Clinical Trial Research Associate

Job Description:

We are seeking a highly motivated and qualified individual to join our Clinical Operations Department as a CTRA and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The CTRA will support ongoing RNA-based drug discovery projects in several therapeutic areas.

The CTRA will support all phases of clinical study activities under the direction and supervisor of the ADARx Clinical Operations Lead(s). The CTRA will monitor and resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), Code of Federal Regulations (CFRs), International Conference of Harmonisation – Good Clinical Practice (ICH-GCP), and specific country regulations; ensuring study is conducted within clinical trial protocols.

Essential Responsibilities:

• Assist with the identification and set up of the trial sites; ensuring each site has the trial materials, including the investigational product.
• Responsible for study start- up activities and tracking study metrics (e.g. feasibility data,
• ICF review, regulatory document collection and review, and Trial Master File (TMF) tracking).
• Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
• Assist and support data query process.
• Generate reports or notes to files, and file/collate trial documentation and reports.
• Attends internal study team meetings; prepares study team agendas, responsible for taking meeting minutes and distributes study team agenda(s), meeting minutes and action items
• Assists with filing and archiving project documentation in internal document system and the eTMF within the defined timelines as well as QC reviews of CRO filings and needed follow-up
• Track patient enrollment and recommend solutions to increase appropriate enrollment of qualified subjects.
• Utilize clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS), including report generation.
• Assist with preparing and coordinating review of study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, and Informed Consents.
• Assist with coordination and be responsible for the design of study materials such as Case Report Forms (CRFs), patient diaries, study participation materials, and source documents.
• Assist with planning and participating in investigator meetings.
• Assist with preparing training materials used to train site staff during the SIV and at other times to trial-specific industry standards.
• Coordinates oversight of the study supplies at all sites.
• Archive study documentation and correspondence as appropriate.
• Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
• Maintain all appropriate corporate standards for facility safety.
• Other duties as assigned.

Essential Physical Characteristics:

Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

On-Site Protocol:

Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

Qualifications :

• BA/BS in a health-related field.
• Minimum 1-2 years of relevant clinical research and administrative experience.
• Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
• Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
• Excellent written and verbal communication skills.
• Proficiency working with Microsoft Office Suite Products.
• Ability to travel (domestic/international), if necessary.

Preferred Qualifications:

• Prior experience in biotech/pharmaceutical industry a plus.
• Global clinical trial experience a plus.

Required Key Attributes:

• Must be able to work independently as well in cross-functional team settings with supervision as needed.
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
• Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.
• Strong problem-solving skills and a proactive attitude towards exploring new approaches.

Compensation:

• This is a full-time position, Monday-Friday, occasional overtime.
• Pay is commensurate with experience.
• Equity-based compensation
• Performance-based bonuses
• 401(k) with Company Match
• Medical, Dental, Vision
• Flexible Spending Account
• Life Insurance
• Employee Assistance Program
• Employee Discounts
• Gym Membership
• Paid Vacation
• Paid Holidays
• Paid Sick, Jury Duty, Bereavement

Work Authorization:

• United States (Required)
• Background Check
• As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.

Company Overview:

We are a late-stage clinical biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a wide range of therapeutic areas. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs.

ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Disclosure Statement:

• The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
• The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
• Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
• Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.