Process Research Director jobs in Lewiston, ME

Overview

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Summary:

• Provide overall medical leadership for the clinical trial site. Supervise the clinical trial team and act as a resource for investigators. Act as the lead medical consultant for the site’s business and commercial development.

Responsibilities

Duties/Responsibilities:

• Oversee and manage site Principal Investigators and Sub-Investigators, Quality, Competency, Oversight, and Training
• Ensure that the safety and well-being of all participants in the study at the trial site are protected
• Commercial (Business) development for the site
• Work closely with Business Development and Business Operations to acquire new studies for the site
• Liaise with Pharmaceutical and CRO Medical Directors to discuss new study opportunities
• Provide clinical content, insight and consulting expertise on protocol study design to sponsors and CROs
• Develop and maintain relationships with hospital staff and medical groups ensuring a positive flow of patient referrals and clinical study support
• Work closely with Site Director of Clinical Operations on clinical quality interacting with PIs, Sub-Is, and CRCs
• Serve as the medical authority regarding clinical quality practices and personnel at the site
• Ensure adherence to quality standards and good clinical practices
• Facilitate relationships with specialist community physicians for patient recruitment and/or PI/Sub-I purposes
• To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below above are representative of the knowledge, skill, and/or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Qualifications

Required Skills/Abilities:

• Thorough knowledge of clinical medicine, procedures, and techniques necessary for performing research tasks
• Knowledge of medical science and the development of clinical research programs
• Experience in the design of clinical research trials
• Excellent communication skills with the ability to interact with Principal Investigators, Sub-Investigators, Director of Clinical Operations, Clinical Research Coordinators and Sponsor personnel
• Excellent verbal, written and interpersonal skills
• Ability to travel for work related purposes (Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.)

Education and Experience:

• Minimum qualifications include an M.D or D.O with an active medical license (Medical license must be valid in the state in which the research is conducted).
• Training and certification in GCP (Good Clinical Practice)
• Board certification or board eligibility (in a specialty appropriate to the type of research being conducted at the site).
• Training and certification in Velocity required trainings and Standard Operating Procedures (SOP’s).
• Two or more years of Principal Investigator (PI) experience is strongly preferred but not required.