Anderson Lang Email & Phone Number

Wilmington, Nc, Us

Responsible for performing investigative site recruitment/feasibility, site project training, remote clinical data monitoring and resolution, site progress status tracking, in-house site management, documentation filing, and other duties in accordance with Sponsor and/or UBC requirements. Performs essential document collection and review for site start up and initiates in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and good documentation practices. Demonstrates ability to successfully lead and mentor CTS staff, take on high level tasks as delegated by Project Manager/Functional Manager, and escalate and mitigate risk as appropriate.

Perform remote monitoring visits for various client studies to ensure patient safety, GCP compliance and data integrity by confirming the site is conducting the study in accordance with the protocol, ICH guidelines, and applicable regulatory requirements.• Assists with investigator identification, evaluation and selection activities, as requested • Performs pre-study site visits (PSSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs) in accordance with the Task Order, protocol, study-specific monitoring plan, applicable SOPs, ICH guidelines and all applicable regulatory requirements. • Conducts source document verification, performs drug accountability and reviews the investigator site file during on-site monitoring visits as outlined in the study-specific monitoring plan• Responsible for building strong, collaborative relationship with investigators and staff at assigned clinical sites. • Collaborates with assigned sites to develop and maintain a site-specific recruitment and retention plan; responsible for regularly reviewing this plan with the site during monitoring visits and ensuring the timely implementation of contingency plans ensure recruitment goals are met • Serves as a point of contact for study-related questions and issues from study sites • Responsible for providing study-specific training to the clinical site staff • Generates confirmation letters, monitoring visit trip reports, and follow up letters in a timely manner for each monitoring visit • Generates and assists in the closure of data queries, as appropriate • Assists in the collection of follow-up data for serious adverse events, as requested • Proactively identifies, documents, and assists in the resolution of issues relating to subject recruitment, study data quality and study conduct at assigned study sites

Durham, North Carolina, United States

• Responsible for the preparation, distribution, and tracking of site regulatory start-up packages to sites • Responsible for obtaining/assembling, distributing, tracking and ensuring the return of clinical study supplies and equipment for assigned clinical studies • Responsible for performing and documenting the review of informed consent forms to ensure all required elements are present • Maintains the Trial Master File (TMF) by requesting, collecting, reviewing, tracking, and filing all essential documents throughout a clinical study • Assists the Associate Study Managers (ASM), Clinical Trial Leader (CTL), and Project Manager (PM) with various study-related activities which may include circulation of study documents for review, assisting with the organization of face-to-face meetings, prepopulating documents, and reconciling investigator payments • Responsible for updating internal and client-specific systems, as required • Maintains department and study-specific tracking documents • Coordinates and schedules meetings and teleconferences with internal and external attendees across multiple time zones; distributes agenda and produces minutes from internal and external meetings • Performs administrative tasks to support team members with clinical trial execution, as needed • Actively participates in study team’s ongoing commitment to quality and efficiency by providing feedback and possible process improvements • Other duties as assigned

Wilmington, North Carolina, United States

Bachelor Of Science - Bs, Biology

Associate Of Science - As