Clinical Research Associate (ADX-186-20)
| Greater Boulder Area
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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