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Post Doctoral Fellow, Biochemistry and Molecular Biology
Saint Louis University in Saint Louis, Missouri
 
 
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Date Posted 02/23/2022
Category
Postdoctoral-Chemistry
Employment Type FullTime
Application Deadline Open until filled
 
 
 
 
 

Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation’s oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.

All About You

Promotes and facilitates the regulatory compliance of the department by assisting the Regulatory Affairs Manager by independently completing a multitude of regulatory tasks; daily duties include submitting reports, amendments, and continuing reviews to the IRB, processing approved documents, creating essential study documents for regulatory files and outside sponsors, and creating and auditing all study regulatory documents; responsible for maintaining compliance by developing and exercising procedures to ensure timely document flow (paper and electronic) between the regulatory library, IRB, and outside sponsors; serves as short term back up in the event of the manager’s absence, including the preparation of IRB forms, sponsor and staff communications, and following established policies for resolution of regulatory episodes, including SAEs; in the future, creating and tracking training documentation for all staff on study protocol and amendments, and assisting in new protocol preparation will be expected.

Job Duties

  • Prepares and submits Continuing Reviews, processes all IRB approvals, creates and updates essential study documents such as Financial Disclosures and 1572 forms, tracks and processes out all necessary study documents required by each sponsor for study initiation, creates and prepares IRB Reports and Amendments, communicates via e-mail and phone with clinical trial sponsors regarding documents and submissions, creates, maintains, and audits regulatory books, coordinates monitor visits, maintains current credentials for the site, faculty and staff as well as outside vendors such as laboratory CLIA’s and CAP certifications.

  • Trains and supervises student workers.

  • Initiates and completes special projects such as long term storage of regulatory files, developing better communication and filing systems for the regulatory office, etc.

  • Assists in other Division office and study support duties, such as entering study data electronically during certain conditions as dictated by clinical trial sponsors.

  • Performs other duties as assigned.

Knowledge, Skills, and Abilities

  • Knowledge of IRB policies

  • Knowledge of FDA/Office for Human Research Protections regulations and ICH guidelines

  • Independent regulatory judgment

  • Ability to prioritize

  • Ability to be flexible

  • Time management skills

  • Ability to learn quickly

  • Ability to work independently and effectively

Minimum Qualifications

Bachelor’s degree; supplemented with three (3) years related work experience.

Saint Louis University requires COVID-19 vaccinations and a booster dose for all students, staff, and faculty who are physically present on our St. Louis campuses. As a prospective and/or a new employee at Saint Louis University, you will be/are required to comply with the University’s vaccination protocol. Proof of full vaccination is required before the start of employment in order to work at Saint Louis University. If you are not vaccinated, you are required to begin the vaccination process at the time of your first day of employment and submit proof of full vaccination within 30 days of your start date. Exemptions may be granted on the grounds of religious beliefs or medical circumstances. Failure to comply with the vaccine requirement within 30 days of an employee’s start date will result in termination of the employment. Proof of vaccine will be submitted through an online portal made available to you during your Workday onboarding tasks.

The University will require all students, faculty and staff to obtain a booster vaccine dose prior to their start date, This applies to:
• All adults over the age of 18 years who completed their vaccine series with Pfizer or Moderna at least 6 months ago.
• Those who received the J&J vaccine at least two months ago.

Function

Clinical Other

Scheduled Weekly Hours:

40

Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. We welcome and encourage applications from minorities, women, protected veterans, and individuals with disabilities (including disabled veterans). If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.

Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation’s oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.

All About You

Promotes and facilitates the regulatory compliance of the department by assisting the Regulatory Affairs Manager by independently completing a multitude of regulatory tasks; daily duties include submitting reports, amendments, and continuing reviews to the IRB, processing approved documents, creating essential study documents for regulatory files and outside sponsors, and creating and auditing all study regulatory documents; responsible for maintaining compliance by developing and exercising procedures to ensure timely document flow (paper and electronic) between the regulatory library, IRB, and outside sponsors; serves as short term back up in the event of the manager’s absence, including the preparation of IRB forms, sponsor and staff communications, and following established policies for resolution of regulatory episodes, including SAEs; in the future, creating and tracking training documentation for all staff on study protocol and amendments, and assisting in new protocol preparation will be expected.

Job Duties

  • Prepares and submits Continuing Reviews, processes all IRB approvals, creates and updates essential study documents such as Financial Disclosures and 1572 forms, tracks and processes out all necessary study documents required by each sponsor for study initiation, creates and prepares IRB Reports and Amendments, communicates via e-mail and phone with clinical trial sponsors regarding documents and submissions, creates, maintains, and audits regulatory books, coordinates monitor visits, maintains current credentials for the site, faculty and staff as well as outside vendors such as laboratory CLIA’s and CAP certifications.

  • Trains and supervises student workers.

  • Initiates and completes special projects such as long term storage of regulatory files, developing better communication and filing systems for the regulatory office, etc.

  • Assists in other Division office and study support duties, such as entering study data electronically during certain conditions as dictated by clinical trial sponsors.

  • Performs other duties as assigned.

Knowledge, Skills, and Abilities

  • Knowledge of IRB policies

  • Knowledge of FDA/Office for Human Research Protections regulations and ICH guidelines

  • Independent regulatory judgment

  • Ability to prioritize

  • Ability to be flexible

  • Time management skills

  • Ability to learn quickly

  • Ability to work independently and effectively

Minimum Qualifications

Bachelor’s degree; supplemented with three (3) years related work experience.

Saint Louis University requires COVID-19 vaccinations and a booster dose for all students, staff, and faculty who are physically present on our St. Louis campuses. As a prospective and/or a new employee at Saint Louis University, you will be/are required to comply with the University’s vaccination protocol. Proof of full vaccination is required before the start of employment in order to work at Saint Louis University. If you are not vaccinated, you are required to begin the vaccination process at the time of your first day of employment and submit proof of full vaccination within 30 days of your start date. Exemptions may be granted on the grounds of religious beliefs or medical circumstances. Failure to comply with the vaccine requirement within 30 days of an employee’s start date will result in termination of the employment. Proof of vaccine will be submitted through an online portal made available to you during your Workday onboarding tasks.

The University will require all students, faculty and staff to obtain a booster vaccine dose prior to their start date, This applies to:
• All adults over the age of 18 years who completed their vaccine series with Pfizer or Moderna at least 6 months ago.
• Those who received the J&J vaccine at least two months ago.

Function

Clinical Other

Scheduled Weekly Hours:

40

Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. We welcome and encourage applications from minorities, women, protected veterans, and individuals with disabilities (including disabled veterans). If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.

Apply
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