Essential Functions:

Include and are not limited to the following:

§  Actively participates in ensuring that the Department goals are met to achieve the Corporate goals and objectives

§  Actively participates  in the design, planning and implementation of clinical research projects, including drafting project plans and timelines

§  Assists in the development of protocols, study budgets,  Investigator Brochures, case report forms, informed consents, study manuals and study-related documents

§  Negotiate and finalize site contracts and budgets overseeing that site payments are accurate and timely

§  Ensure that sites comply with study protocol and federal regulations

§  Oversee and track project progress of assigned study sites

§  Perform site visits including site qualification, initiation, monitoring and close-out visits

§  Maintain frequent site contact; and prepare, track, and manage required study documentation and supplies

§  Review data listings on an ongoing basis ensuring the accuracy  and completeness of  data collection

§  Determine and oversee site drug requirements and accountability and other supply requirements

§  Plan and coordinate Investigator Meetings

§  Assist in preparing interim study analyses, annual reports, and clinical study reports

§  Participates in the reviews draft statistical reports for accuracy and consistency

§  Manage external vendors, develop study specifications, and finalize vendor contracts; vendors may include and are not limited to Contract Research Organizations (CROs), central laboratories, interactive voice response service for randomization (IVRS)

§  Assists in the hiring and training of regional monitors; may function as a Lead CRA when necessary.

§  Mentor and train junior Clinical Research Associates

§  Over-all, exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining desired results

Background Qualifications:

• 8-12 years experience in conducting clinical trials
• BA/BS degree in a nursing, pharmacy, life sciences or health-related discipline is required
• Post-graduate course in health-related discipline is desirable
• Knowledge of FDA regulations, GCP and ICH guidelines is required
• Proficiency with MS Word, Excel, Outlook, and PowerPoint and technology related to the study activities (eClinical, IVRS, EDC, etc)
• Experience in managing CROs and other vendors
• Excellent communication and interpersonal skills
• Able to lead teams and motivate team members
• Must be willing to travel as required

Other knowledge and Skills Required:

§  Experience in and strong understanding of clinical trial design.

§  Strong team player.  Ability to work independently and in a multidisciplinary project team environment, including interactions with external vendors and CROs.

§  Attention to detail, accuracy, and strong organizational and problem-solving skills.

§  Leadership skills as well as demonstrated clear and concise verbal and written communication skills.

§  Ability to influence others effectively.

§  Ability to skillfully manage competing priorities and projects and handle multiple tasks simultaneously.

§  Dedication to quality and reliability in all work tasks.

§  Self-motivation, eagerness to grow professionally and commitment to self-development.

§  Able to prioritize and handle multiple tasks

To apply please send resumes to sreed@criticalresource.net