Lead Clinical Research Associate (100% Remote)
Company: Jobot
Location: Nashville
Posted on: January 16, 2022
|
|
|
Job Description:
100 % REMOTE
This Jobot Job is hosted by Juan Correa
Are you a fit? Easy Apply now by clicking the "Apply" button and
sending us your resume.
Salary $95,000 - $120,000 per year
A Bit About Us
We are a clinical-stage biopharmaceutical company that discovers,
develops and seeks to commercialize next-generation therapeutics
for diseases representing significant unmet medical needs and
burden to society, patients, and their families. Our current
pipeline focuses on the central nervous system, respiratory, and
metabolic diseases.
Why join us?
Job Details
Job Description
The Lead Clinical Research Associate is responsible for the
delivery of all clinical aspects of clinical studies. The Lead CRA
provides operational expertise, and to ensure the effective and
efficient delivery of all aspects of multiple studies, through all
phases of clinical study management, in accordance with Standard
Operating Procedures (SOPs), current Good Clinical Practice (GCP),
International Conference on Harmonization (ICH), and applicable
local regulation.
Essential Duties And Responsibilities
Contribute to all clinical research activities to ensure successful
management of clinical studies.
Maintain and track clinical study data and support in investigator
qualification and selection, analysis of potential patient
recruitment, and overall study status/progress throughout the life
of a study.
Manage site start-up/activation process, including
Heavy contribution to the preparation of study related documents
(protocols, case report forms (CRFs) or eCRFs, draft informed
consent forms (ICF) and complete checklists, able to support in
clinical trial agreements and budget negotiation, clinical
monitoring plan),
Organizing IRB/EC submissions and applicable regulatory
documentation with follow through to ensure successful
outcomes.
Perform on-site and remote site qualification visits, site
initiation visits, interim monitoring visits and site close out
visits
Conduct clinical study monitoring to ensure regulatory and protocol
compliance as well as overall data accuracy in accordance with the
study clinical monitoring plan.
Complete source data verification of clinical study data entered in
an Electronic Data Capture (EDC) system or on a case report form at
sites to ensure regulatory and protocol compliance and overall
accuracy.
Serve as main liaison to participating clinical trial sites with
focus on data entry, query resolution, investigational device
tracking and accountability, and study conduct oversight at the
participating clinical sites.
Collaborate with data management to support data cleaning
process
Lead review of safety events and collaborate on development of
narrative and reporting as needed
Develop and manage study trial master file and maintain study
documentation and clinical trial management system (e.g.,
correspondence, CRFs, study approval documents), trip reports, site
contact documentation, monthly status reports (e.g., enrollment,
adverse events, budget, etc.)
Track, process and manage site payments and support in study
financial tracking by developing tracking tools as necessary.
Assist Clinical Study Manager/Director on study scoping activities,
including but not limited to development of pre-study
questionnaires, study design and site selection
Support site audits and site audit preparation in anticipation of
site inspections
Job Requirements
Life sciences bachelor's degree or certification in a related
allied health profession from an accredited institution (e.g.,
nursing, medical or laboratory technology) or equivalent
Clinical research/clinical trial management certification/education
preferred
Minimum 5 years of experience in clinical trial operations and
monitoring required, experience with CNS clinical trials strongly
preferred; neuropsychiatry/schizophrenia recommended; clinical
audit experience also recommended
Experience Working With Electronic Data Capture (EDC) Systems
Required
Possess advanced knowledge of Clinical investigation of medical
devices for human subjects - Good Clinical Practice (ISO 14155), 21
CFR Part 11, 50, 54, 812 and other applicable regulations
Must be clinically savvy and possess time management,
organizational skills and problem-solving skills.
Excellent written and oral communication skills and interpersonal
skills with high attention to detail
Ability to work successfully in a team environment and ability to
prioritize and manage multiple tasks as necessary.
Proficiency in Microsoft Office Suite, PDF application
Experience Working With Electronic Data Capture (EDC) Systems
Required
Available to travel if/when needed
Interested in hearing more? Easy Apply now by clicking the "Apply"
button.
Keywords: Jobot, Nashville , Lead Clinical Research Associate (100% Remote), Healthcare , Nashville, Tennessee
|
Click
here to apply!
|
