Job description

Sr. Clinical Research Specialist (12 month contract // REMOTE, team based in Boulder, CO):

Preferred candidates from local area but open to both remote possibilities as well.

Top skills needed:

Good understanding and critical experience in clinical study/research management for Medical Devices

Experience overseeing clinical study operations, including safety, monitoring, data management, and site and vendor selection.

Experience in writing clinical protocols and clinical site management experience

Candidate should have strong awareness of GCP requirements

Duties:

• Oversees, designs, plans and develops clinical research studies. May be involved in early study development including statistical design of the trial.
• Prepares and authors protocols and patient record forms.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Assists in overseeing and interpreting results of clinical investigations in preparation for new drug device or consumer application.
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
• Oversees clinical study operations, including safety, monitoring, data management, and site and vendor selection.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Escalates any study issues quickly to leadership and ensures study milestones are met.
• Maintains understanding of regulatory requirements across multiple regions; serves as resource for clinical strategy personnel.
• May represent Clinical Affairs team on certain product core teams providing SME support with clinical requirements in accordance with SOPs and regulations.

Other Responsibilities:

• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and management.
• Reviews status of projects and budgets; manages schedules and prepares status reports.
• Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
• Develops mechanisms for monitoring project progress and for intervention and problem solving
• Present to and partner with clinical leadership on the overall health of the portfolio, successes, and areas of opportunity.

Required Knowledge and Experience:

• Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Job Types: Full-time, Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• medical device industry: 4 years (Preferred)
• clinical study and research management: 4 years (Preferred)
• safety, monitoring, data management: 4 years (Preferred)
• vendor/site selection: 4 years (Preferred)
• clinical protocols, site management: 4 years (Preferred)
• GCP: 4 years (Preferred)

Work Location: Remote

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