Sr. Clinical Research Specialist

Job Description

Duties and Responsibilities:

• Manage and oversee clinical study sites.
• Support site activation activities.
• Ensure compliance with GCP and Good Documentation Practices (GDP).
• Maintain strong engagement and communication with study sites.
• Support ongoing clinical study operations.
• Act as a senior team member and mentor junior staff.

Responsibilities may include the following and other duties may be assigned:

• Oversees, designs, plans and develops clinical evaluation research studies.
• Prepares and authors protocols and patient record forms.
• Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Oversees and interpret 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.
• May be responsible for clinical supply operations, site and vendor selection.

Differentiating Factors:

Autonomy:

• Seasoned individual contributor.
• Works independently under limited supervision to determine and develop approach to solutions.
• Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact:

• May be responsible for entire projects or processes within job area.
• Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity:

• Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
• Makes improvements of processes, systems or products to enhance performance of the job area.
• Analysis provided is in depth in nature and often provides recommendations on process improvements.

Communication and Influence:

• Communicates with senior internal and external customers and vendors.
• Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.

Leadership and Talent Management:

• May provide guidance, coaching and training to other employees within job area.
• May manage projects, requiring delegation of work and review of others’ work product.

Education:

• Bachelors required.

Required Knowledge and Experience:

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• May have practical knowledge of project management.
• Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• Clinical Research industry experience.
• Experience in study start up and site activation.
• Solid understanding of FDA regulations (21 CFR part 820).
• Strong site communications and management.

Preferred Knowledge and Experience:

• Experience with Audit (e.g. BIMO)-BIMO stands for the Bioresearch Monitoring Program
• 3 or more years of clinical research experience with industry sponsor.
• Preferred medical devices.
• Experience with site activation activities.
• Site management activities.

Interview Process:

• First Round Interview.
• Team Panel Interview.