A Senior Clinical Research Associate (Sr. CRA) is responsible for: * Conducting monitoring ... Mentoring CRAs and other Clinical Operations (CO) staff * Anticipating, recognizing and resolving ...
A Senior Clinical Research Associate (Sr. CRA) is responsible for: * Conducting monitoring ... Mentoring CRAs and other Clinical Operations (CO) staff * Anticipating, recognizing and resolving ...
Senior Clinical Research Associate
$110.52K - $138.15K/yr
Clinical Research Associate / Sr Clinical Research Associate - Oncology - Central/East region ICON ... May serve as a subject matter expert for clinical operations on monitoring related activities (Sr ...
Senior Clinical Research Associate
$110.52K - $138.15K/yr
Clinical Research Associate / Sr Clinical Research Associate - Oncology - Central/East region ICON ... May serve as a subject matter expert for clinical operations on monitoring related activities (Sr ...
Supervisor, Clinical Operations
Aurora, IL ยท On-site
$37.38 - $56.08/hr
The Supervisor, Clinical Operations provides support to organizational initiatives, serves in ... Associate's Degree in Nursing required, Bachelor's degree in Nursing preferred. For hires or ...
Supervisor, Clinical Operations
Aurora, IL ยท On-site
$37.38 - $56.08/hr
The Supervisor, Clinical Operations provides support to organizational initiatives, serves in ... Associate's Degree in Nursing required, Bachelor's degree in Nursing preferred. For hires or ...
Supervisor, Clinical Operations
Aurora, IL ยท On-site
$37.38 - $56.08/hr
The Supervisor, Clinical Operations provides support to organizational initiatives, serves in ... Associate's Degree in Nursing required, Bachelor's degree in Nursing preferred. For hires or ...
Supervisor, Clinical Operations
Aurora, IL ยท On-site
$37.38 - $56.08/hr
The Supervisor, Clinical Operations provides support to organizational initiatives, serves in ... Associate's Degree in Nursing required, Bachelor's degree in Nursing preferred. For hires or ...
Supervisor, Clinical Operations
Aurora, IL ยท On-site
$37.38 - $56.08/hr
The Supervisor, Clinical Operations provides support to organizational initiatives, serves in ... Associate's Degree in Nursing required, Bachelor's degree in Nursing preferred. For hires or ...
Supervisor, Clinical Operations
Aurora, IL ยท On-site
$37.38 - $56.08/hr
The Supervisor, Clinical Operations provides support to organizational initiatives, serves in ... Associate's Degree in Nursing required, Bachelor's degree in Nursing preferred. For hires or ...
Orthopedic Surgery Associate Medical Director
$128.28 - $192.42/hr
Orthopedic Surgery Associate Medical Director Clinical Operations Associate Medical Director Orthopedic Surgery Virtual : This role enables associates to work virtually full-time, with the exception ...
Orthopedic Surgery Associate Medical Director
$128.28 - $192.42/hr
Orthopedic Surgery Associate Medical Director Clinical Operations Associate Medical Director Orthopedic Surgery Virtual : This role enables associates to work virtually full-time, with the exception ...
... Associates at 10% effort for renewable two-year terms ... Appointees will have responsibilities in patient care and clinical operations. These positions do ...
... Associates at 10% effort for renewable two-year terms ... Appointees will have responsibilities in patient care and clinical operations. These positions do ...
... Associates at 50% effort for a renewable term of up to three years ... The appointees will have responsibilities in patient care and clinical operations. The University ...
... Associates at 50% effort for a renewable term of up to three years ... The appointees will have responsibilities in patient care and clinical operations. The University ...
Orthopedic Surgery Associate Medical Director
Chicago, IL ยท On-site
$128.28 - $192.42/hr
Clinical Operations Associate Medical Director Orthopedic Surgery Virtual: This role enables associates to work virtually full-time, with the exception of required in-person training sessions ...
Orthopedic Surgery Associate Medical Director
Chicago, IL ยท On-site
$128.28 - $192.42/hr
Clinical Operations Associate Medical Director Orthopedic Surgery Virtual: This role enables associates to work virtually full-time, with the exception of required in-person training sessions ...
Orthopedic Surgery Associate Medical Director
Chicago, IL ยท On-site
$128.28 - $192.42/hr
Clinical Operations Associate Medical Director Orthopedic Surgery Virtual : This role enables associates to work virtually full-time, with the exception of required in-person training sessions ...
Orthopedic Surgery Associate Medical Director
Chicago, IL ยท On-site
$128.28 - $192.42/hr
Clinical Operations Associate Medical Director Orthopedic Surgery Virtual : This role enables associates to work virtually full-time, with the exception of required in-person training sessions ...
Associate Medical Director - Interventional Pain
$94.06 - $153.91/hr
Associate Medical Director - Interventional Pain Clinical Operations Associate Medical Director Interventional Pain Carelon Medical Benefits Management Virtual: This role enables associates to work ...
