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IQVIA
Clinical Research Associate, Sponsor Dedicated
Source: National Labor Exchange
IQVIA
Clinical Research Associate, Sponsor Dedicated
Source: National Labor Exchange
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Clinical Research Associate, Sponsor Dedicated
Source: National Labor Exchange
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Job ID #84467
IQVIA
Clinical Research Associate, Sponsor Dedicated
location_on
Clinton, MO
description
Summary
Durham, North Carolina, United States of America
Aurora, Illinois, United States
San Fernando, California, United States
Clinton, Missouri, United States
Mansfield, Ohio, United States
Santa Cruz, California, United States
Santa Fe, New Mexico, United States
South Shore, Illinois, United States
Elk Grove, California, United States
Hudson, Ohio, United States
Englewood, Colorado, United States
Bellingham, Washington, United States
Marysville, Washington, United States
Overland Park, KS, United States of America
Evanston, Wyoming, United States
La Habra, California, United States
Prescott, Arizona, United States
Westchester, New York, United States
Mount Vernon, Illinois, United States
Warren, Ohio, United States of America
Linden, New Jersey, United States
Fremont, California, United States
Del Mar, California, United States
Lake Tahoe, California, United States
Northfield, New Jersey, United States
Fort Pierce, Florida, United States
Wilkes Barre, Pennsylvania, United States
Camden, New Jersey, United States
Lancaster, California, United States
Clarksville, Tennessee, United States
Adair, Iowa, United States
Fort Collins, Colorado, United States
Breckenridge, Colorado, United States
Littleton, Colorado, United States
Liverpool, New York, United States
Ft Lauderdale, Florida, United States
Springfield, Ohio, United States
Long Island, New York, United States
Gloucester, Virginia, United States
West Point, Virginia, United States
O'Fallon, Illinois, United States
Cheyenne, Wyoming, United States
Manhattan, New York, United States
New City, New York, United States
Parsippany, New Jersey, United States of America
Queens, New York, United States
New York City, New York, United States
Escondido, California, United States
Oak Brook, Illinois, United States
Merritt Island, Florida, United States
El Cajon, California, United States
Ontario, California, United States
Afton, Wyoming, United States
Abilene, Texas, United States
Orangevale, California, United States
Abingdon, Virginia, United States
Orland Park, Illinois, United States
Shenandoah, Texas, United States
Akron, Ohio, United States
Paradise Valley, Arizona, United States
Newark, Delaware, United States
Hollywood, Florida, United States
Port Saint Lucie, Florida, United States
Lawton, Oklahoma, United States
Portland, Oregon, United States
Chino Hills, California, United States
Belmar, New Jersey, United States
Sonora, California, United States
Berkley, California, United States
Springfield, Massachusetts, United States
Springfield, Missouri, United States
San Jose, California, United States
Beverly Hills, California, United States
Melbourne, Florida, United States
Colorado Springs, Colorado, United States
St. Petersburg, Florida, United States
Panama City, Florida, United States
Redondo Beach, California, United States
Crystal Lake, Illinois, United States
Rochester, New York, United States
Ada, Oklahoma, United States
Kansas City, Missouri, United States
Ainsworth, Nebraska, United States
Carlsbad, CA, United States of America
Denver , Colorado, United States
Full time
R1573488
To be eligible for this position, you must reside in the same country where the job is located.
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least 2 years of year of independent on-site monitoring experience as a Clinical Research Associate (CRA) in a CRO, sponsor, or similar setting.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Must have experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems in support of monitoring activities.
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population healt...
Aurora, Illinois, United States
San Fernando, California, United States
Clinton, Missouri, United States
Mansfield, Ohio, United States
Santa Cruz, California, United States
Santa Fe, New Mexico, United States
South Shore, Illinois, United States
Elk Grove, California, United States
Hudson, Ohio, United States
Englewood, Colorado, United States
Bellingham, Washington, United States
Marysville, Washington, United States
Overland Park, KS, United States of America
Evanston, Wyoming, United States
La Habra, California, United States
Prescott, Arizona, United States
Westchester, New York, United States
Mount Vernon, Illinois, United States
Warren, Ohio, United States of America
Linden, New Jersey, United States
Fremont, California, United States
Del Mar, California, United States
Lake Tahoe, California, United States
Northfield, New Jersey, United States
Fort Pierce, Florida, United States
Wilkes Barre, Pennsylvania, United States
Camden, New Jersey, United States
Lancaster, California, United States
Clarksville, Tennessee, United States
Adair, Iowa, United States
Fort Collins, Colorado, United States
Breckenridge, Colorado, United States
Littleton, Colorado, United States
Liverpool, New York, United States
Ft Lauderdale, Florida, United States
Springfield, Ohio, United States
Long Island, New York, United States
Gloucester, Virginia, United States
West Point, Virginia, United States
O'Fallon, Illinois, United States
Cheyenne, Wyoming, United States
Manhattan, New York, United States
New City, New York, United States
Parsippany, New Jersey, United States of America
Queens, New York, United States
New York City, New York, United States
Escondido, California, United States
Oak Brook, Illinois, United States
Merritt Island, Florida, United States
El Cajon, California, United States
Ontario, California, United States
Afton, Wyoming, United States
Abilene, Texas, United States
Orangevale, California, United States
Abingdon, Virginia, United States
Orland Park, Illinois, United States
Shenandoah, Texas, United States
Akron, Ohio, United States
Paradise Valley, Arizona, United States
Newark, Delaware, United States
Hollywood, Florida, United States
Port Saint Lucie, Florida, United States
Lawton, Oklahoma, United States
Portland, Oregon, United States
Chino Hills, California, United States
Belmar, New Jersey, United States
Sonora, California, United States
Berkley, California, United States
Springfield, Massachusetts, United States
Springfield, Missouri, United States
San Jose, California, United States
Beverly Hills, California, United States
Melbourne, Florida, United States
Colorado Springs, Colorado, United States
St. Petersburg, Florida, United States
Panama City, Florida, United States
Redondo Beach, California, United States
Crystal Lake, Illinois, United States
Rochester, New York, United States
Ada, Oklahoma, United States
Kansas City, Missouri, United States
Ainsworth, Nebraska, United States
Carlsbad, CA, United States of America
Denver , Colorado, United States
Full time
R1573488
To be eligible for this position, you must reside in the same country where the job is located.
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least 2 years of year of independent on-site monitoring experience as a Clinical Research Associate (CRA) in a CRO, sponsor, or similar setting.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Must have experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems in support of monitoring activities.
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population healt...
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