Andrea Haak
Brooklyn,NY
Summary
Talented professional that is considered a knowledgeable leader and dedicated problem solver. Brings 16 years of valuable expertise to forward company objectives. Analytical and detail-oriented professional with good judgement, sound critical thinking, and problem-solving abilities. A seasoned expert at establishing and implementing goals and objectives, identifying and managing risks and developing business potential to make all stakeholders happy. Experienced in coordinating projects, programs and improvements focused on making sure products meet all relevant domestic and international regulatory requirements. Also an organized Operations Lead with a background in motivating, coaching and overseeing teams by employing excellent interpersonal and multitasking skills.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Clinical Operations Lead (FSP) / Sr. SSU & Regulatory Specialist
Syneos Health
07.2021 - Current
- Perform remote feasibility/Pre-Study Visits for site selection and building/updating them in the Clinical Trial Management System (CTMS) in collaboration with primary site monitor and Global Study Managers (GSMs) for activation dates, etc.
- Site recruitment/retention planning & enrollment tracking [including creating a pool of focused sites for DEI initiatives].
- Responsible for executing protocol within timelines/budget as well as risk assessment (developing Site Monitoring Plan (SMP).
- Review of Site Monitoring Reports (SMRs) from Clinical Research Associates (CRAs).
- Managed, developed and distributed essential document binders and study materials/tools including protocol ancillary supplies, etc.
- Verified quality of deliverables and conformance to specifications from external vendors before submitting to sites.
- Maintain Trial Master File (eTMF), monitor site queries while ensuring AEs/SAEs are reviewed/reported in a timely manner
- Manage communication and country submissions/approvals to IRB as well as study communications/newsletters to all stakeholders (sites, GSMs, and CRAs) through various processes such as email, kickoff meetings, Investigator Meetings, CRA calls, team calls, etc
- Mentoring and leading sub groups within local study team (LST) for study start-up (SSU), conduct, and close out for multiple trials whether it be SSU, amendments, site fires, etc; also serving as country point of contact (POC) as well as site/CRA POC in regards to point of escalation.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Recommended improvements to processes.
- Evaluated current processes to develop improvement plans; reviewed internal systems and organized training plans to address areas in need of improvement.
- Monitored project progress, identified risks and took corrective action as needed while maintaining open communication by presenting regular updates on project status to stakeholders.
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
- Tracked project and team member performance closely to quickly intervene in mistakes or delays.
Clinical Research Coordinator
UNC Lineberger Comprehensive Cancer Center
11.2020 - 07.2021
- Coordinate Leukemia patient appointments, protocol mandated assessments, and specimen collection in a timely manner.
- Maintain progress note documentation, ensuring concomitant medications and financial calendars are accurately up-to-date.
- Manage subject data in eCRF, answer queries, and keep AEs and SAEs accurately updated for study audits.
- Assist in assessing patients for possible adverse events, dose delays, and dose modifications and provide oral IP administration instruction.
- Serve as first point of contact for study patients, physicians, sponsors, and schedulers while participating in weekly multi-study meetings.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Followed informed consent processes and maintained records.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Clinical Research Coordinator
Aesthetic Solutions
03.2017 - 11.2020
- Served as main point of contact to patients, PI, and study monitors for up to seven studies (Pivotal Studies, Phases 1, 3-4).
- Accurately recorded data for multiple studies in accordance with ICH/GCP guidelines while meeting Sponsor timelines.
- Held responsibility for handling regulatory document submission for all studies within the practice from study start-up to close.
- Performed appropriate medical tests on patients as required by each individual study as well as assist with IP administration.
- Handled budget and contract negotiations along with patient reimbursement.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Followed informed consent processes and maintained records while also assisting assess possible adverse events.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Gathered, processed, and shipped lab specimens.
- Tracked contracts for management and issued regular tracking reports covering current status and upcoming milestones.
- Administered testing with electrocardiogram for patients experiencing events and as screening tool and/or when required by protocols.
Clinical Research Coordinator & Practice Manager
Dadeland Dermatology Group
06.2007 - 03.2017
- Coordinate all assessments and procedures for study patients (Phases 2-4) while ensuring high quality EDC entry.
- Arrange storage of patient information (study & practice related) to be organized and secure per HIPAA guidelines.
- Provide and ensure proper training to clinical study team members as well as office staff to increase productivity.
- Schedule patient appointments, vendor visits, and monitor meetings to ensure a smooth day-to-day operation.