Associate Medical Director - Interventional Pain
$94.06 - $153.91/hr
Associate Medical Director - Interventional Pain Clinical Operations Associate Medical Director Interventional Pain Carelon Medical Benefits Management Virtual: This role enables associates to work ...
Associate Medical Director - Outpatient Rehab
$188.05K - $294.91K/yr
Associate Medical Director - Outpatient Rehab Clinical Operations Associate Medical Director Carelon Medical Benefits Management Outpatient Rehab Utilization Management Review Preferred Shift: 8am ...
Associate Medical Director - Outpatient Rehab
$188.05K - $294.91K/yr
Associate Medical Director - Outpatient Rehab Clinical Operations Associate Medical Director Carelon Medical Benefits Management Outpatient Rehab Utilization Management Review Preferred Shift: 8am ...
Clinical Associate
Chicago, IL ยท On-site
$22 - $30/hr
The Clinical Associate is a vital member of our healthcare team, performing a wide range of ... Oversee laboratory operations, including specimen collection, lab orders, and processing.
Clinical Associate
Chicago, IL ยท On-site
$22 - $30/hr
The Clinical Associate is a vital member of our healthcare team, performing a wide range of ... Oversee laboratory operations, including specimen collection, lab orders, and processing.
Clinical Associate
$22 - $30/hr
The Clinical Associate is a vital member of our healthcare team, performing a wide range of ... Oversee laboratory operations, including specimen collection, lab orders, and processing.
Clinical Associate
$22 - $30/hr
The Clinical Associate is a vital member of our healthcare team, performing a wide range of ... Oversee laboratory operations, including specimen collection, lab orders, and processing.
... Associate or Full Professor for a Vice Chair position for Clinical Operations. This senior ... leadership position, reporting to the Department Chair, will work with the Department's leadership ...
... Associate or Full Professor for a Vice Chair position for Clinical Operations. This senior ... leadership position, reporting to the Department Chair, will work with the Department's leadership ...
Associate Medical Director - Post Acute Care
Chicago, IL ยท On-site
$179.50K - $307.73K/yr
The Clinical Operations Associate Medical Director is responsible for supporting the medical management staff ensuring timely and consistent medical decisions to members and providers. How you will ...
Associate Medical Director - Post Acute Care
Chicago, IL ยท On-site
$179.50K - $307.73K/yr
The Clinical Operations Associate Medical Director is responsible for supporting the medical management staff ensuring timely and consistent medical decisions to members and providers. How you will ...
Associate Medical Director - Interventional Pain
Chicago, IL ยท On-site
$94.06 - $153.91/hr
Clinical Operations Associate Medical Director Interventional Pain Carelon Medical Benefits Management Virtual: This role enables associates to work virtually full-time, with the exception of ...
Associate Medical Director - Interventional Pain
Chicago, IL ยท On-site
$94.06 - $153.91/hr
Clinical Operations Associate Medical Director Interventional Pain Carelon Medical Benefits Management Virtual: This role enables associates to work virtually full-time, with the exception of ...
Associate Medical Director - Post Acute Care
Chicago, IL ยท On-site
$179.50K - $307.73K/yr
Sign on bonus: $10, 000 Clinical Operations Associate Medical Director Carelon Medical Benefits Management Post Acute Care Benefit Utilization Management Schedule: 11:00AM-8:00PM CT. Will also ...
Associate Medical Director - Post Acute Care
Chicago, IL ยท On-site
$179.50K - $307.73K/yr
Sign on bonus: $10, 000 Clinical Operations Associate Medical Director Carelon Medical Benefits Management Post Acute Care Benefit Utilization Management Schedule: 11:00AM-8:00PM CT. Will also ...
Associate Medical Director - Outpatient Rehab
Chicago, IL ยท On-site
$188.05K - $294.91K/yr
Clinical Operations Associate Medical Director Carelon Medical Benefits Management Outpatient Rehab Utilization Management Review Preferred Shift: 8am-5pm Pacific Time Virtual : This role enables ...
Associate Medical Director - Outpatient Rehab
Chicago, IL ยท On-site
$188.05K - $294.91K/yr
Clinical Operations Associate Medical Director Carelon Medical Benefits Management Outpatient Rehab Utilization Management Review Preferred Shift: 8am-5pm Pacific Time Virtual : This role enables ...
... Associates for renewable terms of up to three years ... Appointees will be responsible for patient care and clinical operations. These positions do not ...
... Associates for renewable terms of up to three years ... Appointees will be responsible for patient care and clinical operations. These positions do not ...
Clinical Operation Associate information
See Chicago, IL salary details
$13.12 - $17.11
3% of jobs
$17.11 - $21.09
18% of jobs
$21.88 is the 25th percentile. Wages below this are outliers.
$21.09 - $25.08
20% of jobs
The median wage is $27.50 / hr.
