Holly Harrison, Ccrp Email & Phone Number

Houston, Texas, United States

-Responsible for all necessary operational activities required to plan, implement, execute, and report on a clinical study.-Develops and maintains clinical study protocols, Informed Consent Form (ICF) templates, project plans, budgets, contracts, training manuals, and other related study documents.-Serve as the company's clinical representative in interactions with clinical consultants, Contract Research Organizations (CROs), study sites, and other vendors.

Houston, Texas, United States

-Served as a clinical point person to manage protocol execution for a majority of open to enrollment (registries, non-treatment, roll over, phase I-IV) and limited number of closed to enrollment studies. -Accountable for study start-up activities, timeline management, organization, administration, and execution of the clinical trial from start to finish in compliance with GCP, IHC, SOPs, internal/departmental guidelines.-Primary contact for sponsors/CRO and vendors. Primary contact for the Network PI and Local PI’s.-Reviewed and submitted sponsor documents and amendments to the appropriate regulatory personnel for processing and IRB review-Anticipated and identified potential issues and created contingency plans-Worked collaboratively with individuals cross-functionally across the organization and provided clear direction and timelines for supporting members of the project (budget, contracts, regulatory, pricing, & network operations).-Ensured all trial deliverables were met according to timeline, budget, and resource requirements. -Identified, addressed, escalated and communicated quality and compliance concerns.

Houston, Texas, United States

-Managed clinical trials with low numbers of active patients and patients in follow up that are closed to enrollment and assisted with preparing them for study close out.-Communicated with sponsors, CROs, and sites as the primary point of contact for the study for any issues related to the protocol, study conduct, billing, monitoring, or information found in USOR’s CTMS system.-Reviewed and submitted amendments to the appropriate regulatory personnel for processing and IRB review.-Worked internally across departments to clear any outstanding issues such as queries, payments/billing, and regulatory documents so that studies may be closed.-Organized and created materials to present point topics for USOR committee meetings.-Mentored and trained newly hired Sr. CTAs to ensure they understood specific job responsibilities and became familiar with USOR central processes and systems.

Houston, Texas Area

-Fulfilled all job responsibilities as a Research Data Coordinator in addition to mentoring new hires to teach all position requirements and technical training.-Maintained a leadership role within the team to serve as an information resource for other data coordinators.

Houston, Texas Area

-Assisted in the coordination of regulatory correspondence and protocol administration on all departmental clinical research for Phase I clinical trials in oncology.-Assisted study team with patient related activities -Reviewed medical records to extract data points and transferred patient information into electronic databases and case report forms (CRFs)-Extensive Electronic Data Capture (EDC) experience and management including Medidata/RAVE, Oracle Inform, OC-RDC, and other proprietary EDC systems. -Assisted in the development and maintenance of an organizational system to coordinate research meetings and research deadlines and inform staff as needed-Adhered to policies and procedures related to conduct of clinical trials as delineated in departmental manual and training programs-Acted as a liaison between sponsors, monitors/auditors, and the clinical study team to maintain accurate conduct of trial and resolve any discrepancies-Experience with HIPAA compliance, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and Human Subjects Protection Training (HSPT). -NCI/CTEP registration with an Associate Plus role.

Bryan/College Station, Texas Area

Comparative quantitative analysis of larval salamander head morphology as it relates to their trophic ecology. Morphometric measurements were collected for over 400 specimens. Statistical analysis was employed to ascertain the degree to which the species and lineages were similar morphologically and how that relates to their distribution throughout the landscape. The project was designed to demonstrate that coexisting species exhibit differences in head morphology to reduce direct competition by allowing them to utilize different microhabitats.

Bryan/College Station, Texas Area

-Created a peer-facilitated learning environment that provided academic assistance to improve students' performance in class.-Lead an upper level interdisciplinary undergraduate biology course called Genes, Ecology, and Evolution. -Attended lecture and lead three one hour review sessions each week. -Created worksheets and exam reviews for students to use as study tools as well as a social media page where students could ask questions and have access to all of my course materials.