Medical Director- Principal Investigator; PI

Medical Director

The Medical Director functions as a Principal or Sub-Investigator for clinical trials being conducted at a clinical research site. Serve as Sub-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, Decentralized Trials (DCT) and study sponsors.

Responsibilities include:

• Function as PI or Sub-I 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 Market Place 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, and 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 Elligo, 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 or DO
• Current and Active license to practice medicine in TX
• 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 shortterm 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

Working Conditions:

This job operates in a professional clinical research office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

The clinical work environment involves exposure to potentially dangerous materials and situations that require extensive safety precautions and may include the use of protective equipment. Additionally, will work with blood or blood-borne pathogens.

Some flexibility in hours is allowed, but the employee must be available during the "core" work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.

Less than 10% travel may be required to support the position's responsibilities

Physical Demands:

• Regularly work at a desk using a computer for prolonged periods.
• Perform repetitive motion with substantial movements (motions) of the wrists, hands, and/or fingers.
• Regularly communicate via e-mail, telephone, chat, webcam (remote sessions such as MS Teams or Zoom), so others will understand and exchange accurate and timely information.
• Ability to give and receive information through speaking and listening.
• Frequently stand/walk, grasp…