Melisa Soland M.Sc., Ph.D. Email & Phone Number

Mainz, Rhineland-Palatinate, De

King Of Prussia, Pa, Us

The Clinical Scientist (CS) assists the clinical study team with the clinical/scientific conduct of clinical studies (e.g. adjudication support, medical monitoring, imaging data reconciliation, preparation of meeting materials, and protocol deviation management).• Responsible for the scientific execution of two oncology (Phases II and III) clinical trials.• Clinical point of contact for scientific issues, questions, and input for the clinical operations team and external stakeholders.• Author of clinical, scientific, and regulatory documents with the medical writer, such as Protocols/amendments, site monitoring plan, procedure document, pharmacy manual, informed consent, and protocol deviation list.• Support data management activities: subject eligibility, protocol deviation, reconciliations of lab and biomarker samples, scans, and ECGs, review of lab and SAE reports, and other external data for safety and critical values. Monitor data issues and trends, that require clinical and scientific input, and prepare for medical monitoring meetings.• Collaborate with study managers and the clinical trial team on study deliverables as a member of the clinical operations team.• Provide clinical specifications to external vendors and support vendor management such as Bioclinica, Q2 Solutions, Medidata (e.g., IVRS, planning of laboratory, bio specimens, and imaging specifications).• Prepare scientific slides and present protocol information at Investigator Meetings.

Wilmington, Nc, Us

• Phase 2 and 3, adaptive studies, for the development of vaccines and therapies to counter COVID-19, project funded by the US government and pharmaceutical companies Brii Biosciences, Eli Lilly, AstraZeneca (Operation Warp Speed).• Liaise between the sponsor, medical expert monitors, and investigators to reach project goals and deliverables.• Conduct regularly protocol specific training, site management calls, compliance monitoring, and business correspondence with investigators to support the sites’ execution of their study responsibilities in accordance with project scope, study communication, monitoring plan, and ICH/GCP guidelines, and timelines.• Serve as the primary study contact for sites during initiation, conduct, and close-out visits.• Assist sites with ad hoc site requests, related to clinical/medical aspects of the protocol and CRF among other documents, issues with the vendors and systems such as CTMS and IVRS, resolution of outstanding clinical data queries, reporting of adverse events according to Safety Review Plan, and database locking to maximize the efficiency and quality of the trial.• Manage site and subject IP accountability, chain of custody, temperature logs, and IP shipment and return.• Assess Key Risk Indicators, mitigates risk, and implement corrective action plans in the presence of a risk. • Reconcile invoices, laboratory imaging files, laboratory sampling, deviations of protocol, and patient data recorded in Oracle Clinical Trial Management System for sites located in USA and Canada.• File essential documents and communication notes to Trial Master File and ensure compliance.

Wilmington, Nc, Us

• Phase 1 and 2 studies of combined cancer immunotherapies for the treatment of patients with locally advanced or metastatic solid tumors by assessing safety, immunogenicity, Progression-Free Survival, Overall Survival, Time to Tumor Response and Duration of Response according to RECIST, and Tumor tissue biomarkers.• Perform all aspects of in-house site management together with CRAs, and in accordance with good clinical practices • Conduct regularly scheduled site management calls with study sites to support the sites’ execution of their study responsibilities• Document and help follow to resolution, issues noted during site management contacts• Escalate to management any observed deficiencies or issues in a timely manner and in accordance with study communication and monitoring plan guidelines• Serve as the primary study contact for sites during initiation visits, periodic monitoring visits, and close-out visits.• Liaise between the sponsor, medical monitors and KOLs • Respond to ad hoc site requests for assistance• Assist sites with the resolution of outstanding data queries during the study and database locking• Provide ongoing site training • File documents to eTMF.• Ensure study systems are updated per agreed study conventions (e.g., Oracle Clinical Trial Management System – CTMS) to ensure adequate communication to project team and sponsor• Play an active role within the clinical team to help reach project goals, achieve deliverables, and meet project timelines

Wilmington, Nc, Us

• Leader of a group of four SRAs in safety report processing for serious adverse events for the largest study.• Subject matter expert in supporting PVG department with the report of NCQEs. • Lead projects, provide assistance and direction to team members and liase with clinical and PVG departments.• Review of patient narratives.• Train new personnel on safety reporting processes and procedures.• Ensure regulatory submission files and filing processes are prepared, set up, maintained and archived.• Provide safety and administrative support to the PVG Department to maintain compliance. • Entry of initial and follow-up serious adverse events data, and update tracking systems and safety databases. • Collect, prepare, evaluate the quality (QC), file and archive expedited and periodic safety reports.• Review safety information (SAE) and data entry of safety narrative from CIOMS forms to databases.• Attended the PPD clinical foundation program, to gain the competencies expected of a PPD monitor, such as monitoring plan and roles, risk-based monitoring, informed consent, remote data review and site management calls.

