Clinical Research Spec
6165 Gunbarrel Avenue Boulder, CO 80301 US
40-47.50/h pay depending on experience
Top skills needed: Good understanding and critical experience in clinical study/research management, experience in writing clinical protocols and clinical site management experience
Responsibilities may include the following and other duties may be assigned.
- 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.
- 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.
- 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.
- 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.
- Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
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 indepth 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 decisionmaking. 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 .
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.
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