Hi, I’m
Linda Bilong
Charlotte,NC
Summary
4 Years of experience as a field CRA for Phase I, II, III
2 Years of experience as a Clinical Research Nurse Ability to travel Nationally. Excellent working knowledge of GCPs, ICH Guidelines, and FDA Regulations. Self-starter with the ability to work proactively and independently. Team oriented with excellent customer service and interpersonal skills, including a positive attitude to tasks and projects.
Sound knowledge of medical terminology and clinical monitoring process.
Demonstrated ability to work independently and to effectively prioritize tasks.
Excellent command of English, written and spoken; professional communication via email. Preferred Therapeutic Area: Oncology knowledge with expert understanding in areas of Neurology, Respiratory, Infectious Disease, and Cardiovascular Disease.
Overview
13
years of professional experience
1
Certificate
Work History
Aya Healthcare
Cardiac Stepdown Registered Nurse
08.2024 - Current
Job overview
- Reduced complications post-surgery through diligent assessment, intervention, and timely communication with the interdisciplinary team.
- Served as an effective liaison between physicians, other healthcare providers, patients, and family members while coordinating optimal care planning efforts for each patient''s unique situation.
- Skillfully managed acute symptoms presented by patients experiencing chest pain or dysrhythmia, resulting in prompt medical intervention when necessary.
- Maintained detailed records of patient conditions, reactions and progress in alignment with physician orders.
Veristat
Clinical Research Associate II
04.2022 - 07.2024
Job overview
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to project team and develops action plans
- Maintains working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- Verifies process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate
- Demonstrates diligence in protecting confidentiality of each subject/patient
- Assesses factors that might affect subject/patient's safety and clinical data integrity at investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
- Per Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes Conducts Source Document Review of appropriate site source documents and medical records Verifies required clinical data entered in case report form (CRF) is accurate and complete via review of site source documents and medical records Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support effective conduct of clinical study data review and capture Verifies site compliance with electronic data capture requirements May perform investigational product (IP) inventory, reconciliation and reviews storage and security
- Verifies IP has been dispensed and administered to subjects/patients according to protocol
- Verifies issues or risks associated with blinded or randomized information related to IP
- Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labeled, imported and released/returned
- Routinely reviews Investigator Site File (ISF) for accuracy, timeliness and completeness
- Reconciles contents of ISF with Trial Master File (TMF)
- Ensures investigator/physician site is aware of requirement of archiving essential documents in accordance with local guidelines and regulations
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
- Supports subject/patient recruitment, retention and awareness strategies
- Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
- Understands project scope, budgets, and timelines for own and others' activities in clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
- Must be able to quickly adapt to changing priorities to achieve goals / targets
- May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
- Prepares for and attends Investigator Meetings and/or sponsors face to face meetings
- Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to project specific requirements
- Provides guidance at site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
- May provide training or mentorship to more junior level CRAs
- May perform training and sign off visits for junior CRA staff, as assigned
- May be mentored and assigned clinical operations lead tasks under supervision of experienced Clinical Operations Lead (COL), or operational line manager.
Guidehouse
Clinical Research Associate I
07.2020 - 04.2022
Job overview
- Performs Selection, Initiation, Monitoring, and Closure Visits at Investigator Sites according to project schedule
- Adheres to project guidelines and POI SOPs for monitoring requirements
- Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols
- Tracks and supervises collection of ongoing study data for purpose of regular project status reporting
- Collects and reviews regulatory documents as required
- Prepares site visit reports and telephone contact reports
- May participate in start-up process including reviewing protocols, reviewing CRFs, preparing Informed Consent forms, developing study documents, and organizing and presenting at investigator meetings
- Resolves site issues, including site recruitment challenges, and determines status for IP shipment
- Assists Project Manager (PM), Clinical Team Leader and/or Lead CRA (CTL/LCRA) with generation of study specific forms for completion by CRA and Investigators and follow up with teams to ensure timely completion and submission
- Works with PM/CTL/LCRA to secure authorization of site contracts
- Informs team members of completion of regulatory and contractual documents for individual sites
- Attends Investigator Meetings (IM) and study specific training meetings
- May translate, coordinate translations or review completed translations of critical documents
- Participates in feasibility and/or site identification activities
- Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with potential for participation
- Follows feasibility procedures for documentation of feasibilities performed
- Identifies documentation required for review by Regulatory Authorities and Ethical Committees
- Prepare Regulatory and Ethics Committee submissions
- Ensure written approvals are obtained and distributed appropriately prior to Site Initiation
- Prepares and attends Assessment Visit with senior CRA, CTL or Clinical Research Manager as required
- Conducts Assessment and/or Training Visits of CRA I/II as required
- Assists Project Team with day-to-day management of critical studies as required, including attendance at team meetings
- Organizes processes for interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with POI accountant, logging trial expenditure, receipts, invoices and income.
