Janice Hawkins

• Performs dashboard surveillance on multiple studies utilizing the KRI dashboard, CTMS, EDC, Lab portals, eTMF, and other reporting tools as needed. A report is preparing according to the frequency that is dictated in the clinical monitoring plan and provided to the sponsor or internally.
• Study level reports including trends and signals from sites that are trending in the high-risk category in addition to subject status, protocol deviations, AE/SAE reporting, open issues, data entry concerns, and other focus areas as needed.
• Performs remote qualification, site initiation, interim site monitoring calls, and close-out visits ensures regulatory, ICH-GCP and protocol compliance.
• Assesses the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and CMP/SMP.
• Mentor and reviews visit reports for junior level CRA/CMA's.
• Performs clinical trial management related task on multiple projects in collaboration with the project manager.
• TMF audit of regulatory files on a quarterly basis or as needed.
• Liaison between site CRO, and Sponsor regarding ICF template review and approval of language and compensation.
• Participate and contribute data to project teams, sponsors, for all internal and external meetings.

• Conduct remote monitoring visits, (including qualification, initiation, and termination visits), as needed using CTMS, Safety, IWRS and EDC study systems.
• Train and prepare sites for on-site visits.
• Act as Syneos' primary contact with 32 assigned clinical sites, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites.
• Prepare and collect high quality site documents, such as essential regulatory documents.
• Collaborate and involve Clinical Trial Specialists (CTS), on CSA (including budget), and site specific ICF negotiations.
• Collaborate with CTS and other project team members regarding on site issues/actions and provide recommendations regarding site-specific actions and use judgment and experience to assess the the ability and motivation of site staff.
• Observe/recognize trends and training deficiencies in site staff and re-train them on study specific tasks/procedures remotely as required.
• Ensure timely resolution and closure of all site issues (including Central File QC findings).
• Escalate any site and study issues that require immediate action to the Project Lead.
• Prioritized tasks to meet tight deadlines, pitching in to assist others with project duties.
• Escalate any site and study issues that require immediate
• Build relationship with investigators and site staff both remotely and onsite.
• Generate contact reports in accordance with departmental timelines and/or sponsor timelines whichever is shorter.
• Attend study investigator meetings and team builder events.
• Increased customer satisfaction by resolving complex issues and providing exceptional service at all times.

• Clinical sites main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial.

• Oversees conduct of trial at designated sites to ensure rights and well-being of subjects are protected.

• Ensures quality and integrity of the data, and ensures the sites are in compliance with protocol, study requirements, GCP and applicable regulatory requirements. Conducts Qualification, Initiation, Interim Monitoring, and Close-Out visits, and generates contact and site visit reports in compliance with the monitoring plan.

• Ensure timely and accurate access and updates of applicable trial management systems and trial master file documents. Assesses & manages test article/study supply including supply, accountability and destruction/return status.

• Reviews site recruitment plans and takes action to drive recruitment in collaboration with the site staff on an ongoing basis.

• Reviews and follows up regarding site payments. Maintains sound working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training.

• Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.

• Takes initiative to drive quality and deliverables across study team and supports Clinical Operations Lead (as requested).

• Acts as mentor. Participates in department initiatives to support process improvement and awareness (as requested)

• Managing/coordinating/supporting clinical monitoring activities remotely, including issue resolution, patient enrollment management, handling protocol- and/or ICF- and/or contract amendments, drug/supply management and ensuring timely data entry at a site level

• Data Entry as pertaining to collection and submission of study/site specific documentation.

• Awareness and capability to manage usage of Clinical Trial Management Systems, EDMS, EDC, IWRS, MS-Office products such as Excel, Word

• Strong awareness of all relevant regulations, including GCP, sponsor SOPs, etc

• Willingness and capable of displaying leadership as requested by management team, not limited to COLs, and inclusive of Line Managers

• Be a team player, including but not limited to actively supporting sponsor driven goals; meeting timelines; etc

• Mentorship- Provide assistance to any PAREXEL staff member as requested by LM.

• Conducted and facilitate specific start-up activities such as Site Regulatory Package (SRP) collection, Clinical Site Agreement (CSA) & Informed Consent Form (ICF) negotiation, and all supporting site management activities to ensure timely site initiation.

