LINDA RETTELE
San Marcos,TX
Summary
Organized, dedicated, and ambitious business management professional with a strong ability to excel independently and with meticulous attention to detail. Expertise in business development, including successful navigation of contract and budget negotiations, as well as conflict resolution. Proven track record in these areas, poised to contribute skills and drive to the success of any organization.
Overview
30
30
years of professional experience
Work History
Site Financial Analyst II
Elligo Health Research
Remote
04.2023 - Current
- Develops strong working relationships and maintains effective communication with Elligo management, staff, customers, and sites
- Develops Site client budgets for each study
- Negotiates all MSA, Clinical Trial Agreements, WO and Amendments for 14 large Sites
- Works independently in the management of contract inventory, including contract development and budget negotiations
- Plays a key role in management timelines to ensure expeditious site start-up
- Responsible for reporting contract and budget negotiation progress to internal and external project teams
- Negotiates and manages all amendments and change orders to existing contracts
- Ensures that contracts are executed and centrally stored in accordance with corporate guidelines
- Collaborates with internal stakeholders to ensure proper understanding of the contractual and associated budgets
- Maintains various contractual templates in line with company branding and pricing strategy
- Ensures Sharepoint and Monday systems are updated as appropriate
- Participates in customer meeting preparations and discussions
- Liaises with third party vendors for provisions of quotations where requires
- Performs other duties as required by the department and Elligo leadership
Clinical Research Regulatory Specialist
Texas Diabetes & Endocrinology
Remote
02.2021 - 04.2023
- Responsible for overseeing the clinical trial regulatory maintenance from study submission through closeout
- This includes updating, cataloging, archiving, and processing department documentation
- Perform Continuing Reviews with several IRBs for all studies
- Perform Study Closeout with IRB and coordinate Study Termination preparation for all Sites
- Maintain all CVs, licenses, certifications, trainings, for all areas of site and study
- Upload and notify CRCs and sites of new ICFs or revised ICFs, Protocols, and IBs
- Organize regulatory information and track and control submissions for the clinical pharmaceutical and device protocols
- Maintain and oversee all eTMF and iTMF documents for each clinical trial
- Act as a liaison between Sponsor, IRB, and Clinical team to resolve queries, concerns, and resolution of issues
- Assure completeness of all regulatory documents prior to monitor visits and study closeouts
- Work effectively and coordinate well with Sponsors, monitors, CRCs, and site management
- Responsible for Protocol Training throughout study for staff on the Delegation of Authority Log
- Responsible for training all users of the eTMF/iTMF and ensuring training programs are kept up to date in the system
- Perform Q&A reviews on the regulatory documents for 3 locations and 75 current studies
- Study startup for Site side with regard to 1572s/FDFs
- Frequent use of Sponsor Trial Document portals such as Investigator Space (SIP), SharePoint, and Connect
- Conduct PowerPoint training sessions with new staff on the Regulatory requirements
- Keep track of all expiring documents for all studies
- Work with Department head to develop new initiatives to help the rapidly growing Research Dept
- Completed comprehensive training program to include ICD GCP E6 R2, FDA Regulations 21 CFR (Parts 11, 50, 54, 56), data management and electronic capture systems, informed consent process, and clinical trial operations following ALCOA-C principles, identification and reporting of AEs and SAEs, quality assurance, monitoring, and query resolution
Owner & Operator
DL Carts LLC
01.2018 - 11.2020
- Developed new business refurbishing, upgrading, and selling golf carts
- Maintained budget and promoted business through Facebook and other social media platforms
Account Supervisor
Panda Pediatrics
01.2002 - 01.2010
- Identified problem accounts with payors, investigated and corrected errors, followed up on incomplete account information, and resolved past due accounts
- Posted all credit and debit adjustments to patient accounts
- Composed routine correspondence to patients and payors
- Reviewed physician coding and monitored compliance with payor guidelines to ensure accurate and timely reimbursement
Contract Provider Relations Representative
Central Texas Medical Center / Central Texas Provider Network
01.2000 - 01.2001
- Liaison between providers with CTPN and contracted health plans
- Resolved claims and contract issues for network providers
- Created and distributed quarterly network newsletter
- Performed in-services for physician office managers regarding contract changes and concerns within CTPN
Reimbursement Supervisor
Austin Gastroenterology Associates, PLLC
01.1998 - 01.2000
- Resolved and monitored unpaid claims for a 9 physician group practice
- Solely responsible for commercial and managed care accounts (HMO, PPO, EPO, POS)
- Appealed claims with payors for correct reimbursement
- Worked with provider relations to resolve claim issues
- Coordinated patient payment arrangements
- Posted payments and adjustments on patient accounts according to contracted fee schedule
- Assisted in credentialing physicians
- Prepared daily deposits
Managed Care Coordinator
Texas Oncology, PA / South Austin Cancer Center
01.1996 - 01.1998
- Managed capitated contracts by tracking all patient account activity
- Created policies and procedures regarding managed care issues within the 8 physician Austin group practice
- Assisted in contracting and negotiating rated of reimbursement with managed care companies
- Was responsible for compiling, distributing, and educating staff and providers regarding changes in managed care contracts for the Austin group
- Performed case management for managed care patients
- Trained new and existing staff regarding managed care policies and procedures
- Responsible for generating, tracking, and monitoring referrals for all aspects of patient care
Patient Service Representative
Texas Oncology, PA / South Austin Cancer Center
01.1995 - 01.1996
- Obtained insurance referrals and authorizations for patient treatments and procedures
- Completed patient registration and verification of insurance benefits
- Prepared daily reconciliation, receipt control, and bank deposits
- Performed data entry of daily changes and ensured proper CPT/ICD coding and billing
- Assisted in financial counseling for patients
- Audited patient accounts for timely and accurate reimbursement
Education
Bachelor of Business Administration - Management
Texas State University
San Marcos, TexasClinical Research Fastrack - Clinical Research Trainee
GCP CITI Program Certification - Current
Skills
- Proficient in RealTime, SharePoint, Monday Board
- Proficient in Microsoft 365
- Proficient in Excel
- Proficient in Outlook
- Proficient in Powerpoint
- Team mentality
- Works great independently
- Excellent verbal and written communication
- Attention to detail
- Exceptional Organizational skills
Timeline
Site Financial Analyst II
Elligo Health Research
04.2023 - Current
Clinical Research Regulatory Specialist
Texas Diabetes & Endocrinology
02.2021 - 04.2023
Owner & Operator
DL Carts LLC
01.2018 - 11.2020
Account Supervisor
Panda Pediatrics
01.2002 - 01.2010
Contract Provider Relations Representative
Central Texas Medical Center / Central Texas Provider Network
01.2000 - 01.2001
Reimbursement Supervisor
Austin Gastroenterology Associates, PLLC
01.1998 - 01.2000
Managed Care Coordinator
Texas Oncology, PA / South Austin Cancer Center
01.1996 - 01.1998
Patient Service Representative
Texas Oncology, PA / South Austin Cancer Center
01.1995 - 01.1996
Bachelor of Business Administration - Management
Texas State University
Clinical Research Fastrack - Clinical Research Trainee
GCP CITI Program Certification - Current
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