$25.08 - $29.06
15% of jobs
$29.06 - $33.05
11% of jobs
$33.05 - $37.03
4% of jobs
$40.42 is the 75th percentile. Wages above this are outliers.
$37.03 - $41.02
5% of jobs
$41.02 - $45
8% of jobs
$45 - $48.99
6% of jobs
$48.99 - $52.97
6% of jobs
$52.97 - $56.96
3% of jobs
$13
$32
$56
How much do clinical operation associate jobs pay per hour?
What are the key skills and qualifications needed to thrive as a Clinical Operation Associate, and why are they important?
What are some common challenges Clinical Operation Associates face when coordinating clinical trials, and how can they be managed?
What are Clinical Operation Associates?
Full-time
Posted 17 days ago
Job description
- Conducting monitoring activities at assigned clinical trial site(s)
- Verifying the adequacy, reliability, and quality of data collected at clinical sites
- Ensuring the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries
- Subject safety, data integrity, and protecting the subject confidentiality
- Mentoring CRAs and other Clinical Operations (CO) staff
- Anticipating, recognizing and resolving issues in the served study sites and may oversee such activities of CRA/other CO staff
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Follows and ensures assigned studies are conducted in compliance with the currently approved Protocol(s)/Amendment(s), Standard Operating Procedures (Advanced Clinical or Sponsor SOPs), Code of Federal Regulations (CFR), Good Clinical Practice (ICH GCP), and local or country regulations
- Participates in Investigator feasibility and selection process by contacting sites to obtain feasibility information
- Conducts site qualification (pre-study), site initiation, routine interim and close-monitoring visits for assigned studies and sites
- Travels to research sites to conduct on-site visits as required
- Prepares site submissions to the Independent Ethics Committees (central and local) and to Competent/Regulatory Authorities, when applicable
- Assists with the development of Investigator and Institution contracts and budget templates, negotiates site budgets, and arranges site payments, when applicable
- Attends internal CRA Team meetings and participates in study team and sponsor meetings, as required
- Participates in Investigator meetings and assists with meeting preparation, when required
- Conducts monitoring visits per the monitoring visit frequency defined in the Monitoring Plan or as instructed by the study team and confirms visit attendance by sending visit confirmation letters to site staff
- Manages his/her own monitoring visit schedule for all assigned sites in accordance to the Monitoring Plan or the study needs
- Proactively schedules appointments to meet with site staff during monitoring visits
- Verifies that all delegated study staff at assigned sites are trained/certified and maintain compliance with requirements of the study protocol, informed consent process, data collection requirements, Investigational Product/Investigational Medical Device (IP/IMP) accountability/supply management, and safety reporting requirements
- Ensures the adequacy, reliability, and quality of all study data at assigned sites by performing source data review, source document verification, query resolution, and regulatory document and investigational product review
- Ensures that each assigned site is equipped with all necessary study equipment and supplies, and that the procedures (including sampling, processing, storage and shipment logistics) are appropriately adhered to
- Ensures subject safety, data integrity, and subject confidentiality
- Writes monitoring visit reports (MVRs) and sends site visit follow-up letters (FUL) as outlined in SOPs and study Monitoring Plans
- Routinely reviews the Investigator Site File (ISF) and the Pharmacy Binder (if applicable) for accuracy, timeliness and completeness
- Reconciles the Investigator Site File (ISF) with the Trial Master File (TMF) and uploads any documents obtained during monitoring visits to the TMF to ensure inspection readiness at all times
- Maintains awareness of key study performance indicators via regular communication with the site and clinical study team including Investigators, study coordinators, pharmacist, and other study personnel
- Discusses study status, timelines, patient recruitment, screening, enrollment, and retention efforts, ongoing patient status, IP/IMP supplies, study supplies, and any further requests or issues with each assigned site
- Conducts routine follow-up of open action items between monitoring visits to ensure timely closure
- Creates and maintains study/site trackers to successfully conduct monitoring visits
- Provides project specific training, mentoring, and/or co-monitoring with new CRAs.
- Completes assigned function area and study specific trainings
- Performs other duties as assigned per Advanced Clinical needs
QUALIFICATIONS:
- Must have 3-5 years of clinical monitoring experience
- The ideal candidate should have a Bachelor's degree in life sciences, a nursing degree, or be able to demonstrate equivalent experience
- Ability to travel up to an average of 80%, depending on project needs
- Must demonstrate clear understanding of the drug development process, clinical monitoring, and safety and regulatory requirements
- Must have excellent verbal and written communications skills as well as excellent interpersonal, presentation, and organizational skills with demonstrated attention to detail
- Must be able to work independently and in a team environment
- Must be computer literate with proficiency in MS Office including Outlook, Word, Excel, and PowerPoint as a minimum
- This role may be office and/or home-based however regular infrequent visits to a Company office will also be required.
About Advanced Clinical
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
201 - 500 Employees
Headquarters location
Deerfield, IL, US
Year founded
1994