Brianne Hedstrom
Altasciences
Fargo,ND
28
years of professional experience
Team contributor with strong organizational capabilities. Experienced in handling numerous projects at once while ensuring accuracy. Effective at prioritizing tasks and meeting deadlines. Equipped with strong time management and problem-solving abilities, willingness to learn, and communication skills.
Work History
IRB Submissions Specialist
4 Years 5 Months- Prepared and tracked IRB submissions for Phase I - II clinical studies through various electronic IRB portals.
- Functioned as the main liaison between Principal Investigators, Sponsors, clinical sites, and the IRB.
- Collaborated with sponsors and study teams to resolve IRB clarifications, ensuring timely issue resolution and adherence to study timelines.
- Collaborated with Regulatory department for submissions to the FDA and Health Canada across 3 internal clinical sites in the USA and Canada.
- Implemented process improvements to strengthen and track turnaround times and quality.
- Streamlined interdepartmental communication to enable efficient handoffs of approved materials, minimizing delays in study timelines.
- Maintained organized, accurate records to ensure audit-ready documentation and facilitate regulatory inspections.
- Followed all company policies and procedures to deliver quality work.
- Developed training materials and databases to enhance staff proficiency and productivity.
Associate Medical Writer
2 Years 6 Months- Drafted and revised study specific informed consent forms (ICF) in accordance with SOPs, Sponsor requirements, ICH-GDP and local IRB guidelines for multiple concurrent clinical studies.
- Conducted quality control reviews of ICFs for grammar, consistency, and alignment with SOPs, Sponsor requirements, ICH-GDP, and local IRB guidelines, ensuring compliance for multiple concurrent clinical studies.
- Ensured timely delivery of medical writing assignments for multiple concurrent studies, contributing to project timelines and overall study success.
- Collaborated with cross-functional study teams to clarify content and resolve document discrepancies, enhancing document accuracy and integrity.
- Applied ICH and GCP guidelines to maintain regulatory compliance across written submissions.
- Ensured compliance with industry guidelines and regulations by closely adhering to established writing standards and processes.
- Contributed to the development and maintenance of databases to streamline efficiency and productivity.
Clinical Administrative Assistant
4 Years 5 Months- Assisted with clinical tasks, including taking vitals and processing laboratory specimens, to ensure efficient clinic operations.
- Acted as primary liaison between clinical teams and external vendors.
- Maintained trial master file (TMF) for audit-ready documentation at all times.
- Followed strict HIPAA guidelines to protect participant privacy.
- Reviewed and archived study materials to maintain compliance with guidelines and SOPs.
- Completed quality control review of study-specific source documentation.
- Arranged shipment logistics for biological specimens to ensure timely delivery to laboratories. of human biological specimens to facilitate timely laboratory processing.
- Prepared clinical correspondence forms and administrative materials for study and office workflows.
Administrative Assistant and Scheduler
1 Year 5 Months- Coordinated calendars, meetings, and travel plans to enhance daily administrative operations.
- Scheduled appointments and kept patient or client records current in administrative systems.
- Handled correspondence, phone inquiries, and message routing with accuracy and professionalism.
- Operated multi-line phone system, routed calls, delivered messages, and greeted visitors to maintain effective communication.
- Facilitated connections between patients, clinics, and nuclear medicine technicians to ensure timely, compassionate care.
- Protected sensitive information by following privacy policies and using secure filing practices.
- Managed supply orders for nuclear medicine to maintain operational efficiency.
Expedite Medical Service Coordinator
4 Years 1 Month- Supported time-sensitive medical readiness assessments and physical, behavioral, and dental evaluations for military personnel, veterans, and government agency employees within provider network under urgent deadlines.
- Acted as liaison between providers and stakeholders to address scheduling roadblocks and documentation delays.
- Identified scheduling errors and service issues, escalating concerns to ensure time-critical timelines were met.
- Managed heavy inbound and outbound phone triage queues and routed requests to appropriate resources.
- Communicated with service members, network clinics, and government clients to resolve pending care actions and support follow-up.
- Reviewed, audited, and retrieved healthcare records, exam results, and documentation to maintain compliance with strict federal and military standards.
- Facilitated communication among patients, providers, and payers to address documentation and service issues.
In-Home Caregiver
2 Years 4 Months- Delivered daily personal care, ensuring comfort and dignity through bathing, dressing, grooming, medication administration, and mobility assistance.
- Provided daily personal care, supporting bathing, grooming, dressing, and mobility needs.
- Monitored health changes and reported concerns promptly to family and care providers.
- Facilitated household tasks, promoting a safe and welcoming environment through cooking, shopping, laundry, light cleaning, and maintenance.
- Prepared nutritious meals and maintained medication reminders for consistent routine adherence.
Counselor
2 Years 5 Months- Reinforced individualized support plans to promote independence and goal achievement.
- De-escalated challenging behaviors using calm communication and approved intervention techniques.
- Supported individuals with daily living tasks and community participation in home-based settings.
- Assisted with personal care routines while maintaining dignity, privacy, and safety.
- Monitored client needs and communicated concerns to supervisors and interdisciplinary care teams to ensure comprehensive support.
- Coordinated community outings and appointments to align with person-centered support goals, promoting client engagement.
- Documented behavioral observations and progress notes to enhance service coordination.
- Maintained confidentiality while following agency policies, procedures, and care standards.
Customer Service Representative
5 Years 5 Months- Greeted customers promptly and answered questions with clear, polite communication to enhance customer experience.
- Helped shoppers find products and explained pricing, store policies, and other store details.
- Handled checkout transactions with accuracy while supporting smooth front-end operations.
- Trained new employees on store procedures and daily tasks to ensure consistent service delivery.
- Maintained current inventory records and organized stock areas to support efficient store operations.
Education
No Degree - General Education
High School Diploma
Skills
Problem solving
Analytical thinking
Regulatory documentation
Quality assurance
Team collaboration
HIPAA compliance
Regulatory compliance
Knowledge of medical terminology
Microsoft 365 proficiency
GCP compliance training
Time management
Multitasking
Attention to detail
Organizational skills
Task prioritization
Adaptability
Timeline
IRB Submissions Specialist
Altasciences
03.2022 - 08.2026Read More
Associate Medical Writer
Altasciences
09.2019 - 03.2022Read More
Clinical Administrative Assistant
Algorithme Pharma
04.2015 - 09.2019Read More
Administrative Assistant and Scheduler
DMS Health
11.2013 - 04.2015Read More
Expedite Medical Service Coordinator
LHI
08.2009 - 09.2013Read More
In-Home Caregiver
Daniel Flaherty
04.2006 - 08.2008Read More
Counselor
Home and Community Options Inc.
03.2004 - 08.2006Read More
Customer Service Representative
Superfair Foods
08.1998 - 01.2004Read More
Winona State University
No Degree from General Education
Read More
St. James High School
High School Diploma
Read More