Process Research Director jobs in Fall River, MA

JOB SUMMARY
​​​The Medical Director functions as a part of the Medical Affairs Department to provide medical and scientific support to Elligo functional areas, clinical trial investigators and study sponsors. To serve as Principal or Sub-Investigator on decentralized clinical trials.

This position will also include functioning as a Principal Investigator for studies being conducted at the Elligo Clinical Research Center.

RESPONSIBILITES

• Serve as Principal Investigator (PI) on clinical trials conducted at the Elligo Clinical Research Center.
• Responsible for the conduct of clinical trials per GCP/HSP guidelines to ensure participant safety, data integrity and responsibility for study staff
• 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 Feasibility 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.
• Function as PI or Sub-I for decentralized clinical trials, providing input into operational planning to ensure appropriate PI oversight with attention to patient safety and data integrity.
• ​​​​Interacts with outside medical experts as required.
• Provide input and participate in technology and other strategic committees as appropriate.

KNOWLEDGE SKILLS AND ABILITIES REQUIRED

• MD, or DO
• Current and Active license to practice medicine in the US or requisite training and experience
• 3-5years healthcare experience in a US community practice setting
• Preference will be given to candidates with experience in clinical research settings as a Principal or Sub-Investigator
• Preference given to FM, IM/Peds, ER physicians who are comfortable with adult and pediatric population
• 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

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

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.

Travel: Minimal

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.