Omaha, NE August 2017-Present Supervisor: LuAnn Larson, Director of Clinical Research Operations Clinical Research Associate - Assist with the conduct of clinical research trials as directed by the Research Coordinator - Provide direct support for the preparation, conduct and follow-up tasks associated with research study visits, including phlebotomy, sample processing, shipping, CLIA-waived lab testing, vital signs, and ECG recording
- Clinical Research Associate at UNMC Clinical Research Center
- submission to the physician at Think Whole Person Healthcare
- Student Research Assistant at UNO Biomolecular Laboratory
- at Lintecum & Nickell PC
1 year, 7 months at this Job
- Masters in Biomedical Sciences - Biomedical Sciences
- Bachelor of Science in Biotechnology - Biotechnology
Owner Operator LLC Contract Monitoring W-2 and 1099 short term contracts
Oct 2012 - Dec 2014 and March 2015 to present
Sr. Clinical Research Associate Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while demonstrating mastery and a deep understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. Provides clinical and technical support for Clinical Research Associates (CRA) I, II, and III and administrative staff. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures. May assume the role of a Lead CRA (LCRA) on projects by providing direction and guidance to project team, coordinating all monitoring activities, and communicating the status of these activities to the study Project Leader. Essential Functions:
•Communication - Maintains timely and effective communication among team members and site staff. Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution.
•Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested. Responds to findings without oversight. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities.
•Monitoring - Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits superior time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits.
•Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Highly proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed.
•Reporting and Tracking - Completes and submits reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
•Administrative - Prepares for and attends Investigator meetings. May attend Customer and Business Development meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring and/or training plans. Install action plans when required.
•Complete clinical site monitoring according to established ICH/GCP guidelines.
•Review Case Report Forms for clarity and consistency with source documents.
•Quality Assurance of SAE/IND safety reports with follow up until resolution.
•Review and ensure maintenance of sponsor and site regulatory files.
•Ensure accuracy of study test article inventory records
•Maintain thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.
•Participate in CRF development.
•Creation of training programs to new monitors when needed.
•Processing of invoices for payment to sites when applicable
•Assist Study Teams as well as site Principal Investigators with protocol requirements during study start up, IMV, and closure activities.
•Perform site audits when required in preparation for FDA or Global Compliance Audits.
•Consult new Principal Investigators on GCP, ICH, and overall study conduct.
•Electronic Data Capture training for new monitors and sites.
- Sr. Clinical Research Associate at M.C. Clinical Research LLC
- Clinical Compliance Officer (Auditing) at University of Miami Sylvester Cancer Center
- Sponsor Clinical Teams at RPS
- CRA at Nova Rx Contract W
2 years, 2 months at this Job
Areas of expertise
· Good knowledge of applicable clinical research regulatory requirements: i.e.. ICH GCP and relevant local laws. regulations and guidelines
· Clinical trial processing according to the protocol, standard operating procedures, good clinical practice and applicable regulatory requirements
· Working with Ethics Committee Submission Dossier
· Site identification, feasibility study and site selection
· Provide training to site as per trail protocol
· Support site for patient selection, enrolment and database maintenance
· Timely onsite Monitoring
· CRF retrieval as per the Clinical Management Plan
· SAE reporting to the Regulatory
• Lead Clinical study ‘TWILIGHT’ for Regulatory submission (DCGI, HMSC) and approval
• Awarded from ICRI-Bangalore for presentation on drug development Professional experience iProcess Clinical Marketing Pvt.Ltd,India | Jan 2015 – Present as Clinical Research Associate iProcess Global Research has grown from a few hospitals to managing research across several hundred hospitals in India and has also expanded beyond the borders to countries like Malaysia, Sri Lanka, South Africa and Singapore. iProcess manages all aspects of the study conduct from regulatory to study closeout. iProcess supports across all asian countries from Indian. Projects:- 1) Name:- TWILIGHT Description: - Ticagrelor with Aspirin or alone in high patients after coronary intervention. Sponsor: - Icahn School of Medicine at Mount Sinai, funded by Astra Zeneca Period: - Aug 2015 to Present Role;- Clinical Research Associate Responsibility:- Ø Creating and documenting as per regulatory requirement.. ICH GCP Ø Working with Ethics Committee and Regulatory authorities (DCGI and HMSC for GCT) Submission Ø Dossier for study approval Ø Site identification, feasibility study and site selection Ø Support different sites for study approval Ø Provide training to sites as per study protocol Ø Monitoring and mentoring sites for study queries, Patient selection and enrolments etc… Ø Anchoring all requirements/documents from sponsor to different sites Ø Reporting sponsor on plan, execution etc… 2) Name:- PROSE Description:- Prospective randomized on-x versus sjm valves Sponsor: On-X life technologies/Cryolife technologies Period; - Jan 2015 to