<p>JOB SUMMARY - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.</p> <p>This position supports clinical activity for AngioDynamics' product portfolio; overseeing clinical and preclinical research for the company as well as assisting in the development of policies and procedures to support the organization's growing clinical pipeline. This position supports the execution of both sponsored and investigator-led trials for the Company under the direction of the Director, Clinical Affairs, part of the Clinical Affairs department. The Clinical Affairs Associate assists in ensuring all clinical activities are executed in a cost and time effective way, while assuring quality and Good Clinical Practice (GCP) compliance.</p> <p>This person will serve as a critical liaison between internal stakeholders as well as investigators, study coordinators, consultants, and key opinion leaders in order to ensure execution of the Company's scientific strategy.</p> <p>Essential Duties and Responsibilities</p> <ul> <li>Participate in the development of clinical strategy as directed by Director, Clinical Affairs </li><li>Execute clinical projects including the following activities: project planning and clinical study design development; collaborating with cross functional groups with varied functional expertise; establishing and monitoring clinical timelines and budgets. </li><li>Provide day-to-day support to project resources (Data Managers, CROs, vendors, consultants, etc.) </li><li>Participate in the development of clinical documents, including study protocols, case report forms, informed consent forms, clinical study agreements, reports and all other required documentation. </li><li>Facilitate investigator relationships: Participate in the qualification and screening of investigational sites, oversee site training and contract negotiation and serve as a senior clinical representative at investigator meetings. </li><li>Assist with the preparation of pre-IDE and IDE submissions and other interactions with the FDA. </li><li>Participate in the development of standard operating procedures in compliance with all applicable requirements and guidelines (e.g., GCPs). </li><li>Drive proactive, comprehensive clinical study communication to cross functional teams ensuring visibility of the group within the broader organization. </li><li>May perform other duties as assigned. </li></ul> <p>QUALIFICATIONS -The requirements listed below are representative of the knowledge, skill or ability required.</p> <p>Education and Experience</p> <ul> <li>Bachelor Level of Degree in the Biology, Health Sciences or related field of study </li><li>Equivalent work-related experience acceptable in lieu of degree: No </li><li>1-3 years of demonstrated experience in medical device field </li><li>No Certifications Required </li><li>Any preferred education, experience or certifications: Cardiovascular, Oncology and/or Vascular experience desirable </li></ul> <p>Skills/Knowledge</p> <ul> <li>Direct experience in the management of clinical research service providers </li><li>Excellent attention to detail and accuracy </li><li>Understanding of GCP, familiarity with GLPs </li><li>Proficient in the following computer software applications: MS Office products and other technology to document data and provide reporting </li><li>Exceptional interpersonal skills </li><li>Strong organizational skills </li><li>Strong communication skills (written and verbal) </li><li>Ability to effectively communicate both internally and externally. </li><li>Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. </li><li>This position requires some travel up to 25% of the time </li></ul>