- Manage office payroll and accounting as well as clinical trial budget, contract negotiations, and patient reimbursement.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Followed informed consent processes and maintained records while assisting in assessing for possible adverse events.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Gathered, processed, and shipped lab specimens.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Managed daily practice operations to optimize appointment scheduling, patient records management and billing functions.
- Provided outstanding support to entire staff which helped improve process flow and boosted efficiency.
- Provided supervision and management to team of support personnel while boosting staff morale by offering constructive feedback and specific direction and addressing/remedying all patient or team member issues.
- Developed and implemented strategies to improve patient access, satisfaction and care quality.
- Oversaw accounting, budgeting, and financial reporting.
- Developed policies and procedures for effective practice management.
- Trained interns and newly hired team members on office procedures and computer system.
- Assessed processes and procedures, complying with OSHA, and HIPAA regulations.
- Communicated closely with patients, ensuring medical information was kept private.
- Developed and updated policies and procedures, maintaining compliance with guidelines relating to HIPAA, benefits administration and general liability.
- Tracked contracts for management and issued regular tracking reports covering current status and upcoming milestones.
Receptionist & Medical Assistant
Dadeland Dermatology Group
01.2004 - 01.2011
- Greeted incoming visitors and customers professionally and provided friendly, knowledgeable assistance.
- Answered phone promptly to respond to inquiries from callers seeking information. and directed incoming calls to correct offices.
- Confirmed appointments, communicated with clients, and updated client records while maintaining confidentiality of information regarding clients and company.
- Restocked supplies and submitted purchase orders to maintain stock levels as well as sanitizing, restocking, and organizing exam rooms and medical equipment.
- Directed patients to exam rooms, fielded questions, and prepared for physician examinations.
- Obtained client medical history, medication information, symptoms, and allergies.
- Scheduled appointments, registered patients, and distributed sample pharmaceuticals as prescribed.
- Documented vital signs and health history for patients in clinic and hospital environments.
- Assisted physicians with minor surgeries, including preparing operating room and sterilizing instruments.
- Maintain flow of clinic and coordinate follow up care for patients.
- Verified patient insurance coverage and collected required co-payments.
- Prepared lab specimens for diagnostic evaluation.
- Explained procedures to patients to reduce anxieties and increase patient cooperation.
- Manage front-desk phone calls including pharmacy inquiries, appointment scheduling, and patient concerns
- Document medical visits and procedures including scribing.
Education
Pursuing Associate's Degree in Arts -
Miami Dade College
Miami, FloridaHigh School Diploma -
John A. Ferguson Sr. High
Miami, Florida06.2007
Skills
- Ethics Management
- Project/Trial Management
- Process Improvement
- Stakeholder Engagement
- Risk Assessment
- Contract Management
- Cross-functional Team Leadership
- Analytical Skills
Certification
- CITI Programs: GCP for Clinical Trials with Investigational Drugs, Biologic's, and Devices Course
- CITI Program: Shipping and Transport of Regulated Biological Materials (IATA & DOT)
- CITI Program: GCP for Clinical Trials with Investigational Drugs and Medical Devices(U.S. FDA Focus) Course - ICH/GCP
- CITI Program: Group 1 Biomedical Research
General Skills
Microsoft Office Suite, Google Workspace, type 65 words per minute, Fluent in English, Proficient in Spanish
Referrals
Vicki Hurley - vicki.hurley@roche.com | Silvi Kuld - silvi.kuld@roche.com
Laurie Kirkland - laurie.kirkland@iqvia.com *More referrals can be provided upon request.
Relevant Training
- MedAvante
- Xcellerate
- Greenphire
- Signant Health
- CTMS
- ETMF
- Protocol First
- Inform Oracle
- MyClin
- E-bracket/Y-Prime
- Florence eReg
- Medtrials Core
- Oncore
- Premier Research
- ECaseLink
- Almac
- IMedidata
- ICON
- ERT
- CPR Certified
- Canfield Certified
- ECG Certified
Timeline
Clinical Operations Lead (FSP) / Sr. SSU & Regulatory Specialist
Syneos Health
07.2021 - Current
Clinical Research Coordinator
UNC Lineberger Comprehensive Cancer Center
11.2020 - 07.2021
Clinical Research Coordinator
Aesthetic Solutions
03.2017 - 11.2020
Clinical Research Coordinator & Practice Manager
Dadeland Dermatology Group
06.2007 - 03.2017
Receptionist & Medical Assistant
Dadeland Dermatology Group
01.2004 - 01.2011
Pursuing Associate's Degree in Arts -
Miami Dade College
High School Diploma -
John A. Ferguson Sr. High