Clinical Research Associate Job at Alira Health, Framingham, MA

Ty9VVzRBQU11QXRrYnRqWUdYZGZUbzJkOXc9PQ==
  • Alira Health
  • Framingham, MA

Job Description

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
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences

Contract Type
Regular

Job Tags

Permanent employment, Contract work, Interim role,

Similar Jobs

Radtke Physical Therapy

Licensed Physical Therapist Job at Radtke Physical Therapy

 ...Job Description Company Description RadtkePhysical Therapyis an outpatient physical therapy and rehabilitation practice that specializes in orthopedic and sports injuries. We are dedicated to providing the highest quality of care in a friendly and encouraging... 

University of Minnesota

Political Psychology Graduate Research Assistant Job at University of Minnesota

 ...ID371531 LocationDuluth Job FamilyGraduate Assistants Full/Part TimePart-Time Regular/TemporaryRegular...  ...Jobs Email this Job About the Job The UMD Psychology Department will be hiring a 25% (10 hours per week) Graduate Research Assistant to support research with... 

Encore Technologies

Customer Success Manager (Cincinnati) Job at Encore Technologies

 ...Position Summary As a Customer Success Manager at Encore, you will play a pivotal role, working closely with Account teams, Clients, Service...  ...pushing, pulling up to 15 lbs. Hybrid position in office and remote workdays Encore Technolgies is an Equal Opportunity... 

Texas Roadhouse

Line Cook Job at Texas Roadhouse

 ...Job Description At Texas Roadhouse, we are a people-first company that just happens to serve steaks. Legendary Food and Legendary Service is who we are. Were about loving what youre doing today and preparing you for what youll be doing tomorrow. Are you ready to... 

Shawna Kolles State Farm

Insurance Sales Representative Job at Shawna Kolles State Farm

 ...Job Description Job Description At Shawna Kolles State Farm, we are committed to providing exceptional insurance solutions tailored to our clients needs. We pride ourselves on integrity, customer service, and a collaborative work environment. We are seeking a motivated...