Casey Eckman Email & Phone Number

Lancaster, Pa, Us

Cambridge, Ma, Us

Develop and implement regional feasibility plans for first-in-human, early-phase and late-phase oncology trials in the US and Canada.Engage sites during feasibility to efficiently execute CDA’s and collect key information to support site identification and selection; Liaise with internal stakeholders (ex: CSMs, FMDs and CRAs) as needed.Utilize expertise of therapeutic area and site operations to provide strategic recommendations to teams on potential first site(s) to be selected/activated to achieve FPI.Collaborate with site partnership team and Field Medical Directors to identify key sites and investigators, engaging early in feasibility and throughout the life of the trial.

Dublin, Ie

Managed start-up activities for assigned studies at the regional level including supporting site identification/site recruitment/site selection in feasibility, central and local submissions, site contracts, essential document preparation, Investigational Product (IP) release, site initiation visits (SIVs) readiness, and overall regional site activation readiness to ensure deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations.Collaborated with the project team in creation and execution of sponsor and cross-functional team communications, identifying risks with mitigation plans and addressing issues with corrective action and solutions.Ensured quality standards and applicable regulatory requirements are met in accordance with the protocol, applicable guidelines, and local regulations for IP release and site activations.Analyzed metrics and reports of regional performance against key performance indicators.

Independently Reviewed study data in accordance with Monitoring Plan, Site Management Plan, Data Management Plans and applicable (SOPs, etc.) to identify data trends, data inconsistencies, and erroneous, missing, incomplete, or implausible data through the aggregate review of study data by patient, site, and/or project.Performed site evaluation and recruitment including, collection and review and close out of required critical documents from sites (including submissions and notifications to Institutional Review Boards or Ethics Committees (where applicable) by creating, updating, tracking, and maintaining study specific trial management files, tools, and systems.Oversaw and maintain communications with vendors and facilitate the management of study supplies.Assisted in developing phone scripts, questionnaires, study site materials and other project specific tools.Independently managed study sites to ensure adherence to the study design and act as primary point of contact for assigned study sites retaining primary responsibility for the resolution of all site issues.

Raleigh, North Carolina, Us

Coordinated and conducted telephone PSSV, SIV, and COV visits to assess the qualification of potential study sites, to initiate and instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies.Recruited and evaluated potential sites for participation in studies. Utilizes assessment tools, questionnaires, and study site materials in evaluation of study sites.Performed essential document collection, review, maintenance and close out activities for sites participating in the Late phase study design.Monitored studies to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines.

Coordinated patient care visits according to the protocols’ schedule of events, documented visits within EDC and eSource.Collected, processed, and shipped blood specimens and reported all patient SAE’s/AE’s. Organized study files, regulatory binders, and maintained inventory of drug shipments, lab kits and excess supplies. Attended Investigator Meetings for studies in the pipeline and attended tumor board meetings.Created Standard Operating Procedures.

Woonsocket, Rhode Island, Us

Liberal Arts And Sciences/Liberal Studies

Registered Nursing/Registered Nurse

Associate Of Arts - Aa, Liberal Arts And Sciences/Liberal Studies

Health/Health Care Administration/Management