family or parental status, or any other status protected by the federal, state or local laws or regulations in the locations where we operate.

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