Clinical Research Associate

Job Summary:

The experienced in-house Clinical Research Associate (CRA) will work closely with the Clinical Operations team in the study set-up, execution, and closeout to ensure study deliverables are met and compliance with clinical protocols, their objectives and ICH and GCP guidelines. The CRA will contribute to the development of trial protocols, establishes trial sites, train site staff, and manages investigational Product (IP) and trial materials. This individual will conduct regular site visits, prepare final reports and liaises with interested parties regarding all trial aspects. The successful candidate will act as Aquestive Therapeutics' representative by conducting said activities directly, or by overseeing, verifying, and/or monitoring those activities conducted by CRO contracted CRAs. The CRA will ensure that study execution is performed in line with the Code of Federal Regulations (CRF) of the Food and Drug Administration (FDA) and the International Conference of Harmonization - Good Clinical Practice (ICH-GCP).

Job Responsibilities:

• Prepares and independently performs study site qualification, initiation, interim monitoring, and close-out visits at the clinical investigative sites to ensure adherence to protocol, procedures, and project plans in accordance with FDA regulations.

• Obtains and prepares regulatory/essential documents throughout the duration of a study including, but not limited to, FDA 1572, CVs, professional licensure, financial disclosure forms and IRB submission forms, etc.

• Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement.

• Completes monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, and deficiencies.

• Monitors clinical trials activities at the site-level, following established standard operating procedures (SOPs), good clinical practices (GCPs) and regulatory

• Ensures proper maintenance of site files, trial master files and study documentation.

• Supports the operational execution of clinical trial procedures, ensuring high quality, accuracy and integrity of data reported.

• In conjunction with other clinical operations team members, manages the study conduct of assigned clinical sites and studies, including acting as liaison to clinical investigators, ensuring the quality and integrity of data.

• Ensures proactive risk identification and mitigation planning for assigned clinical trial

• Assists investigators and staff to resolve issues quickly and

• Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to site requests, and documents all pertinent

• At the investigation site, tracks clinical trial supplies, patient recruitment activities, and Serious Adverse Events (SAEs), reviews Case Report Forms (CRFs) for accuracy and completeness and conducts query resolution.

• Assists in identifying investigator sites for participation in

• May attend procedures involving study participants to support study protocol data

• Assists in the review of protocols, informed consent and case report forms.

• Participates as needed in planning and conduct of Investigator meetings, including giving presentations to peers and study site personnel.

• Assists in developing Monitoring plans, Assists in the maintenance of Trial Master File (TMF).

• Assists in the collection and maintenance of study data and collateral materials for reports to senior management and regulatory authorities. This may include reviewing clinical documents and reports, reviewing data listings, participating in the completion of medical writing assignments and performing quality control reviews.

• Assists in developing monitoring guidelines and other assorted project-specific resources and training materials.

Job Qualifications:

• A college degree is required (i.e., RN, BS in relevant medical field), Bachelor's degree in science/health-care field, or an equivalent combination of education.

• Minimum 3 years of clinical monitoring experience; must also demonstrate solid working knowledge of ICH, GCP, and

• Ability to travel 1-2 days a week to Aquestive office in Warren NJ

• Excellent written and oral communication

• Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.

• Excellent interpersonal skills, great understanding of team-

• Detail-oriented, have the ability to multitask and be able to collaborate with various role

• Demonstrate a nature of proactivity, enthusiasm, independent drive, and energetic outlook to tasks.

• Exceptional organizational Ability to manage and prioritize workload effectively.

• Ability to collaborate, build strong partnerships/relationships with all stakeholders.

• Ability to travel by plane up to 50%.

• Must maintain a valid driver's license and the ability to drive to monitoring site.

• Available to travel extensively and on short notice, and ability to manage travel

• Must be detail-oriented and efficient in time management.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.