Renee Langan Email & Phone Number

New York City Metropolitan Area

Tarrytown, New York, United States

Greater New York City Area

Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings• Collates data for assessments such as feasibility, site selection and review site usability database• Reviews study documents such as informed consent forms, monitoring visit reports and facilitates study document reviews per company standard operating procedures (SOPs)• Maintains study systems including CTMS and TMF• Constructs and organizes materials for trainings and investigator meetings as well as participation and execution• Tracks site activation, enrollment and monitoring visit projected plans and escalates any issues or delays with site activation or deviations from monitoring plan to management• Performs scheduled reconciliations of study TMF• Manages and maintains team SharePoint, distribution lists and/or shared drive sites, as needed• Supports data quality including regular review of open queries and protocol deviations• Manages and contributes to the oversight of vendors and escalates issues to the Clinical Study Lead • Provides regular status reports to key stakeholders as requested by Clinical Study Lead• Reviews and collates procedural documents list of Standard Operating Procedures (SOPs) • Creates and provides input for the development of site-facing study specific forms and checklists• Mentoring clinical trial management staff• Sustains budget management process and maintains/updates the study budget worksheet • Submits suspected serious non-compliances (SSNs) and participates in quality management reviews• Adapts to the needs of management when team representation is crucial at meetings• Contributes to risk assessments and helps identify potential risks and mitigations• Supervises and participates in the planning and management of a clinical study in an assigned region• Knowledgeable in study start-up activities; country regulatory requirements and ICH/GCP

Tarrytown, Ny

• Participates in Clinical Study team meetings for one or more clinical studies• Assists in the writing, collection, distribution and filing of meeting agenda and meeting minutes• Supports the scheduling and coordination of project team meetings and minutes• Assists with request, collecting and reviewing site regulatory documents• Tracks site study start up status and activities using established study tools• Support maintenance and reconciliation (QC) of essential study documents and electronic Trial Mater File (eTMF) according to TMF plan• Collates and assembles study documents under guidance of the study specialist or manager for: study binders (regulatory, pharmacy, laboratory), study reference manuals, CRA training and Investigator Meeting materials, and study data collection tools• Maintains team SharePoint and/or shared drive sites as needed• Uses judgement to escalate issues to the appropriate team members for consideration and resolution• Applies knowledge of company policies and standard practices to resolve problems• Works with other internal departments to provide and receive required information for achievement of Clinical Research assignments, goals and objectives• Schedules and coordinates meetings• Collates materials for training and investigator meetings• Updates investigator/site status for the trial• Ensures scheduled reports are received (i.e. FDA Form 1572 reportable changes, financial disclosure form status)

Greater New York City Area

•Perform sample management activities in his/her assigned area; Functions could include populating LIMS database to create studies based on protocols/supporting documents, accessioning pre-clinical/clinical samples, verifying data, and assisting in preparation of supporting documents for QA audit. • Perform LIMS data entry/review and maintain documentation. • Follow established procedures to process sample management activities accurately and within the required timeframe. • Maintain accurate and complete safety records consistent with company policy and legal requirements. Recognize potential safety problems and either proactively takes action or informs supervisor in order that appropriate action may be taken.

White Plains

• Provide graphics, specs and art sizing for electronic and print media• Collaborate with the Marketing team to design and produce computer-generated artwork and promotional materials• Convert files for album covers, HEPM images and catalog covers• Textbook cover branding, badging and custom printing• Performed minor page layout modifications and reprint corrections• Coordinate projects with outside vendors

• Interact with Editorial staff and Authors to provide administrative support• Edit student and teacher manuscript materials• Prepare, track and manage payments and royalty advances for Authors, freelancers and reviewers• Coordinate reprint corrections• Maintain title and ISBN data using editorial databases• Create, develop and run domestic and international sales reports

• Accession, label and prepare specimens for grossing• Identify and sort processed tissue• Tissue embedding• Cut tissue sections for slide preparation• Perform “immuno”, “special” and “routine” staining of slides and mount protective cover slip• Prepare patient fluid samples for cytological analysis• Assist with the collection of fine needle aspirations• Use of “Meditech” software to archive patient data• Abide by the New York State Health Department biohazard and safety procedures• Perform equipment maintenance