Job Description

Job Description

Job Description

Job Description:

We are seeking a highly motivated and qualified individual to join our Clinical Department as an in-house CRA 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 in-house CRA (CRA) is responsible under supervision for supporting the administration and progress of clinical trial(s) on behalf of ADARx Pharmaceuticals. The CRA monitors the research procedures and ensures that research is always following the proper clinical trial protocol to obtain the correct data.

The CRA also ensures that these processes are performed in line with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP).

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 tracking).
• Assure regulatory compliance of investigational sites with ADARx Pharmaceuticals SOPs, FDA regulations, and ICH guidelines.
• Review and approve monitoring visit reports.
• Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
• Collect completed CRFs and other trial materials throughout and at the end of the study.
• Maintain internal document management system and TMF ensuring important documents and communication filed timely and appropriately.
• Assist and support data query process.
• Verify internal data listings.
• Generate reports or notes to files, and file/collate trial documentation and reports.
• 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 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 protocol development and study report completion.
• 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.
• May include monitoring the trial throughout its duration for specific tasks or activities.
• Coordinate study supplies at all sites.
• Assist with preparing final reports.
• Archive study documentation and correspondence as appropriate.
• Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience.
• Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
• Maintain all corporate standards for lab safety and hazardous material management.
• 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 or ADN.
• Minimum 4 years of relevant clinical research experience.
• Clinical research related monitoring or study coordinator experience.
• Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
• Proficiency working with Microsoft Office Suite Products.
• Ability to travel (domestic/international) if necessary.

Preferred Qualifications:

• Global clinical trial experience preferred.
• Clinical research or life sciences degree preferred.

Required Key Attributes:

• Must be able to work independently with supervision as needed.
• Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
• Strong problem-solving skills and a proactive attitude towards exploring new approaches.
• Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
• 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.

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:

ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system.

ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms.

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.

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