Novant Health
Clinical Research Nurse
04.2016 - 06.2018
Job overview
- Performed specimen collections and phlebotomy
- Developed advertising materials
- Acted as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
- Documented investigational product (drug/device) accountability
- Self monitored and self-audit responsibilities
- Developed informed consent document
- Maintained Clinical Trials for given SOPs
- Developed Case Report Forms
- Was assigned more complex studies
- Documented all written and phone correspondences with sponsor, labs, IRB and other regulatory organizations
- Maintained organized, accurate and complete study records
- Assisted Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects
- Entered data as appropriate for protocol (paper-electronic data capture)
- Accurately reported and tracked adverse events as defined by each study protocol
- Performed study close-out procedures
- Stored study records appropriately.
Sunrise Senior Living
Certified Nursing Assistant
12.2011 - 05.2016
Job overview
- Assist patients effectively manage routine bathing, grooming and other hygiene needs
- Promoted good oral and personal hygiene by aiding patients with shaving, bathing and teeth brushing
- Facilitated activities of daily living, including personal hygiene management, feeding and ambulation.
Education
South CollegeAsheville, NC
Bachelor of Science from Nursing
06.2020
ECPI UniversityCharlotte, NC
Practical Nursing from Nursing
01.2016
Skills
- Electronic Data Capture
- Source Document Verification
- Protocol adherence
- ICH Guidelines
- Informed Consent Process
- Site monitoring
- Adverse event reporting
Timeline
Cardiac Stepdown Registered Nurse
Aya Healthcare
08.2024 - Current
Clinical Research Associate II
Veristat
04.2022 - 07.2024
Clinical Research Associate I
Guidehouse
07.2020 - 04.2022
Clinical Research Nurse
Novant Health
04.2016 - 06.2018
Certified Nursing Assistant
Sunrise Senior Living
12.2011 - 05.2016
South College
Bachelor of Science from Nursing
ECPI University
Practical Nursing from Nursing
Certification
- BLS (AHA)
- ACLS (AHA)
- NIHSS Stroke Scale
Languages
French
Native or Bilingual
Therapeutic Areas
- Oncology, Breast Cancer – Phase I, II, Lung – Phase II, Bladder – Phase I, Cervical – Phase II, Acute Leukemia – Phase I, Colorectal Cancer - Phase II, Gastric Cancer - Phase III
- Central Nervous System, Alzheimer's Disease- Phase II, Bipolar Disorder – Phase II, Schizophrenia- Phase II
- Ophthalmology, Glaucoma- Phase III
- Infectious Disease, HIV/AIDS and FLU- Phase I
- Cardiovascular, Cardiac Arrest- Phase III
- Respiratory, Asthma - Phase I, COPD - Phase I
Clinical Trial Experience
PSSV150+
SIV 200+
RMV 400+
COV 50
Edcskills
- Inform
- Medidata Rave
- Omnicomm
- CTMS
- Impact Harmony
- Trial Master
- Impact
- E-clinical
- Siebel
- EDOCS
References
Available Upon Request
Similar Profiles
Andrea MullinsAndrea Mullins
Credentialing/Privileging Specialist II at Aya Healthcare/Aya LocumsCredentialing/Privileging Specialist II at Aya Healthcare/Aya Locums
Marilyn PerezMarilyn Perez
Contract Certified Pharmacy Technician at Aya Healthcare (Broward Healthcare North)Contract Certified Pharmacy Technician at Aya Healthcare (Broward Healthcare North)
Jordyn TylerJordyn Tyler
Travel Registered Nurse, Labor and Delivery at AMN Healthcare & AYA HealthcareTravel Registered Nurse, Labor and Delivery at AMN Healthcare & AYA Healthcare
Samaria SimsSamaria Sims
Certified Nursing Assistant at Premier Rehab And Healthcare-Aya HealthcareCertified Nursing Assistant at Premier Rehab And Healthcare-Aya Healthcare
Devyn ErseryDevyn Ersery
Server at Link & Pin ArboretumServer at Link & Pin Arboretum