Clinical Document Specialist
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Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
As a Clinical Document Specialist you will work with clinical staff to ensure study specific documents are complete and to provide assistance to the Celerion IRB Services team.
This position is Full-time and eligible for benefits. The Clinical Document Specialist will work remotely from any US geography, and will need to be able to travel to Lincoln, Nebraska for trainings about 1-2 times per year.
Essential Functions:
Create 1572 packets for all studies and ensure completeness prior to sponsor delivery and subsequent filing
Create Financial Disclosure documents for key staff members for each
Maintain electronic master signatures for all clinical staff
In collaboration with training team, maintain all current and historical copies of laboratory accreditations, reference ranges, staff Curriculum Vitae (CVs), medical licensures, and related forms. Coordinate updates when necessary.
Track IRB letters and ensure that the documents referenced are placed in the ISF
May be involved to ensure all protocol and protocol amendments are signed accordingly
Responsible for all study and non-study specific approvals and study expiry tracking
May be responsible for submitting any and all pertinent documents to the IRB or Sponsor for acknowledgement or approval
Perform Quality Control (QC) on all regulatory binders before the Quality Assurance (QA) audit of critical documents is completed
Respond to any QA findings in critical documents audit to ensure proper documents are placed in the regulatory binder
Special projects as needed
Assist Celerion IRB Services in the following:
Assist in the creation and QC of eConsents
Provide backup to IRB Services in the submission of documents to the IRB as well as processing the IRB Approval letters
Assist with Veeva-related administrative tasks (e.g. responding to Veeva Help Tasks)
Assist with research staff Financial Conflict of Interest survey
May be involved in providing back up to ICF writers
Knowledge/Skills/Education/Licenses:
Associate's degree in life sciences or equivalent preferred
Two or more years of industry experience or training is preferred
Strongly prefer experience with IRB/FDA and/or other regulatory bodies and guidelines
Must have strong organizational, attention to detail, multi-tasking, and time management skills
Excellent oral and written communication skills
$22 - $25 an hour
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
Clinical Document Specialist
To see similar active jobs please follow this link: Remote Development jobs
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
As a Clinical Document Specialist you will work with clinical staff to ensure study specific documents are complete and to provide assistance to the Celerion IRB Services team.
This position is Full-time and eligible for benefits. The Clinical Document Specialist will work remotely from any US geography, and will need to be able to travel to Lincoln, Nebraska for trainings about 1-2 times per year.
Essential Functions:
Create 1572 packets for all studies and ensure completeness prior to sponsor delivery and subsequent filing
Create Financial Disclosure documents for key staff members for each
Maintain electronic master signatures for all clinical staff
In collaboration with training team, maintain all current and historical copies of laboratory accreditations, reference ranges, staff Curriculum Vitae (CVs), medical licensures, and related forms. Coordinate updates when necessary.
Track IRB letters and ensure that the documents referenced are placed in the ISF
May be involved to ensure all protocol and protocol amendments are signed accordingly
Responsible for all study and non-study specific approvals and study expiry tracking
May be responsible for submitting any and all pertinent documents to the IRB or Sponsor for acknowledgement or approval
Perform Quality Control (QC) on all regulatory binders before the Quality Assurance (QA) audit of critical documents is completed
Respond to any QA findings in critical documents audit to ensure proper documents are placed in the regulatory binder
Special projects as needed
Assist Celerion IRB Services in the following:
Assist in the creation and QC of eConsents
Provide backup to IRB Services in the submission of documents to the IRB as well as processing the IRB Approval letters
Assist with Veeva-related administrative tasks (e.g. responding to Veeva Help Tasks)
Assist with research staff Financial Conflict of Interest survey
May be involved in providing back up to ICF writers
Knowledge/Skills/Education/Licenses:
Associate's degree in life sciences or equivalent preferred
Two or more years of industry experience or training is preferred
Strongly prefer experience with IRB/FDA and/or other regulatory bodies and guidelines
Must have strong organizational, attention to detail, multi-tasking, and time management skills
Excellent oral and written communication skills
$22 - $25 an hour
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.