- Provide procedural and regulatory guidance to clients and administrative team members
- Perform first screening of research protocols, preparing necessary documents for submission to the Committee, also preparation and management of a Study Synopsis and study chronology
- Edit consent documents, advertisements, and subject materials to assure conformance with FDA regulations, ICH guidelines and Salus policies, and prepare the forms for presentation to the IRB reviewer.
- Ensure eligibility for review by expedited process.
- Communicate and consult with sponsor, CRO representative, Project Management, and/or Principal Investigator to provide the outcome of IRB review determinations and stipulations in accordance with accepted timeframe
- Review responses to IRB stipulations and ensure the adequacy and completeness of responses, requesting additional material or information in order to address concerns
- Ensure timely release of accurate, quality audited written notification of reviewer's final determination, including generation of approval letters, consent documents, and all necessary materials for study conduct
- Maintain strong working knowledge of electronic submission system (IRBManager)
- Conduct quality audits of documents for grammatical and typographical errors, as needed
- Assist in documenting, version control, and recording of policy and procedure documentation
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Compliance Analyst - Austin, United States - Salus IRB
Description
SUMMARY: This position performs quality assessments of primarily minimal risk submissions and deliverables to ensure completeness, accuracy, and compliance with applicable regulations and standard operating procedures. This position works directly with Salus clients, assisting in the provision of regulatory guidance, and communicates on behalf of board members, requiring a high level of customer service skill, strong professionalism, and excellent written and verbal communication.
Additionally, this position supports continuous quality improvement and other quality initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage New Study Submissions
SECONDARY DUTIES AND SUPPORTING RESPONSIBILITIES
Upon request, assist in the performance of record keeping tasks including, but not limited to:
Quality Control Auditing
Administrative Support for Company Projects and Activities
Quality Improvement Initiatives
Sponsor, Client, Agency, and Accreditation Audits and Site Visits
Qualifications:
To perform in this position successfully, an individual must be able to perform each essential and secondary duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and abilities required, as well other requirements of the position.
Education and/or Experience:
1. At least three years' experience supporting clinical trials or IRB activities. Will consider other industry or related experience.
2. Working knowledge of and the ability to interpret all IRB-related regulations
3. Previous experience in quality review of regulatory documents
4. BA/BS degree preferred. CIP strongly preferred.
Knowledge, Skills, and Abilities:
Excellent communication, problem-solving and analytical skills required.
Ability to perform customer account collection activities using phone and email collection processes required.
Detail oriented with strong analytical skills, including math aptitude, and the ability to locate and reconcile amount differences to ensure the accuracy of detail and summary data required
Self-disciplined and capable of identifying and completing critical tasks independently and with a sense of urgency required.
Ability to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations.
Strong interpersonal skills with demonstrated ability to interact appropriately with positive attitude, including good judgment, high personal standards of work, able to initiate action and motivate others.
Tools and Technology
Working knowledge of software necessary to perform duties includes Microsoft Office (Excel, Outlook, and Teams). Additional working knowledge of Adobe Pro and IRBManager is helpful, but not required.
Work Environment and Expectations
Remote Position: Employee must reside in Texas and be able to commute to Austin for meetings when required.
Home-Based: Work must be performed in a private, controlled, quiet, and dedicated workspace. No work may be performed over public wi-fi.
Travel: Occasional travel to office in Austin, Texas required. Typically not more than once per month.
Equipment: Company laptop and headphones provided. Employee responsible for providing and maintaining high speed internet at their own cost.
Work Hours: Monday through Friday, 8:00am to 5:00pm Central Time. Some overtime may be required. Adjustments to core hours may be considered upon request.
Physical Demands: Must be able to maintain professional standards under routine conditions of non-negotiable time constraints and work independently with personal accountability for delegation of time towards daily work and tasks. This position must work successfully with other staff members over whom the employee will have no formal authority. Position requires multi-tasking.
This job description reflects the current assignment of essential functions and is not meant to be all-inclusive or in any way construed as an employment contract. Duties and responsibilities may be assigned or reassigned to this position at any time and may be modified to reasonably accommodate an individual with a disability or for other reasons solely at management's discretion. All position descriptions will be reviewed and updated at least once per year when the incumbent is reviewed or as attrition occurs.