Present Role;- Clinical Research Associate Responsibility;- Ø Perform Site Monitoring Visit and Site Close-Out Visit in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines. Ø Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, protocol related activities Ø Maintain accurate and timely sponsor/site correspondence and communication. Maintain updated Site Files and collection of the essential documents and project related documents during the site visits and maintain Central Clinical File Ø CRF retrieval as per the Clinical Management Plan. Ø Reporting of SAE to the Regulatory authority on time. 3) Name:- PERIOP-2 Description: - Post operative bridging therapy with low molecular weight heparin in high risk Patients on long term anticoagulant therapy Sponsor: - Lawson Health Research Institute Collaborators: Canadian Institutes of Health Research (CIHR) Pfizer Period;- Jan 2015 to Present Role;- Clinical Research Associate Responsibility;- Ø Perform Site Monitoring Visit and Site Close-Out Visit in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines. Ø Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, protocol related activities Ø Maintain accurate and timely sponsor/site correspondence and communication. Maintain updated Site Files and collection of the essential documents and project related documents during the site visits and maintain Central Clinical File Ø CRF retrieval as per the Clinical Management Plan. Ø Reporting of SAE to the Regulatory authority on time. Skills Ø Good team player Ø Good written and verbal communication skills in English Ø Results -oriented approach Ø Good problem solving, planning and managing skills Ø Quick learner and flexible Personal Details: D.O.B: 13th August 1986 Gender: Female Marital Status: Married Languages known: English, Hindi, Kannada, Telugu & Tamil. Referrals: Mr. Mohammed Saleem Director - iProcess Clinical Marketing Pvt.Ltd,India #29/1, 2nd Floor Hospital Road BANGALORE Bangalore KA 560051
- Clinical Research Associate (CRA) at iProcess Clinical Marketing Pvt.Ltd
2 years, 5 months at this Job
- Doctorate - Dental science
As a Lead Clinical Research Associate for global studies am responsible for coordinating the clinical Team of CTA's and CRAs for the studies to which I am assigned. I run the clinical day to day operations of the study and work closely with the Project Manager and Portfolio Directors to ensure the studies are completed per the protocol, on- time and on budget. I also create and edit the Clinical Monitoring Plan, help edit ECRF's and manage all clinical vendors for studies. My major responsibilities also include reviewing monitoring reports, provide mentoring and coaching to colleagues and site staff when needed. I also perform feasibility studies (pre-study site selection) when required. Manage/advise teams in therapeutic areas of proficiency as required or appropriate. Design monitoring tools. Provide support for the design of protocols as requested. Develop monitoring plans. Actively leads/participates in all study team meetings. Actively leads/plans/participates and presents at investigator meetings. Conduct training for colleagues or study teams. Manage a costs and implements appropriate actions to keep within budget. Participates in Bid defenses for the clinical aspect of the business as needed. I also co-monitor and can conduct all level of monitoring visits in accordance to GCPs and applicable local and international regulations and SOPs. This encompasses clinical trial material (CTM) accountability, regulatory document review and submission (as appropriate), clear and complete trip report writing and site management. Travel as needed for the studies to which I am assigned.
- Lead Clinical Research Associate at Worldwide Clinical Trials
- Manager at Clinical Trial Management, Pharm-Olam International
- Clinical Operations Leader/Senior Clinical Monitoring Associate/Clinical Monitoring Associate at PAREXEL, International, Decentralized
- Senior SOP Writer (Contractor) at UCB Biosciences
3 years, 4 months at this Job
- B. A. - Psychology
Clinical Research Associate for research in the Medical Oncology division of the Schiffler Cancer Center. Prepare invoices for the research studies in Medical Oncology section of the Schiffler Cancer Center. Monitor all studies, prepare and report all regulatory per SOPs, and FDA Regulations. All research related responsibilities. Screen and schedule all new patient referrals for all physicians within the practice. This includes communication with outside physician offices, gather patient records and coordinating with physicians within the practice. Prepare office policy and procedures according to QOPI and CoC standards. Business Data Analyst/Assistant to Senior Administrator of Clinical Services
- Clinical Research Associate at Wheeling Hospital
- Clinical Research Associate at Wheeling Hospital
- Data Manager for research at Wheeling Hospital
- Volunteer Teacher for Pre-K at Kids Club Bible Study at New Day Christian Center
5 years, 7 months at this Job
- Associate in Applied Science degree - Administrative Assistant
- - Business Math
collaboration with project teams is responsible for planning, monitoring, and coordinating clinical research studies at external study sites. As part of these activities, the Clinical Research Associate may also perform remote assessment of site activities, in addition to, onsite Investigator/site training, site qualification, initiation, interim, for cause, pharmacy and close out site monitoring visits. The Clinical Research Associate works closely with project team members and Sponsor, to plan and support coordination of research at participating clinical sites. This goal is achieved by evaluating compliance with regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), the study protocol and research objectives of the clinical trial.
