Clinical Study Associate II

Atricure, Inc. - Cincinnati, OH

Posted: 4/10/2024 - Expires: 7/9/2024

Job ID: 272222191

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Job Description

Clinical Study Associate II

Cincinnati, OH, USA * Mason, OH, USA * Minneapolis, MN, USA * Minnetonka, MN, USA
Req #2020

Monday, April 8, 2024

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

POSITION SUMMARY:

This position will be a key contributor to AtriCure's clinical affairs department to assist in the development, implementation, and execution of multiple key study functions. The Clinical Study Associate primary responsibilities include but are not limited to supporting device supply logistics, financial processes (contracts, budgets, and invoices), essential document and trial master file (TMF) management and select monitoring activities. The Clinical Associate is a key contributor to AtriCure' s clinical affairs department to assist in the development, implementation, and execution of departmental needs and key study functions. In addition, this position will provide administrative support as needed. The position requires a skilled, professional person who can work well in a matrix team environment and readily adapt as departmental and study needs change over time. Independent judgment is required to plan, prioritize and organize a diversified workload with support/direction from management. Team collaboration and willingness to take on and learn new tasks will also be a key asset critical to success.

ESSENTIAL FUNCTIONS OF THE POSITION:

Responsible for set-up of the electronic trial master file (eTMF), assists in collection and quality control of documents, files clinical trial documents, and assists in maintenance and ongoing tracking of clinical documents
Leads and supports clinical team as needed in identification, creation, documentation, and maintenance of processes required for conduct of a clinical trial
Responsible for tracking study activity in collaboration with the clinical team, such as start-up process by ensuring receipt of proper documentation, agreements, and site approvals
Responsible for developing, coordinating, managing device processes and logistics from demand planning, device setup in the clinical database, ordering, re-supply and tracking for study sites including quality control and filing of documents
Facilitates execution of study contracts and budgets (help as needed to move contracts and agreements through the signature process, limited quality control reviews, record keeping associated with executed contracts)
Collaborates with Clinical Project Manager and Clinical Operations Associate to track accruals, processing and reconciliation of payments
Responsible for working with Clinical Research Associates (CRAs) in performing monitoring preparation activities and potentially assist in select monitoring activities at local investigational sites
Create, run and monitor metrics and maintenance reports on an ongoing basis
Leads and facilitates Investigator/Clinical meeting logistics and planning (including arranging meeting rooms, scheduling teleconferences, preparing and distributing meeting agendas, record, prepare and distribute meeting minutes as needed)
Leads clinical trial materials development and management (may include ordering, copying, creating tabs, building binders, review binder content, shipping, and tracking of documents associated with department or study supplies and study devices)
Works with clinical teams to create and distribute study newsletters and communications to sites
Participate in project team meetings and other departmental development initiatives (e.g. training, Standard Operating Procedure (SOP) development process/updates)
Leads process improvement efforts to enhance systems and timelines
Solves problems of moderate scope and complexity following established policies and procedures

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

Regular and predictable work performance
Ability to work under fast-paced conditions
Ability to make decisions and use good judgement
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned

BASIC QUALIFICATIONS:

Bachelor's degree preferred
2-5 years of relative experience
Proficient with MS Word, MS Excel, and PowerPoint
Strong attention to detail
Excellent written and verbal communication skills
Excellent organizational and time management skills
Understanding of the administrative aspects of document management
Ability to effectively manage/prioritize multiple projects
Ability to create and manage internal and external partnerships
Experience working in clinical trial master files/databases
Problem solving/troubleshooting experience
Basic knowledge of Good Clinical Practices and regulatory compliance for clinical trials
Ability to respond flexibly and positively under conditions of uncertainty or change

PREFERRED QUALIFICATIONS:

Experience in the medical device or pharmaceutical industry
Flexibility and willingness to learn new skills, processes, and computer systems
Clinical Research Organization (CRO) experience desired

OTHER REQUIREMENTS:

Ability to regularly walk, sit, or stand as needed
Ability to occasionally bend and push/pull as needed

Occasionally lift up to 25 pounds

Ability to pass pre-employment drug screen and background check

#LI-RW1

AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Other details

Job Family
Clinical Development

Job Function
Clinical

Pay Type
Salary

Employment Indicator
Non Manager

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.

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Job Summary

Employment Type:: Full Time Employee
Job type:: Federal Contractor
Skill Based Partner:: No
Education Level:: No school grade completed
Work Days:: Mon, Tue, Wed, Thu, Fri
Job Reference Code: 78989962
Salary: N/A
Licenses / Certifications:: N/A; N/A

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Clinical Study Associate II

Atricure, Inc. - Cincinnati, OH

Job Description

Job Summary