Clinical Affairs Associate

Clinical Affairs Associate

This position is on-site at our Fulton Market office in Chicago, IL, and we are looking for good people who want to be a part of the amazing culture here at Alma!

Summary

The primary responsibility of the Clinical Affairs Associate is to assist in the planning and executing of Alma’s Clinical Affairs activities. In this position, you will integrate scientific and clinical knowledge to support the successful execution of clinical studies in compliance with investigational plans, applicable regulations, and in line with identified business goals and objectives by coordinating with internal and external stakeholders while providing logistical support throughout the entire process.

Essential Functions

• Demonstrated ability to plan, implement, and manage multiple projects in a fast-paced environment
• Strong analytic skills for strategic review and assessment of the medical literature, clinical and statistical data interpretation and scientific study proposals and oversee data management activities
• Assist in supervising study sites and research activities to ensure adherence to protocols and terms of the study
• Monitor the progress of the project and update clinical project leader on an ongoing basis
• Create and/or maintain research activity records which may include meeting minutes, data collection tools, metrics reports, regulatory forms, dispensation records, consent forms, case reports, or others as needed
• Contribute to medical writing activities including abstracts, white papers, educational assets, the preparation of clinical documents, study design protocols, and others as needed
• Establish and maintain long-term collaborative relationships with clinical trial investigators, their research staff, and KOLs
• Other responsibilities as set forth by the Director of Clinical Affairs

Competencies

• Exceptional oral and written communication skills including active listening, presentation, and interpersonal communication
• Excellent organization, attention to detail, and ability to maintain detailed and accurate records
• Proven capacity to manage up, down, and across internal and external stakeholders to produce desired outcomes, facilitate growth, and create value
• Proactive, energetic, self-assured professional with personal integrity, the ability to develop healthy interpersonal relationships, and a desire for continual personal development
• Ability to provide technical guidance and support to professional staff where needed
• Ability to use positive influence and persuasion to motivate people effectively while building respect and rapport, including relationships with trial center colleagues and staff

Education and Experience Required

• BA/BS degree in biology, health science, or another related field required. Master’s or advanced degree desirable.
• Prior experience as a clinician, with clinical research, and energy-based devices is preferred
• Clinical research certification highly desirable

Skills Required

• Ability to manage time and resources to prioritize tasks and accomplish set goals efficiently
• Successfully navigate in a fast-paced environment with changing priorities and constraints
• Ability to collaborate, and contribute both as an individual and as a team member
• Strong problem solving, deductive reasoning, and decision-making skills
• Knowledge of Microsoft Office applications such as MS Word, Excel, and PowerPoint, project management software, cloud-based systems, etc.
• Knowledge of medical device development, clinical trial management, and the application of appropriate FDA, GCP, and ISO Standards to meet regulatory and compliance requirements

Supervisory Responsibility

This position has no direct reports.

Work Environment

This job operates in a professional office environment, including travel to clinical trial sites. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally life and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Equal Opportunity Employment:

We're proud to be an equal opportunity employer and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status.

E-Verification:

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.