• Performed all clinical monitoring tasks and/or remote visits, applying expertise and independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines ensuring patient safety and data integrity at all times. Act as a PAREXEL remote contact with assigned clinical sites and use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites. This includes managing/supporting site activities remotely, resolving site issues, and ensuring timely/high quality data entry at a site level.

• Applied working knowledge and judgment to identify and evaluate potential data quality issues. Determined and implemented appropriate follow-up response.

• Ensured timely resolution and closure of all site issues (including Central File QC findings).

• Collected updated/amended regulatory documents in collaboration with CRA and CTS as needed

• Provided collected documents to ROA for coding, scanning, and uploading to WIP/sending to study mailbox, where possible

• Completed routine departmental administrative tasks in an accurate and timely manner (e.g. timesheets, metrics, etc.)

• Proactively kept manager informed about work progress and any issues (including conflicting priorities and free capacity).

• Maintained a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements, as well as study specific procedures and training

• Ensured basic understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery

• Updated all appropriate Clinical Trial Management Systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files as per Central File Maintenance Plan

• Escalated any site and study issues that require immediate action to the FL

• Proactively worked with other project team member and prioritize multiple tasks to meet project goals

• Delegated administrative and other tasks to ROAs as needed. Guide and mentor Research Operations Assistant, review work, and provide feedback to manager regarding performance.

• Showed commitment and perform consistent high quality work.

Contract and Budget Management Negotiation Activities:

• Experience in preparation and negotiation of Clinical Site Agreements (CSAs) on a site level with US, Puerto Rico and Canadian sites for Phase II-IV.

• Contract terms addressed in the negotiation are Publication, Privacy, Insurance, Drug Warranty, Confidentiality, Indemnification, Intellectual Properties, Subject Injuries, synopsis of general clauses and Budget or budget schedule; and Letter of Indemnifications (LOIs).

• Tracked and ensure execution of all site and investigator site agreements, distribution and proper documentation

• Ensured study timelines are met by collaboratively working with the clinical study team

• Documented collection and distribution to approved recipients.

• Provided guidance to study site staff to resolve contract or document issues and updates to appropriate team members

• Managed multiple research studies simultaneously

• Effectively combined work responsibilities to CTS 1 to meet Contract Focused objectives

• Acted as the primary CSA site contact

• Assisted with start-up activities that may include site identification, feasibility, essential document collection and review. Also assist in building business relationships with investigator/ sites and/or clinical research personnel for the conducting of clinical trials.

• Responsibilities include assisting team members with site pre-qualification activities, document collection and distribution to pre-selected sites.

• Prepared documents by using the Central Files Naming Convention for central files and uploading to PMED. Perform study related tasks using Impact Harmony systems.

• Updated contacts and site entries in IH. Assist in processes to help team meet deliverables. Specific start-up activities that may include site identification, feasibility, essential document collection and review.

• Provided assistance to study site staff updating trackers, attend team meetings and provide updates as requested in team meetings.

• Assisted team members with conducting feasibility and site pre-qualification activities, document collection and distribution to pre-selected sites, prepare documents by using the Central Files Naming Convention for central files and uploading to PMED.

• Performed random tasks using Impact Harmony systems.

• Performed administrative duties for contract team, as well as SSU team/unit.

• Assisted with coding and other process for deliverables.

• Provided assistance to study site staff updating trackers, attend team meetings and provide updates as requested in team meetings, CCT entries, and site entries in Impact Harmony.

NON-SITE FACING CTS EXPERIENCE:

• Performed document review, and provide feedback to the COL, PL, and the site via emails, teleconferencing and telephone communication.

• Limited Document collection and review of investigator site regulatory package documents, pre- population of SRP documents and feasibility.

• Reviewed ICF forms for accuracy

• Prepared and submit responsive and non-responsive letters for study sites

• Performed IH duties, such as, site updates, personnel updates, contacts, etc.

• Provided support for team to resolve contract or document issues and provide status updates to appropriate team members.

• Ensured project tracking is current and accurate to meet the project related timelines and contractual obligations.

• Complete data entry for Clinical Cost Tracking to ensure that payments to be processed.

• Prioritize daily tasks to ensure timelines are met

• Worked with Contract Manager to ensure CDA, CSA, or other mutual agreements are accurate.