Essential Functions

Essential functions include, but are not limited to the following:

§  Assist in the design, planning and ensures the  implementation of clinical research projects

§  Assist in the development of protocols, Investigator Brochures, case report forms, informed consents, study manuals and study –related documents.

§  Negotiate and assists in finalizing site contracts and budgets, manage and calculate site payments

§  Perform site visits including site qualification, initiation, monitoring and close-out visits; co-monitor with regional monitors and review monitoring reports

§  Ensure adherence to the protocol providing for accurate data collection, documenting drug accountability and compliance with federal regulations

§  Maintain frequent site contact; prepare and track required documentation and manage study supplies at clinical sites

§  Oversee and track project progress at assigned sites (patient status, safety/adverse events, CRF completion, payments, study drug supply, regulatory documents).

§  Review data listings on an ongoing basis

§  Assist in planning Investigator Meetings

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

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

§  Provide guidance and mentors lower-level Clinical Research Associates and Clinical Assistants.

§  Over-all, exercises judgment within defined clinical practices and in accordance with the corporate policies and procedures in selecting methods, techniques and evaluation criteria for obtaining desired results.

Background Qualifications:       

• 5-8-years experience in conducting clinical trials
• BA/BS degree in a nursing, pharmacy, life sciences or health-related discipline is required
• 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
• A team player
• 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