Senior Clinical Research Associate II - Avance Clinical
(2026-04)
- Conduct site and investigator feasibility activities.
- Coordinate Human Research Ethics Committee submission requirements to completion.
- Develop study-related documents or plans under supervision of the study Project Manager.
- For a multi-site study, oversee and lead the operations of the clinical team as the Lead CRA including development of Clinical Monitoring Plan, study-specific annotated report, reviewing Visit Reports.
- Perform all activities (preparation, execution, and follow-up) associated with onsite or remote PreStudy Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV) and Close-out Visits (COV).
- Generate and maintain high quality confirmation letters, site visit reports, follow-up letters and other documentation related site monitoring and management to ensure compliance with ICH GCP, study protocol and regulatory requirements.
- Monitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability, meet with site personnel, and ensure procedures are conducted in accordance with the protocol and ICH GCP.
- Perform protocol review as requested.
- Raise data queries in the Case Report Form (CRF) where discrepancies are identified and work with site staff to ensure timely and accurate resolution.
- Collect TMF documentation from site and ensure accurate and timely filing as per SOP requirements.
- Maintain effective site communication to proactively manage on-going study expectations and issues.
- Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
- Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
- Provide guidance and mentoring to less experienced staff during co-monitoring visits and facilitating accompanied site visits.
Senior Clinical Research Associate - SystImmune
(2025-06 - 2025-06)
Short-term Contract Position, Extension Not Available
- Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits.
- Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug.
- Assist and support the collection of key documents from sites to enable site activation timely.
- Assist in the development of study/program plans and or SOP Development/updates as directed by the Clinical Project Manager.
- Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters or other potential creative solutions).
- Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication.
- Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries.
- Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, and all investigator and site correspondence.
- Identify and complete follow-up of SAEs at study sites.
- Ensure appropriate and timely submission of documents to the Trial Master File.
- Perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP.
Senior Clinical Research Specialist - Planet Pharma
(2025-05 - 2025-06)
Short-term Contract Position, Extension Not Available
- Identified and investigated discrepancies in study documentation by applying clinical protocol and GCP knowledge and developed processes to mitigate reoccurrence throughout study phases.
- Conducted in-house and site reviews of associated documentation and participated in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, internal SOPs, and US and OUS regulations.
- Assessed current processes, identified opportunities and proposed solutions to improve process efficiency within and across related functional areas.
- Partnered with cross-functional teams (e.g., clinical data management, field teams) with query management, data reviews and resolution.
Site Care Partner II - Parexel International - Uxbridge, UK
(2024-07 - 2024-12)
Short-term Contract Position, Extension Not Available
- Collaborated with Site Monitor to ensure all activities post SIV are complete, ensuring the site and Site Monitor are prepared for FSFV (First Subject First Visit).
- Ensured the site has IP and sufficient supplies throughout the lifecycle of the study.
- Collaborated with the site, implementing recruitment strategies to meet enrollment goals.
- Responsible for the timely review and approval of Site Monitor's monitoring reports.
- Responsible for quality events and mitigation.
- Responsible for Investigator payment oversight and mitigation.
- Supported the revision and submission of Informed Consent Documents and amendments.
- Responsible for drug accountability and reconciliation as directed.
- Responsible for ensuring site preparedness for and executes the conduct of the Close Out Visit.
Senior Clinical Research Associate - ICON DOCS Global - USA
(2020-06 - 2024-06)
- Was responsible for monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs to support new drug applications.
- Supported project teams in the placement, implementation, communication, site management, recruitment and retention.
- Served as main contact for assigned study sites.
- Conducted site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP.
- Assisted with or oversaw study start-up activities, including feasibility, pre-study activities and site selection.
- Collected, reviewed and tracked essential/regulatory documents.
- Participated in and completed all general and study specific training as required.
- Participated in investigator, client and project team meetings, which included presentations.
- Created and implemented subject enrollment strategies for assigned study sites.
- Ensured proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials.
- Performed site management activities and provided ongoing updates of site statuses to the Clinical Project Manager.
- Conducted remote monitoring and completed related activities in accordance with study specific Monitoring Plan.
- Utilized systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP.
- Assisted with project-specific activities as member of Project Team.
- Participated in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.).
- Where applicable, provided support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
- Provided regular updates to Sponsor/ Client.
- Where applicable, supported or oversaw contract negotiation with study sites, Investigator payments and tracking of site payments.
- Managed ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans.
- Identified and anticipated site issues and implement corrective and preventive actions or escalate as appropriate.
Lead Clinical Research Associate/Mentor - ICON DOCS Global - USA
(2020-12 - 2024-06)
- Provided training/support to Clinical Research Associate's on early development operation trials.
- Co-monitored/Mentored new Clinical Research Associate staff.
- Provided relevant expertise and knowledge to new Clinical Research Associate staff.
- Assisted with the on-boarding of new Clinical Research Associate staff.
Senior Clinical Research Associate - Covance - USA
(2020-01 - 2020-06)
Covance acquired RCRI in January 2020
- Served as contact for project team and investigational sites.
- Conducted site contacts and documented contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
- Supported project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study and discuss potential study risks and opportunities with the Project Manager.
- Monitored site performance and implemented action plans for sites not meeting study expectations.
- Prepared for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
- Performed CRF review, query generation and resolution against established data review guidelines, client data management systems, as assigned by management.
