Clinical Research Associate

1 week ago

Boston, United States Alira Health Group Full time
In-House Clinical Research Associate

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

At Alira Health, our mission is to enable healthcare transformation. Our team collaborates fully to understand every aspect of each client’s organization from concept ideation to commercial realization; from innovation to implementation. We support our clients with a full spectrum of patient-centric data and tech-enabled services.

The In-house Clinical Research Associate (CRA) is an important member of the Alira Health Clinical team. In-house CRAs manage and support clinical sites from site approval through close-out. In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel.

Essential Job Functions

  • Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc.
  • Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs.
  • Responds to sites’ regulatory board requests for protocol and ICF clarification as needed.
  • Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment.
  • Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews.
  • Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites.
  • Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests.
  • Conducts remote review of data entered on electronic Case Report Forms (eCRFs).
  • Works closely with field CRAs and data management to resolve queries on discrepant data.
  • Assists with efforts to recruit investigative sites to participate in clinical studies.
  • Complies with ICH GCP guidelines, FDA regulations, and company SOPs.
  • Participates in internal, client/sponsor, scientific, and other meetings as required.
  • Manages and resolves conflicting priorities to deliver on commitments.
  • Performs additional duties as assigned.

Preparation, Knowledge, Skills & Abilities

  • BS/BA from an undergraduate program or equivalent experience.
  • 1-2 years of experience in clinical research.
  • 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.
  • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills.
  • 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 U.S.

Working Conditions/Physical Demands

  • Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs.

Languages

English

Education

Bachelor of Arts (BA), Bachelor of Science (BS)

Contract Type

Regular

About Us

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance.

Why Work at Alira Health?

With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more.

Join Our Team

We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities.

#J-18808-Ljbffr

  • Clinical Research Associate

    4 weeks ago

    Boston, United States ALKU Full time

    Clinical Research Associate (IVD)Background: The client is a mid-sized medical device diagnostic company that focuses on laboratory equipment. They are in need of a Clinical Research Associate that will be in charge of site management for multiple sites focusing on IVD equipment. They will be tasked with overseeing this site from study start up to close out...

  • Clinical Research Associate

    4 weeks ago

    boston, United States ALKU Full time

    Clinical Research Associate (IVD)Background: The client is a mid-sized medical device diagnostic company that focuses on laboratory equipment. They are in need of a Clinical Research Associate that will be in charge of site management for multiple sites focusing on IVD equipment. They will be tasked with overseeing this site from study start up to close out...

  • Clinical Research Associate

    4 weeks ago

    Boston, United States ALKU Full time

    Clinical Research Associate (IVD)Background: The client is a mid-sized medical device diagnostic company that focuses on laboratory equipment. They are in need of a Clinical Research Associate that will be in charge of site management for multiple sites focusing on IVD equipment. They will be tasked with overseeing this site from study start up to close out...

  • Clinical Research Associate

    6 months ago

    Boston, United States Massachusetts General Hospital Full time

    Clinical Research Associate-(3292572) Description The Clinical Research Associate (CRA) will assist with our study on Mindful Self-Compassion as a treatment for PTSD. The CRA will deliver the study intervention to participants. This study is conducted online over Zoom, and the position is remote.  As a not-for-profit organization, Mass General...

  • Sr. Clinical Research Associate

    2 days ago

    Boston, MA, United States Real Staffing Group Full time

    Title: Seeking a Sr. Clinical Research Associate for Exciting Remote Opportunity on the East CoastIntroductory Paragraph:Our client, a leading pharmaceutical company, is seeking an experienced Senior Clinical Research Associate (CRA) to join their team remotely on the East Coast. As a CRA with this innovative and growing organization, you will play a...

  • Clinical Research Associate---Cancer Center Protocol Office

    6 months ago

    Boston, United States Massachusetts General Hospital Full time

    Clinical Research Associate---Cancer Center Protocol Office-(3291035) Description GENERAL SUMMARY/ OVERVIEW STATEMENT: The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate. The Cancer Center Protocol Office is a centralized research office that supports clinical...

  • Associate/Research Associate in Microbiology

    22 hours ago

    Boston, United States Harvard University Full time

    Associate/Research Associate in Microbiology Title: Associate/Research Associate in Microbiology School: Harvard School of Dental Medicine Department/Area: Oral Medicine, Infection, and Immunity Position Description: Under direction of the Principal Investigator and Senior Research Associate, the Associate/Research Associate in Microbiology will provide...

  • Clinical Research Specialist

    7 days ago

    Boston, Massachusetts, United States Lifelancer Full time

    About Private Health ManagementPrivate Health Management is a clinically sophisticated complex care management company, specializing in assisting clients to obtain the best care and outcomes when facing serious and complex medical conditions.We consistently deliver better care and outcomes helping people live healthier, longer lives.About the RoleThe...

