PRA Health Science - Senior Clinical Research Associate Dallas , TX01/2019 - Current
Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification).
Assesses investigational product through physical inventory and records review.
Documents observations in reports and letters in a timely manner using approved business writing standards.
Escalates observed deficiencies and issues to clinical management expeditiously, presents potential solutions and follows all issues through to resolution.
Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
Conducts monitoring tasks in accordance with the approved monitoring plan.
Participates in investigator meetings as necessary.
Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
Performs trial close out and retrieval of trial materials.
Manages the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and the PRA project team through written, oral and/or electronic contacts.
Responds to company, client and federal regulatory requirements/audits.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team member.
PRA Health Science - Clinical Research Associate II Dallas , TX06/2017 - 01/2019
Responsible for conducting monitoring activities at a clinical site(s) for a clinical trials.
Responsible for multiple projects and able to work both independently and in a team environment.
Ensured subject safety and verified diligence in protecting the confidentiality of each subject.
Guaranteed the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes.
Reviewed and/or inputed to study protocol, CRF and validation tools.
Participated in Investigators selection/feasibility: e.g. phone contacts, questionnaire in the appropriate country.
Conducted site qualification visits (pre-study visits).
Conducted site initiation- and site close out visits.
Conducted regular monitoring visits.
Ensured that the site was equipped with all necessary supplies for timely reporting and that the procedures (sampling storage and shipment logistics) were appropriately adhered to.
Distributed any documents collected during the monitoring visit to the appropriate department (data entry, assistants for archiving etc.)
Resolved questions/issues with investigator/trial staff including query verification.
PRA Health Science - Clincial Research Associate I Dallas , TX01/2015 - 06/2017
Resolved issues with investigative sites utilizing knowledge, expertise and problem-solving techniques.
Assisted in investigator selection and qualification process to provide capable investigators suitable for conducting study.
Reported general issues directly to management promptly for efficient problem-solving and resolutions.
Maintained awareness of current developments in areas relative to assigned projects.
Worked closely and effectively with other department personnel to communicate pertinent information and maintain study conduct.
Monitored patient safety and oversaw informed consent procedures.
Evaluated electronic data capturing systems for adherence to guidelines.
Conducted initiation, monitoring and closeout visits.
Reviewed participant eligibility and documentation of consent.
Monitored collection, accuracy and integrity of regulatory documents in site binder.