Christopher Rowland Email & Phone Number

Mooresville, Nc, Us

Charlotte, North Carolina, United States

FSP at Amgen Participate in study planning and set-up activities including vendor management, project management and the coordination of study and implementation plansAssist in monitoring the execution of the clinical study deliverables against the specified timelines,deliverables, and budget as delegated by the GCTM/GECDMContribute to or coordinate preparation and conduct of site initiations, monitors’ workshops (asapplicable) and investigator meetings (as applicable)Coordinate study-level Investigational Product arrangements, accountability and reconciliationManage the process for planning and procuring ancillary clinical supplies, including collaboration with BSM and assay groups to coordinate shipment and analysis of clinical biological samplesWork with the GCTM/GECDM, LTM and RCTM to develop recruitment strategiesMonitor the progress of studies, data flow, identifying study related trends/issues and working with the GCTM/GECDM to implement corrective actions when necessaryCreate and manage study specific tools such as recruitment and retention materials and studynewslettersContribute to and support with the preparation, writing and review of study related documentsincluding but not limited to: study guides, monitoring plans, e(CRF)s, Investigational ProductInformation Manual (IPIM), study specific Important Protocol Deviation (IPD) list,subject information sheets, clinical study report, regulatory submissions and publicationsParticipate in Line Listing ReviewSupport and oversee vendor activities and relationships where assignedCompile IRB/EC submission documentationAssist with Global Development Operations (GDO) Operational Review preparationManage global versioning and distribution of informed consent forms (ICFs)Support inspection readiness activities (e.g. Study History Document / TMF maintenance and review)Work with outsourced vendors to organize and deliver essential documents to the trial master file

Mooresville, North Carolina, United States

Morrisville, North Carolina, United States

Clinical Project Associate at Gilead Sciences:Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systemsAttends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings)Follows up with team members on action items to closureMaintains timely and effective communication among team members and site staffKeeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study statusContact site staff as needed for critical informationProvide administrative support to Project Leads and functional leadsEnsure all study documents are archived based on the appropriate guidelines and policyProvide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues

United States

Verifying and/or correcting research study information on source documents; researching queries and variances; providing feedback to the site data collectorAccurate input of trial data into the Electronic Data Capture (EDC) system and tracking visits and procedures completed against budget in the clinical trial management system (CTMS)Preparing and maintaining study files, and timely submission of informationCollecting, submitting and assisting in maintaining relevant regulatory and ethics documentsScheduling visits with research subjects, generating appropriate reports and documentationProcessing lab specimens, labelling vials, accurately filling out requisitions for storage and/or shipment per study protocol and shipment regulationsOther administrative support functions such as reception, office organization and supply management

Charlotte, North Carolina, United States

Identification, screening, randomization, and enrollment of patients in IRB approved clinical trial protocols.Complete all trial related procedures, including clinic visits, etc., according to each individual IRB approved clinical trial protocol, established Standard Operating Procedures (SOPs), Sponsor specifications and Good Clinical Practice (GCP).Ability to perform direct patient care activities such as consenting patients, physical assessments, blood draws, medication administration, ECG, etc.Building and maintaining excellent communication with Principal Investigators and others needed to conduct quality research to foster an excellent reputation of site research.Ensure efficient monitoring of all trials by ensuring that the data is clean and entered accurately into the sponsor EDC in a timely fashion.Supervise site initiation activities as well as oversee the set-up and maintenance of studies.Create and submit Regulatory and associating documents as needed to start new clinical trials.Maintain both new and ongoing IRB processes.Revise IRB submissions in response to identified problems and resolve issues in a timely manner.Create and maintain up-to-date Source Documents (paper and electronic) for each study.Review audit findings from the medical monitor and/or internal auditor and discuss with Associate Site Director and/or other Executives when needed.Tracks and obtains knowledge to observe and report adverse/serious adverse events, protocol violations/deviations in a timely and accurate manner.Attend all clinical operations meetings and conduct strategic planning as needed.Attend Investigator meetings and training sessions as needed. This may require occasional out-of-town travel.

Wilmington, North Carolina, United States

Work in a dynamic and fast paced environmentUtilize a variety of software tools to navigate and research customer accounts, and communicate effective solutions in a team based environmentReview documents such as immunization records, drug test results, and certifications to ensure compliance with guidelinesProvide students with essential feedback, while meeting review goals and accuracy expectationsReview client submissions to ensure they meet all set guidelinesPerform re reviews, and work with auditors to ensure accuracyCommunicate with users to give feedback on submissions, and improvement

Wilmington, North Carolina, United States

In their Psychology Department, Public Health and Drugs LaboratoryConduct literature reviewsCollect and analyze dataReview materials for submission to granting agencies and foundationsReview materials for Human Subjects Committee reviewPrepare interview questionsRecruit and/or interview subjectsMaintain accurate records of interviews, safeguarding the confidentiality of subjects, as necessarySummarize interviewsProvide ready access to all experimental data for the faculty researcher and/or supervisorManage and respond to project related emailPrepare, maintain, and update online surveysAttend project meetingsAttend area seminars and other meetings as necessarySummarize project resultsPrepare other articles, reports, and presentations

Cherokee, North Carolina, United States

Master'S Degree, Public Health - Leadership In Practice

Bachelor'S Degree, Psychology

Associate Of Arts - Aa, General Studies