Mumbai, Maharashtra, In

Edit, proofread, and format manuscripts, abstracts and presentations, in topics related to life, medical, and pharmaceutical sciences, for non-native English-speaking clients.

Mumbai, Maharashtra, In

Freelancer for Spanish-English translation services for manuscripts, abstracts and presentations of life and medical sciences.

Chicago, Illinois, Us

New York, Ny, Us

Chapel Hill, Nc, Us

• Participated in the start-up and kick-off meeting of the Phase III MOMPOD study (Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy).• Participated in the observational HCHS/SOL (Hispanic Community Health Study / Study of Latinos) study and its ancillary sub-studies, which identifies factors playing a protective or harmful role in the health of Hispanics/Latinos.• Reviewed, wrote, collected and edited study documentations, including protocol, manual, informed consent, clinical case study reports, such as for adverse events and SAE, and paper and electronic case report forms.• Created, tested and validated electronic forms in the Electronic clinical data capture systems EDC system: CDART. Used this data management system for electronic data capture, real-time electronic case reports, queries and data extraction in standard formats.• Participated in meetings with KOLs, coordinators, CRAs, IRB, pharmacy and DSMB.• Knowledge of ICH/GCP regulations.

Chapel Hill, Nc, Us

• Participate in an Observational Study of Postoperative Deep Venous Thrombosis (DVT) in Hemophilics Undergoing Major Orthopedic Surgery.• Manage and analyze data by using Red Cap system (quality control).• Identified missing, incorrect, and duplicate data, and submit queries to the clinical sites.

Chapel Hill, Nc, Us

• Develop a gene therapy technology using AAV vectors for treatment of Mucopolysaccharidosis1 (MPS1)-Hurler syndrome and hemophilia using in vitro and murine models. Richard Jude Samulski laboratory. Hematology/Oncology department.

Cary, North Carolina, Us

• Participated in clinical trials for drugs and biologics to treat the pediatric population.• Reviewed of SOPs, and wrote and edited regulatory documents, including pre-IND, IND, OMPD (orphan drug designation), and SPA (Special Protocol Assessment) to support pediatric clinical trials.• Wrote letters for requesting type B and C meetings to the FDA. • Set up meetings and prepare agendas.

Durham, North Carolina, Us

• Reviewed pre-IND, IND, and BLA submissions for Duke Hospital. • Learnt about FDA guidance for industry and regulatory life cycle of small molecules and biological products.

Winston-Salem, Nc, Us

Post-doctoral Research Fellow. Management and maintenance of Almeida-Porada and Porada laboratories since their beginning in 2011 at WFIRM. Responsible for overseeing, reorganizing and training graduate and undergraduate students in cellular and molecular biology techniques, general good laboratory practices and bioethics. Conduct research in several projects, multitask and perform groundbreaking scientific discoveries. • Developed stem cell therapies for treatment of inflammatory bowel disease, psoriasis an diabetes using in vitro and murine models.• Studied the role of the bone marrow microenvironment (MSC and HSC) in space radiation. • Investigated the best cellular vehicle to deliver FVIII to the appropriate tissues in the body for treatment of Hemophilia A by gene therapy. • Developed lentiviral/retroviral systems that will support increased levels of Factor VIII production for lifelong correction of Hemophilia A.• Studied human cytomegalovirus course of infection, transmission, immune evasion and potential reservoirs.• Served as a Peer Reviewer for manuscripts that are submitted to PlosOne journal.

Reno, Nv, Us

Research Assistant, Cellular and Molecular Biology. Performed independent research in several fields. Participated in discussions of new techniques and groundbreaking scientific discoveries across multiple disciplines as well as in national and international meetings. • Design and conduct in vitro and in vivo laboratory experiments evaluating immunological responses to progenitor stem cells. • Use sheep as the animal model for bone marrow transplantation studies.• Study variant pathogenicity of UL18 human cytomegalovirus gene.

Ar

• Designed and performed in vitro assays to evaluate genetic polymorphisms associated with high plasma triglyceride levels in patients with type 2 diabetes.

Ar

• Managed and trained graduate students during chemistry and molecular biology classes, in problems-solving skills as well as in practical techniques.

Phd, Cellular And Molecular Biology, University Of Nevada Reno, Reno, Nv

Clinical Trials Research Associate Certificate

Master, Biotechnology, Universidad Nacional De Rosario, Rosario, Argentina

Regulatory Affairs

Certificate, Clinical Development

Cna Certificate, Senior Health Care

Clinical Data Management Certificate