Principal Investigator

Principal Investigator / Medical Director

Summary:

The Medical Director functions as a Principal Investigator (PI) for clinical trials being conducted at a clinical research site. Serve as Principal Investigator on decentralized/hybrid clinical trials. Functions as a part of the Medical Affairs Department to provide medical and scientific support to Elligo functional areas, clinical trial investigators/sites and study sponsors.

This will be a long term contract (6-12 months) with part-time hours of 20-25 hours a week

Family Medicine and or Internal Medicine experiences and exposures in needed

Responsibilities:

• Function as PI for site based and/or decentralized/hybrid clinical trials, providing input into operational planning to ensure appropriate PI oversight with attention to patient safety and data integrity.
• Provide training as indicated to site staff in coordination with Site Director.
• Support and foster collaborative agreements and interactions with local practices/physicians/physician groups/medical providers to facilitate patient
• enrollment in coordination with the Site Director.
• Monitor Study MarketPlace for potential studies and respond to feasibilities in a timely manner.
• Maintain knowledge and clinical expertise in relevant therapeutic areas.
• Provides thorough review of protocol and other study materials
• Determines clinical and practical “fit” for our practice partner sites by assessing study complexity, logistics, etc.
• Collaborate with Trial Placement and Operations to determine which studies are appropriate for which sites/investigators
• Interact with potential, onboarding, existing sites and investigators as requested by Research Operations, Decentralized Trial team and Site Account Managers.
• May travel to sites as needed
• Provide therapeutic and protocol specific training and supporting material for project teams and local investigators as indicated, and for internal operations needs
• Prepares risk assessment to determine potential pitfalls and issues that may occur during studies
• Participates in the development and medical review of recruitment and enrollment strategies and material.
• Provides medical and scientific knowledge on products and therapeutic areas to inform future growth.
• Interacts with outside medical experts as required.
• Provide input and participate in technology and other strategic committees as appropriate.
• Follows ethical and professional codes of conduct and escalate noncompliance as needed
• Comply with Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines and documents data according to ALCOA.
• Perform other duties as required to support requests to medical affairs

Knowledge Skills and Abilities Required:

• MD, DO or advanced practice degree (NP, PA)
• Current and Active license to practice medicine in the US or requisite training and experience
• 3-5 years healthcare experience in a US community practice setting
• Preference will be given to candidates with clinical experience in health research settings as a Principal or Sub-Investigator
• Expertise regarding applicable compliance requirements.
• Strong scientific, analytical and problem-solving skills, strategic thinking capabilities, project management, planning and organizational skills and excellent communication and presentation skills.
• Collaborative spirit and dedication to team accomplishments, perseverance to overcome short term challenges and accomplish long-term objectives.
• Demonstrated ability to work collaboratively with cross functional departments/groups
• Ability to independently and collaboratively create and manage project management plans related to the job requirements
• Effective verbal, written and interpersonal skills
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems
• Strong organization/prioritization skills for the management of multiple concurrent projects and tasks

Requirements:

• MD, DO or advanced practice degree (NP, PA)
• Current and Active license to practice medicine in the US or requisite training and experience
• 3-5 years healthcare experience in a US community practice setting
• Preference will be given to candidates with clinical experience in health research settings as a Principal or Sub-Investigator
• Expertise regarding applicable compliance requirements.
• Strong scientific, analytical and problem-solving skills, strategic thinking capabilities, project management, planning and organizational skills and excellent communication and presentation skills.
• Collaborative spirit and dedication to team accomplishments, perseverance to overcome short term challenges and accomplish long-term objectives.
• Demonstrated ability to work collaboratively with cross functional departments/groups
• Ability to independently and collaboratively create and manage project management plans related to the job requirements
• Effective verbal, written and interpersonal skills
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems
• Strong organization/prioritization skills for the management of multiple concurrent projects and tasks