- General On-Site Monitoring Responsibilities: PSVs, SIVs, RMVs and COVs, and acted as a co-monitor for on-site RMVs, as needed.
- Performed monitor visits onsite and remotely, (i.e. Phone PSVs, Phone SIVs, remote RMVs, and remote COVs) as required by the monitoring plan.
- Submitted submissions and notifications to Ethics Committees and Regulatory Authorities.
- Managed sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
- Served as a mentor to less experienced In-House CRA staff.
Clinical Research Associate II - Covance - USA
(2018-06 - 2020-01)
Covance acquired RCRI in January 2020
- Supported Project Teams with the management of research studies from study initiation through close-out activities (informed consent development, data and query management and investigational site management).
- IRB/EC management including site application assistance and approval tracking.
- Was responsible for the compilation and maintenance of site regulatory documentation.
- Adhered to good clinical practices, study protocols, and applicable regulations.
- Prepared study progress reports for project team and sponsor. Prepared for safety management review meetings (e.g., binders, agenda preparation, and meeting minutes).
- Performed site qualification, site initiation, interim monitoring (remote and/or on-site) and study close-out activities of study centers for compliance with clinical protocol and applicable regulations.
- Was responsible for the maintenance of study specific files and documentation.
- Reviewed and managed clinical site payments.
- Authorized to have direct communication with the clinical study sites and conduct daily activities supporting the study/project.
- Ensured reported trial data are accurate and complete, and participated in clinical data processes.
Clinical Trial Coordinator - Nuvaira Inc. - Plymouth, MN, USA
(2016-03 - 2018-06)
- Entered data and managed assigned study databases/trackers.
- Assisted with management of in-house study paper and electronic folders.
- Managed device shipments, stocking levels and tracking.
- Assisted with site payments during studies.
- Assisted in development of new tracking tools.
- Assisted with assembly and distribution of study materials.
- Processed clinical trial documents translation.
- Assisted with clinical meetings, schedule, record and distributed meeting minutes.
- Supported study participants, including Clinical Research Associates (CRAs) and clinical site personnel.
- Routed documentation for appropriate review.
- Assisted with dissemination of clinical trial correspondence.
- Handled confidential and proprietary information.
- Proactively identified and resolved operational project issues and participated in process improvement.
- Vendor management.
Clinical Research Coordinator - Clinical and Translational Science Institute- University of Minnesota - Minneapolis, MN, USA
(2015-01 - 2016-03)
- Recruited, interviewed and evaluated subjects for study feasibility.
- Consented patients for study trials.
- Collected, preformed or obtained subject; medical history, vitals, electrocardiograms, pulmonary function testing, injections and blood lab draws.
- Accurately completed source documentation, case report forms, query resolution.
- Completed and submitted study documents to IRB for approval.
- Assessed needs of the study and facilitated implementation as necessary.
- Followed Good Clinical Practice (GCP) guidelines in the conduct, performance and recording of clinical research.
Clinical Research Coordinator - Minnesota Lung Center/Minnesota Sleep Center - Minneapolis, MN, USA
(2013-01 - 2015-01)
- Consented patients for study trials.
- IRB/EC management including site application assistance and approval tracking.
- Responsible for the compilation and maintenance of site regulatory documentation.
- Adhered to good clinical practices, study protocols, and applicable regulations.
- Prepared study progress reports for project team and sponsor.
- Prepared for safety management review meetings (e.g., binders, agenda preparation, and meeting minutes).
- Supported Project Teams with the management of research studies from study initiation through close-out activities (informed consent development, data and query management, investigational site management, etc.).
- Performed site qualification, site initiation, interim monitoring (remote and/or on-site) and study close-out activities of study centers for compliance with clinical protocol and applicable regulations.
- Responsible for the maintenance of study specific files and documentation.
- Reviewed and managed clinical site payments.
- Authorized to have direct communication with the clinical study sites and conduct daily activities supporting the study/project.
- Performed phlebotomy and processing of specimens per study specific protocol.
- Performed electrocardiogram, pulmonary function tests, allergen skin tests, vaccinations and buccal swabs.
Clinical Research Assistant - Minneapolis Heart Institute Foundation - Minneapolis, MN USA
(2012-07 - 2013-01)
- Performed phlebotomy and processing of specimens per study specific protocol.
- Performed electrocardiogram and 6-minute walk tests.
- Obtained vital signs on patients.
- Collected and recorded study data.
- Input clinical data information into electronic databases.
- Ensured accurate and complete compilation of subject data through chart reviews.
- Prepared for monitoring visits.
Clinical Research Assistant - Clinical Research Institute Inc. - Minneapolis, MN USA
(2009-01 - 2012-07)
- Recruited patients for research studies.
- Performed phlebotomy and processing of specimens per study specific protocol.
- Performed electrocardiogram, pulmonary function tests, allergen skin tests, vaccinations/injections and buccal swabs.
- Obtained vital signs on study patients.
- Collected and recorded study data.
- Input information into clinical electronic databases.
- Ensured accurate and complete compilation of subject data through chart reviews.
- Prepared for monitoring visits.
- Assisted coordinators and physicians.
- Performed various administrative duties such as scheduling appointments, data base searches, confirmation letters, organizing clinic supplies and answering phone calls.
