Regulatory Specialist

ALLIANCE CLINICAL LLC•Irving, TX

About The Position

The Regulatory Maintenance Specialist ensures research compliance protocols, federal regulations, industry guidelines, and company Standard Operating Procedures. This position requires ongoing knowledge of IRB and GCP/ICH guidelines and the federal regulations related to conducting clinical trials.

Requirements

Associate's degree in healthcare or related field, preferred.
2 years' experience in running research protocols, required.
2 years' experience in FDA regulations and GCP.
Proven track record of analytic reasoning skills and problem solving.
Exceptional attention to details and organization.
Must possess excellent verbal and written communication skills.
A proven ability to multi-task in a rapidly changing environment.

Responsibilities

Must have excellent organizational skills, attention to detail, interpersonal skills, and ahigh multi-tasking capacity.
Comply with all company policies, procedures, and conduct.
Strictly adhere to confidentiality and compliance standards.
Maintain knowledge of company Standard Operating Procedures (SOPs) to review and ensure SOP compliance.
Attend Site Initiation Visits, Routine Monitoring Visits, and Closeout visits.
Review and audit of protocols, informed consents, and regulatory documents for accuracy and compliance.
Ensure all versions of study-related documents are uploaded, filed, and training logged.
Track informed consent and protocol versions in the team project management portal.
Track all onsite CRO/Sponsor study visits within the team project management portal.
Provide consistent feedback to the study staff and managers to ensure compliance.
Assist with creating, routing for signature, and auditing the company training files.
Ensure all site staff CV packets are uploaded into the site credential common folder within Clinical Research IO (CRIO). The owner is the eReg maintenance specialist and sets a 90-daynotification for the document expiry date.
Ensure all CRIO, SOP, and study training certificates are uploaded to the site and study common training folders.
Collaborating with site staff to ensure expiring documents are renewed before the30-day expiration date and uploaded into CRIO.
Work with Clin Ops Manager to determine who will be delegated to a specific study and their tasks.
Link study staff to the delegated task and promptly complete signoff.
Assist with training new departmental staff on CRIO, regulations, and guidelines associated with electronic regulatory.
Creating eRegulatory folders within CRIO or sponsor-required eRegulatory platforms based on the Regulatory template.
Work within IRB platforms to obtain IRB approvals and submit continuing review and termination reports.
Upload IRB approvals, Submissions, Rosters, and route for the Principal investigator's signature.
Work with the site’s Regional Director and Clinical Operations Manager tonsure the calibration report is current. Ensure the report is uploaded into CRIO, assigned correctly, and a 90-day expiration alert is set.
Ensure that eISF is audit-ready before any monitoring visit or audit.
Work with the CRO and sponsors during routine monitoring visits to address and resolve any identified query or open action item.
Create a note to file for any placeholders when documents are stored outside Regulatory/CRIO or if the document does not apply to a specific study.
Once the study has been activated, Update 1572, Financial Disclosure, and the electronic Delegation of Authority log for any site staff changes.
Work with the CRO/Sponsor to be added to all study-related correspondence, including confirmation and follow-up letter distribution.
Create a site response form for all follow-up letters. Send the response form to the lead CRC to request responses for all documented action items and deviations. Please send it to the manager and file it in a shadow binder for internal use only.
Ensure the master subject log is current and filed in the Regulatory team shadow binder.
Oversee the key dates entered by all responsible parties within the study shell within CRIO.
Oversee the final review of regulatory and study documents before archiving.
After completing the closeout visit with the sponsor, and once the financial team has approved the termination submission to the IRB, work with the Regulatory manager toc reate a plan for transitioning the study source to be stored off-site.