  • Assistant/Associate Editor, Molecular Cancer Research

    1 month ago

    Boston, United States American Association for Cancer Research Full time

    Overview: Position Summary: The AACR has an exciting opportunity for an individual passionate about the advancement of cancer science to join the editorial team of Molecular Cancer Research as Assistant or Associate Editor, based on experience level. The Assistant/Associate Editor, Molecular Cancer Research, will report to the Editorial Director and will...

  • Assistant/Associate Editor, Molecular Cancer Research

    2 weeks ago

    Boston, United States American Association for Cancer Research Full time

    Overview: Position Summary: The AACR has an exciting opportunity for an individual passionate about the advancement of cancer science to join the editorial team of Molecular Cancer Research as Assistant or Associate Editor, based on experience level. The Assistant/Associate Editor, Molecular Cancer Research, will report to the Editorial Director and will...

  • Dietetic Research Associate Position

    2 weeks ago

    Boston, Massachusetts, United States Mass General Brigham Full time

    Job SummaryThe Mass General Brigham team is seeking a highly skilled Dietetic Research Associate to support research studies on the Translational & Clinical Research Centers.

  • Clinical Research Nurse

    3 weeks ago

    Boston, United States Tufts University Full time

    Overview This is a part-time position at 21 hours per week and has a prorated salary. The prorated salary is Minimum $42,630 - Midpoint $53,310 - Maximum $64,020. This position is grant funded and is not eligible for severance pay. The mission of the Jean Mayer USDA-Human Nutrition Research Center on Aging (HNRCA) at Tufts is to promote healthy aging...

  • Clinical Research Nurse

    1 month ago

    Boston, United States Tufts University Full time

    Job DescriptionOverviewThis is a part-time position at 21 hours per week and has a prorated salary. The prorated salary is Minimum $42,630 - Midpoint $53,310 - Maximum $64,020. This position is grant funded and is not eligible for severance pay. The mission of the Jean Mayer USDA-Human Nutrition Research Center on Aging (HNRCA) at Tufts is to promote healthy...

  • Clinical Research Nurse

    4 weeks ago

    Boston, United States Tufts University Full time

    Job DescriptionOverviewThis is a part-time position at 21 hours per week and has a prorated salary. The prorated salary is Minimum $42,630 - Midpoint $53,310 - Maximum $64,020. This position is grant funded and is not eligible for severance pay. The mission of the Jean Mayer USDA-Human Nutrition Research Center on Aging (HNRCA) at Tufts is to promote healthy...

  • Clinical Research Associate II Cancer Center Protocol Office

    2 weeks ago

    Boston, United States Mass General Brigham Full time

    Description: GENERAL SUMMARY/ OVERVIEW STATEMENT: The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking Clinical Research Associate (CRA)...

  • Clinical Research Associate II Cancer Center Protocol Office

    2 weeks ago

    Boston, United States Mass General Brigham Full time

    Description: GENERAL SUMMARY/ OVERVIEW STATEMENT: The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking Clinical Research Associate (CRA)...

  • Associate Chief of Gastroenterology for Research

    2 months ago

    Boston, United States Tufts Medical Center Full time

    The Division of Gastroenterology in the Department of Medicine at Tufts Medical Center in Boston is seeking a full-timeGastroenterologistwith significant experience in clinical and/or translational research to lead the divisional research program as the Associate Chief of Gastroenterology for Research. We are looking for an experienced gastroenterologist who...

  • Associate Chief of Gastroenterology for Research

    2 months ago

    Boston, United States Tufts Medicine Full time

    The Division of Gastroenterology in the Department of Medicine at Tufts Medical Center in Boston is seeking a full-time Gastroenterologist with significant experience in clinical and/or translational research to lead the divisional research program as the Associate Chief of Gastroenterology for Research . We are looking for an experienced gastroenterologist...

  • Clinical Research Professional

    2 months ago

    Boston, United States UpTrials Full time

    We are looking for motivated individuals to join UpTrials, a new online platform that makes it easier and faster to find clinical research jobs. Roles on our website support the coordination and management of clinical research activities and involve working closely with research teams to oversee daily study operations and ensure compliance with all...

  • Associate Chief of Gastroenterology for Research

    3 weeks ago

    Boston, United States Tufts Medicine Full time

    We’re saving lives, building careers, and reimagining healthcare. We can’t wait to grow alongside you. The Division of Gastroenterology in the Department of Medicine at Tufts Medical Center in Boston is seeking a full-time Gastroenterologist with significant experience in clinical and/or translational research to lead the divisional research program as...