Jessie Downs

· Support department and/or department leadership with daily clerical tasks.

· Collect, reviews, analyze complex and/or confidential data, and prepares reports, charts, budgets, and other presentation materials.

· Respond to or routes non-routine, priority, or confidential inquiries from external or internal sources with correspondence or other messaging on behalf of department leadership.

· Plan meetings and take detailed notes, as needed.

· Answer phone calls, provide information to callers, or connects callers to appropriate staff.

· Schedule appointments and updates calendars.

· Make travel arrangements and reservations for department leadership and staff, as needed.

· Compose and type correspondence, such as informative materials; creates spreadsheets and presentations.

· Greet and provide general support to visitors.

· Develop and maintain department filing system.

· Assist Lab Director with reviewing records for research lab billing, prepare invoicing, Journal/BJF submissions.

· Respond to client and sponsor inquiries, such as queries.

· Create Standing Purchase Orders (PO’s) and basic POs for lab related needs, receive lab inventory, organizes supplies and places orders for supplies.

· Track Lab equipment for service needs and maintains maintenance records including temperature logs and calibrations.

· Assist Lab Director with regulatory documentation such as lab certifications (CLIA and CAP).

· Assist Lab Director with Lab Personnel training compliance and certification records.

• Serve as the liaison with study coordinators to ensure lab kits are prepared and delivered.
• Assist Lab Director with reviewing records for research lab billing, prepare invoicing, ISD/Journal submissions.
• Respond to client and sponsor inquiries.
• Manage Lab Manuals and update when protocols are modified.
• Inputs requisitions, check requests for SCCC Research Lab related purchases.
• Create Standing Purchase Orders (PO’s) and basic PO’s for lab related needs, receives lab inventory, organizes supplies and places orders for supplies
• Answer Lab phones and direct calls to minimize interruption of Lab operations.
• Track Lab equipment for service needs and maintains maintenance records including temperature logs and calibrations.
• Review daily lab requisition forms and uploads to electronic study file.
• Assist Lab Director with regulatory documentation such as lab certifications (CLIA and CAP).
• Assist Lab Director with Lab Personnel training compliance and certification records.
• Assist Lab Director and Lab Supervisor with Lab budget development and tracking of expenditures.
• Prepares daily delivery confirmation reports and shares confirmation information with study team Point of contact and files report in study file.
• Assists in the development and updating of Lab Policy & Procedure.
• Coordinates with Phlebotomy for daily schedule.
• Assists in preparation of leadership reports as needed.
• Enter receipt of lab samples into specimen tracking system and updates databases as needed.
• Verify the sample information is consistent with Lab Requisition Form and ensures chain of custody has been followed.
• Process samples based upon protocol and lab manual requirements
• Prepare samples for transport, shipping, short-term or long-term storage.
• Complete required research sample paperwork to be sent with samples and for uploading to research files.
• Participate in Site Initiation Visits (SIV) as needed with sponsors.
• Recognize and apply requirements for all research lab supported protocols and lab manuals.
• Report protocol deviations to Lab Supervisor, Lab Director and/or study team as needed.
• Assist in daily cleaning of lab space and ensure compliance with lab regulatory guidelines.
• Able to manages high volume of workload with accuracy and efficiency.

• Involved in the subjects screening and enrollment for the clinical studies.
• Coordinated with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures.
• Prepared and maintained clinical trial source documents.
• Engaging with subjects and understanding their concerns.
• Conducted study visits, including vital signs and ECG.
• Completed and ensured the quality of case report forms.
• Maintained documentation regarding all aspects of the study.
• Reviewed CRFs and resolved data discrepancies/queries.
• Reviewed current eCRFs guidelines for each Clinical Trial.
• Communicated with Sponsor representatives to effectively address any discrepancies that may arise during the trial.

• Involved in the subjects screening and enrollment for the clinical studies.
• Prepared and maintained clinical trial source documents.
• Conducted study visits, including vital signs and ECG.
• Completed and ensured the quality of case report forms.
• Maintained documentation regarding all aspects of the study.
• Maintained patient confidence by keeping information confidential.
• Experienced in interpreting medical charts and abstracting data from medical records.
• Reviewed current eCRFs guidelines for each clinical trial.
• Maintained accuracy and quality throughout a clinical study.

• Scheduled, rescheduled and canceled appointments on an everyday basis.
• Maintained doctor calendar schedule.
• Greeted patients, visitors and answered multiple telephone calls in a prompt and courteous manner.
• Performed various secretarial/clerical duties such as documenting, photocopying, faxing, scanning and mailing.
• Filed, organized and maintained patient medical records.
• Coordinate transportation for patients on a daily basis.

• Assisted the Vice Chairman of the Department of Medicine with scheduling meeting appointments, conferences, and events on an everyday basis.
• Provide customer service to faculty and staff and non-University vendors and agencies by resolving current and potential issues, such as orders and requisitions.
• Ensuring office procedures and systems operate efficiently.
• Performed various secretarial/clerical duties such as documenting, photocopying, faxing, mailing, and organizing filing system.
• Purchased office equipment and supplies - contacted vendors and subcontractors.

• Meeting Data Entry requirements/expectations set forth by Sponsor
• Review of current eCRFs guidelines for each Clinical Trial
• eCRF completions, query resolution, discuss protocol and Data Entry requirements with study coordinator prior to study commencement
• Actively manage workflow to ensure Data Entry objectives are achieved
• Communicate with Research Coordinator and Sponsor representatives to effectively address any discrepancies that may arise during the trial
• Assist Quality Assurance Department in identifying potential issues during the conduct of a Clinical Trial

• Assist with pre-award proposal development, including meeting with Principal Investigators to prepare budgets, internal University forms such as Proposal Transmittal, Financial Interest
• Disclosure (FID), Cost Share, Overhead waivers, and required grant application forms for federal and non-federal funding agencies. Initiate and prepares federal government proposals on Infoed system
• Assist with post-award processes, including purchase order requisitions (POs), interdepartmental requisitions (IDRs), business expense reimbursements (eBERFs), and check requisitions for study participants, memberships, and meeting registrations (eCheck), prepare journal entries
• Monitor Accounts Payable (A/P) for all invoices, including University-authorized vendors and interdepartmental services
• Provide customer service to faculty and staff and non-University vendors and agencies by resolving current and potential issues in pre and post-award processes, such as proposal development and orders and requisitions
• Assist with IRB data entry in the Human Subject Research Office (HSRO