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Clinical Research Associate
Alira Health San Francisco, CA
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$79k-104k (estimate)
Full Time Just Posted
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Alira Health is Hiring a Clinical Research Associate Near San Francisco, CA

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

The Clinical Research Associate is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

KEY RESPONSABILITIES

* Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits.

* Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.

* Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.

* Ensures integrity of CRF data through meticulous and thorough source document review and verification.

* Conducts investigational product accountability.

* Reviews regulatory binder for required documents.

* Works closely with in-house CRAs and data management to resolve queries on discrepant data.

* Proactively identifies site issues and develops problem-solving strategies for sites.

* Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.

* Conducts audit preparation at study sites as needed.

* Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.

* Manages and resolves conflicting priorities to deliver on commitments.

* Complies with ICH GCP guidelines, FDA regulations, and company SOPs.

* Participates in industry and client meetings.

* Performs additional duties as assigned.

DESIRED QUALIFICATION & EXPERIENCE

* BS/BA from an undergraduate program or equivalent experience

* 2 years of clinical research experience

TECHNICAL COMPETENCES & SOFT SKILLS

* Ability to travel.

* Proven ability to be careful, thorough, and detail-oriented.

* Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment.

* Self-starter who thrives in a collaborative, yet less structured team environment

* Ability to problem-solve unstructured or ambiguous challenges.

* Strong command of English, both written and verbal.

* Excellent communication and interpersonal skills with customer service orientation.

* Proficient with MS Office Suite, particularly Word and Excel.

* Permanent authorization to work in the country where you are applying.

Languages

English

Education

Job Summary

JOB TYPE

Full Time

SALARY

$79k-104k (estimate)

POST DATE

04/29/2024

EXPIRATION DATE

05/12/2024

WEBSITE

alirahealth.com

HEADQUARTERS

FRAMINGHAM, MA

SIZE

200 - 500

FOUNDED

1999

TYPE

Private

REVENUE

$10M - $50M

INDUSTRY

Business Services

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About Alira Health

Alira Health is a Massachusetts-based advisory firm that provides services such as product development and management consulting for the healthcare and life science sectors.

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The following is the career advancement route for Clinical Research Associate positions, which can be used as a reference in future career path planning. As a Clinical Research Associate, it can be promoted into senior positions as a Scientist - Clinical Research that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Associate. You can explore the career advancement for a Clinical Research Associate below and select your interested title to get hiring information.

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