- Sr. Clinical Research Associate at Craresources - Contract CRA
- Sr. Clinical Research Associate at inVentive - AbbVie FSP
- at ICON DOCs - BMS FSP
- at ICON ICR - Pfizer FSP
3 months at this Job
- B.A. - Education and Science
• Plan outcomes & resourcing for study team, create project timelines, & manage study progress
• Assess site & vendor feasibility; create questionnaires, lead conference calls, & negotiate contracts & budgets
• Mentor junior CRAs via training sessions & co-monitoring visits
• Additionally, perform all tasks listed under Clinical Research Associate I at Toolbox Medical Innovations
- Clinical Research Associate II at Toolbox Medical Innovations
- Clinical Research Associate I at Toolbox Medical Innovations
- Clinical Research Associate I at Exosome Diagnostics
- Senior Field Sales Manager at Vector Marketing Corporation
2 years, 5 months at this Job
- BS - Biology
• Perform all aspects of clinical research visits ranging from site qualification visits, initiation visits, routine monitoring visits to close out visits.
• Report study site conduct in a timely manner
• Establish and maintain good working relationship with site personnel's
• Ensure data integrity by instructing the site to answer queries and complete eCRFs in a timely manner according to Sponsor SOP
• Working with different types of EDC systems and performed remote monitoring.
• Submission of reports in a timely fashion
• Performs risk basked monitoring for various studies
• Monitors studies in Phase I and Phase II stages in accordance with applicable FDA guidelines, GCPs and SOPs
- Clinical Research Associate II at TFS - Clinical Contract Research Organization
- Clinical Research Associate at Boehringer-Ingelheim
- Clinical Data Associate at Boehringer-Ingelheim
1 year, 7 months at this Job
- Master of Arts in Human Resources Management - Human Resources Management
- Bachelor of Business Administration in Management - Management
* Conducts evaluation, initiation, routine monitoring and close out visits at each assigned study site, as outlined in the Study Monitoring Plan (SMP). * Identifies any Serious Adverse Events at the site, ensure timely reporting, and follow up. * Promptly brings any potential safety problems or significant protocol deviations to the attention of the Study Manager (SM). * Develops a thorough knowledge of the protocol, including all protocol specific requirements * Perform and coordinate all aspects of the clinical research monitoring and site management process in accordance with ICH-GCP, FDA guidelines, local regulations and company operating procedures (Phases II-IV) * Conduct site visits to assess protocol and regulatory compliance * Manages required documentation * Responsible for ensuring data will pass quality assurance audits * Develops and maintains collaborative relationships with investigational sites * Conducted various onsite visits: site selection, site initiation, close out, interim analysis and co-monitoring * Home-based office, site visit and expense report submissions * Travel to various investigational sites (Continental US) to monitor, Travel 80-95% * Review clinical trial tools to determine site progress/needs (remote monitoring) * Conducted protocol and procedural training for Investigational site to ensure proper conduction of study activities
- Senior Clinical Research Associate at ICON Clinical Research
- Senior Clinical Research Associate at PRA Health Sciences
- Principal Clinical Research Associate at PPD Inc
- Senior Clinical Research Associate at inVentiv Health
4 months at this Job
- Master of Business Administration - Business Administration
- Bachelor of Science in Mathematics - Mathematics
-Edison, NJ July 2018 to Present
Sollers is an organization specializing in graduate certificate programs and internships in clinical
research, clinical trial management, drug safety and pharmacovigilance.
Clinical Research Associate (Intern)
➢ Conducted in-house monitoring and generated timely and accurate monitoring reports.
➢ Maintained and reconciled all essential documents of the Trial Master File (TMF) in compliance with SOPs, GCP and ICH Guidelines.
➢ Managed study case report forms (CRFs) completed by the investigative sites and verified entries by validating accurate source documentation to support CRF entries.
➢ Collected IRB approval documents from any amended protocol, Informed Consent form, Investigator Brochure and any other subject facing material
➢ Performed regulatory binder review and retrieved documents, as appropriate for study TMF.
➢ Reviewed all SAEs, ensured Medical Director sign-off, and checked that sites are notified and that all company procedures are complied with.
➢ Reconciled the usage of investigational products at the site.
- Clinical Research Associate at Sollers
- Collector Specialist at Sallie Mae Bank Indianapolis- IN
- Customer Service Professional at Ivy Tech Community College Indianapolis-IN
- Clinical Specialist Assistant at AbbVie Pharma Waukegan-IL
8 months at this Job
- Associate of Applied Science - Nursing
- Master's in Business Administration - Business Administration
- Bachelor's in Business Administration - Project Management