Study Start Up Assistant (Part/ Full Time)

Study Start Up North Carolina


Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. 

We’re looking for an exceptional Study Start Up Assistant (Part/ Full Time) to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.  

At Premier Research, we are science-minded and heart-centered. Join us.

The Assistant will learn about the history of Premier Research and their role within the pharmaceutical research and development industry. They will also be assigned specific tasks under the direction of the Clinical Operations/Clinical Start Up and Planning Managers. The student will benefit by applying the knowledge acquired in their college coursework to hands on career experiences provided by Premier Research staff and mentors.

What you'll be doing:

· Assist team members with the completion of project specific tasks

· Reviews required documentation to ensure site activation per timeline

· Communicates with site personnel to obtain information necessary to determine site participation in a clinical trial

· Attends meetings and other learning opportunities

· Prepares and maintains documentation, plans, reports, schedules, databases, spreadsheets, logs, etc. to support functions.

· Compiles, prepares and analyzes data and prepares reports. Provides administrative assistance for special projects as required by the Clinical Operations Management teams

· Communicate with both internal and external personnel as required.

· Attending departmental specific training

· Other tasks under the direction of other Premier Research mentors and/or management

What you'll Need:

· Must be enrolled in an Associate, Undergraduate or Graduate program or recent graduate of a higher learning institution.

· Good computer literacy and knowledge of MS Word, Excel, PowerPoint

· Must possess strong written and verbal communication, interpersonal, and organization skills

· Knowledge of ICH / GCP regulations helpful

· Knowledge of clinical research process and medical terminology

· Strong written and verbal skills to express complex ideas to study personnel at research and clinical institutions

· Ability to reason independently to assess and recommend specific solutions in clinical settings

· Ability to work as a team member and interact with sites in a professional and courteous manner.

· Full-time availability to internal and external project team members

· Fluent verbal and written English

· Excellent team player, collaborative and able to enable an effective team

· Ability to multitask and work effectively in a fast-paced environment with changing priorities

· Strong verbal and written communication skills

· Excellent organizational and time-management skills, able to meet deadlines

· Self-starter with lots of common sense and able to act on own initiative

· Accountable, dependable and strong commitment

· Applies clear and consistent performance standards and handles problems decisively and objectively

· Customer service focused in approach to work, both internally and externally

· Maintains a positive, results orientated work environment