Clinical Research Associate (ADX-186-20)

| Greater Boulder Area
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Clinical Research Associate (ADX-186-20)
 
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THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com

 

ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 

 
POSITION SUMMARY: 
 
ArcherDX has an opening for a Clinical Research Associate to join the Clinical Development and Operations team. Responsible for the conduct of clinical study activities to verify and validate new assays developed by ArcherDX. Works closely with study managers and other CRA staff to complete all CRA functions associated with study planning, implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).
 
May travel up to 30% domestically and internationally
*will follow CDC and ArcherDX travel restrictions.
 
RESPONSIBILITIES:
 
Site Management & Monitoring:
  • Conducts in-house monitoring, ability to independently perform on-site monitoring in accordance with ArcherDX Standard Operating Procedures, ICH GCP guidelines and Regulations.
  • Communicates on behalf of the study manager with investigators and site staff.
  • Maintain regular communication with CRO staff, following up on protocol deviations to resolution
  • Prepares study visit reports
  • Primary responsibility to coordinate shipping and tracking of clinical trial supplies at ArcherDX for the CRO sites
  • Assist with site-level IRB submissions, queries and documentation 
  • Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures
  • Safeguarding the privacy and security of protected health information and European Union personal data
  • Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology
Study Implementation:
Assists in preparation and independent execution of:
  • Study training presentations for investigators and site staff.
  • Study supply ordering and shipping.
  • Investigational product release, labeling, accountability at study sites.
  • Site Readiness and Site Monitoring Plans.
  • Assay transfer and operator training and qualification activities.
  • Study records including site and trial master files.
  • Site qualification, site initiation, routine monitoring and close out visits and reports.
  • Document compilation for clinical study reports and document archive activities.
  • Data management activities including user acceptance testing, data entry, and data verification as needed.
Departmental Roles:
  • Works within project teams to facilitate the conduct of standard study designs.
  • Participates in clinical operations meetings and completes independent activities to support departmental functions.
  • Completes all internal training programs in a timely manner, and demonstrates professional development via independent reading, networking and training.
EXPERIENCE:
  • Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) preferred.
  • Required 2+ years of previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or clinical study management experience
  • Thorough knowledge of ICH/GCP guidelines is required
  • Background in biomedical/ healthcare services with laboratory experience preferred
  • Clinical research certification (CCRA, ACRP or equivalent) is preferred
  • Experience with IVD clinical studies is a plus
  • Experience working with Contract Research Labs is a plus
  • Excellent organization skills and attention to detail
  • Ability to work independently in a fast paced and dynamic environment
  • Ability to work cooperatively as a contributing team member, with individuals from diverse backgrounds
  • Strong oral and written communication skills
  • Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
  • Experience with eTMF systems is a plus
EDUCATION:
  • Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience.
KNOWLEDGE, SKILLS AND ABILITIES:
  • Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint).
  • Excellent writing and verbal communication skills.
  • Well organized and detail oriented.
  • Impeccable record keeping and filing skills.
  • Excellent time management skills.
  • Ability to give presentations and teach others.
  • Ability to work effectively in a team, and also work independently on assigned tasks
 
 
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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!

Ali

Director, Global Marketing

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Employees who have been with the company for 12 months are eligible for 12 weeks of family medical leave.
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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