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Jobs at ADARx Pharmaceuticals Inc. (Now Hiring) — 4 open

ADARx Pharmaceuticals Inc. logoADARx Pharmaceuticals Inc.

Sr. Clinical Trial Assistant

San Diego, California, United States · On-site

$85k–$120k/yr

Senior$332M raised

Job Description: We are seeking a highly motivated and detail orientated individual to join our Clinical Department as a Sr. Clinical Trial Assistant and work as part of a team to drive success. The Sr. CTA will support …

Skills: Clinical Trial Administration, GCP Compliance, ICH Guidelines, FDA Regulations, TMF Tracking

ADARx Pharmaceuticals Inc. logoADARx Pharmaceuticals Inc.

Sr. Accounts Payable Specialist

San Diego, California, United States · On-site

$71k–$82k/yr

Mid level$332M raised

ADARx Pharmaceuticals is seeking a detail-oriented and highly organized Senior Accounts Payable Specialist to join our Finance Department. This role will support and help oversee the full-cycle accounts payable process a…

Skills: Full-cycle Accounts Payable, Vendor Management, Month-end Close, Account Reconciliation, Journal Entries

ADARx Pharmaceuticals Inc. logoADARx Pharmaceuticals Inc.

Sr. Clinical Trial Assistant

San Diego, California, United States · On-site

$85k–$120k/yr

Senior$332M raised

Job Description: We are seeking a highly motivated and detail orientated individual to join our Clinical Department as a Sr. Clinical Trial Assistant and work as part of a team to drive success. The Sr. CTA will support …

Skills: Clinical Trial Administration, GCP Compliance, ICH Guidelines, FDA Regulations, TMF Management

ADARx Pharmaceuticals Inc. logoADARx Pharmaceuticals Inc.

Senior Research Associate, Discovery Biology

San Diego, California, United States · On-site

$75k–$85k/yr

Senior$332M raised

We are seeking a motivated and organized Senior Research Associate who aspires to make a meaningful impact on patients’ lives across multiple therapeutic areas. This is an exciting opportunity to join our Discovery…

Skills: In vivo studies, qPCR, ELISA, Western blotting, Molecular biology

ADARx Pharmaceuticals Inc. logo

Sr. Clinical Trial Assistant

ADARx Pharmaceuticals Inc.

San Diego, California, United States • On-site

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Senior

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  • $85k–$120k/yr
  • Full-time
  • bachelor degree, postgraduate degree
  • Medical Insurance, Vision Insurance, Dental Insurance, Life Insurance, 401(k) Matching Program, Paid Time Off
  • Posted 10d ago
  • ~40 hrs/week

Responsibilities

The Sr. CTA supports all phases of clinical study activities, focusing on operational aspects, regulatory compliance, and study start-up. Key duties include managing study supplies, tracking patient enrollment, and maintaining the Trial Master File (TMF).

Requirements

Requires a BS/MS in life or health sciences and at least 5 years of experience in clinical trial administration. Candidates must have deep knowledge of GCP, ICH, and FDA regulations, along with experience in global Phase I-IV trials.

Full job description

Job Description:

We are seeking a highly motivated and detail orientated individual to join our Clinical Department as a Sr. Clinical Trial Assistant and work as part of a team to drive success. The Sr. CTA will support all phases of clinical study activities under the direction and supervisor of the ADARx Clinical Operations Lead(s). The CTA 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:

  • Develop and promote a workplace culture that values diversity of thought, promote integrity and create an atmosphere that supports coaching and fosters accountability.
  • Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner.
  • Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
  • 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). 
  • Ensure adherence to Good Clinical Practice (GCP) and regulatory guidelines throughout the trial lifecycle.
  • Coordinates oversight of the study supplies at all sites, manage study logistics, including site selection, initiation, monitoring, and close-out activities.
  • Track progress against project timelines, generate regular status updates, and communicate progress and issues to management.
  • Track patient enrollment and recommend solutions to increase appropriate enrollment of qualified subjects. 
  • Assist in the development and maintenance of clinical trial documentation, including study protocols, informed consent forms, and regulatory submissions.
  • Conduct site visits and liaise with clinical site staff to ensure proper study conduct and data integrity as required.
  • Assist with preparing training materials used to train site staff during the SIV and at other times to trial-specific industry standards. 
  • Generate reports or notes to files, and file/collate trial documentation and reports. 
  • 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 
  • 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 planning and participating in investigator meetings. 
  • 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 
  • Reviews and recommend updates for departmental SOPs, may draft updates to SOPs depending on experience and level.
  • Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience.
  • Train and mentor entry-level staff.
  • Maintain all appropriate corporate standards for facility 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:

  • BS/MS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent). 
  • 5+ years of experience in clinical trial administration, with a deep understanding of the clinical trial process and regulatory requirements.
  • Global clinical trial experience; Familiarity with clinical trial design and methodology, including Phase I-IV trials.
  • Proven experience in managing multiple clinical trials simultaneously while maintaining high attention to detail.
  • Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
  • Experience with clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS), including report generation.
  • Excellent organizational, written and verbal communication skills; and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
  • Proficiency working with Microsoft Office Suite Products.
  • Ability to work across global time zones (including EU, APAC). 
  • Willingness to work occasional weekends based on study needs.
  • Ability to travel (domestic/international), if necessary.

Required Key Attributes:

  • Must be able to work independently with supervision as needed.
  • Proficient at working independently as well as in cross-functional team settings
  • 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.
  • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.

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 dedicated to transforming cutting-edge science into next-generation RNA therapeutics to treat a broad spectrum of diseases. 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.

Related keywords

Clinical TrialsGCPICH-GCPCFRTMFeTMFEDCCTMSIWRSPhase I-IVSOPInformed Consent FormsRegulatory SubmissionsSite Initiation VisitSource Data VerificationRNA Therapeutics

About ADARx Pharmaceuticals Inc.

LinkedInVisit site

Our vision is to provide effective and safe RNA therapeutics to patients who suffer from intractable diseases.

Industry
Biotechnology Research
Company size
51-200 employees
Founded
2019
Headquarters
San Diego, CA
LinkedIn followers
15,137
Total funding
$332M

ADARx Pharmaceuticals, Inc., 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 oligonucleotide delivery technologies for inhibition, degradation, and editing disease-causing 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 diseases.  We are well-financed by a syndicate of renowned VC firms. ADARx currently has multiple active programs in development. Our lead candidate is at the clinical stage.

Offices: 5871 Oberlin Drive, San Diego, CA 92121, US

Health CareBiotechnologyMedicalPharmaceutical
View all jobs at ADARx Pharmaceuticals Inc.

About ADARx Pharmaceuticals Inc.

LinkedInVisit site

Our vision is to provide effective and safe RNA therapeutics to patients who suffer from intractable diseases.

Industry
Biotechnology Research
Company size
51-200 employees
Founded
2019
Headquarters
San Diego, CA
LinkedIn followers
15,137
Total funding
$332M

ADARx Pharmaceuticals, Inc., 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 oligonucleotide delivery technologies for inhibition, degradation, and editing disease-causing 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 diseases.  We are well-financed by a syndicate of renowned VC firms. ADARx currently has multiple active programs in development. Our lead candidate is at the clinical stage.

Offices: 5871 Oberlin Drive, San Diego, CA 92121, US

Health CareBiotechnologyMedicalPharmaceutical
View all jobs at ADARx Pharmaceuticals Inc.

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