Clinical Trial Speciaist

Clinical Trial Specialist - RTP Area (Raleigh Durham), NCRequisition Code: 443Committed to Making a DifferenceTriPath Imaging, Inc. is recognized as one of the fastest growing Biotechnology companies in North Carolina. Committed to the early detection and clinical management of cancer, we are also pioneers in the field of Research and Development of Image analysis systems. We are quickly emerging as a leader in women’s health and cancer diagnostics and looking for experienced leaders and professionals to join our team.
We currently have an opening for a Clinical Trial Specialist to coordinate clinical trial activities under the general guidance of the Clinical Trial Manager and Study Director (Director of Clinical Operations/Affairs), in compliance with TriPath Imaging Standard Operating Procedures, applicable regulations and guidelines, and general industry standards. Assumes primary responsibility for specialized clinical trial operations services and participates in the development and implementation of clinical trial operations on assigned projects, as requested by the Director of Clinical Operations/Affairs.
This position will be located in Durham (RTP), NC.Responsibilities include:· Assumes the role of a general or project-specific Clinical Trial Specialist within the Clinical Operations/Affairs Department, as assigned by the Director of Clinical Operations/Affairs.· Assists the project team/Clinical Operations/Affairs Department by performing trial coordination activities and specialized clinical trial operations services (e.g., MDR event information collection, clinical trial hotline management, etc.) as requested by the Director of Clinical Operations/Affairs and Clinical Trial Manager(s). Assists with the tracking of patient enrollment data, monitoring visit data, investigator payments, CRF tracking, etc. as required to meet overall department and project goals and deadlines.
· Under the general guidance of the Director of Clinical Operations/Affairs and Clinical Trial Manager(s), interacts with external partners, including Contract Research Organization (CRO) personnel, to ensure the timely and cost-effective conduct of high quality clinical trials. When applicable, oversees the monitoring of sites by CRO personnel, maintaining direct communication with assigned CRO CRAs and reviewing trip reports and other relevant correspondence and documentation, as required to ensure the study sites’ compliance with the protocol and applicable SOPs, regulations, and guidelines.
· Performs site management activities for assigned sites to ensure compliance with the protocol, applicable SOPs, regulations, and guidelines.
· Assists the project team(s) and/or other members of the Clinical Operations/Affairs Department in the development of plans and protocols for clinical research studies.
· Independently prepares/designs and/or reviews informed consent form templates, case report forms and instructions, site selection materials, procedural manuals, project newsletters, and other project-specific documents required for the conduct of clinical studies.
· Works with assigned team members to ensure Investigator Essential Regulatory Documents and contractual agreements are reviewed appropriately for completeness and compliance with applicable regulations and corporate policies; ensures appropriate follow-up for noted deficiencies.· Manages the study filing process, ensuring compliance with good documentation practices, good clinical practices, TriPath Imaging SOPs, and industry standards.· Performs filing duties and oversees the filing of study documents assigned to the Clinical Research Assistants.
· Participates in project team communications with internal staff, CRO personnel, other CRAs, and vendor representatives as required.· Prepares project team minutes when requested.
· Ensures adequate supplies, forms, equipment, study drug, etc. are provided to assigned sites as required. Coordinates the distribution of study materials to sites, CRAs, CRO personnel, etc., as required for the project.
· Drafts internal and external memos, reports, documents, and correspondence to assist in the ongoing management and coordination of assigned clinical trials.
· Provides assistance to Clinical Research Associates in monitoring study sites, as requested by the Clinical Trial Manager and Director of Clinical Operations/Affairs. Prepares site visit reports, follow-up letters, and other monitoring documentation as required per SOP and industry standards, under the guidance of the Clinical Trial Manager.· Assists in the data management, biostatistics, and report writing of trial data by ensuring the resolution of data queries, reviewing draft documents, tables and listings, and summarizing clinical trial data, as requested by the Director of Clinical Operations.· Under the general guidance of the Director of Clinical Operations/Affairs and Clinical Trial Manger(s), interacts directly with data management, biostatistics, and medical writing personnel.
· Provides clinical trial specialist training and mentorship to Clinical Research Assistants and new Clinical Trial Specialists.· Prepares training materials and delivers training sessions as required to support staff development activities.TriPath Imaging, Inc. is an equal opportunity employer that shares the vision of a diverse workplace.
If you would like to work with a team of passionate individuals, committed to making a difference in the lives of millions of people and you feel you possess the necessary requirements, please submit an updated resume and salary history via the link below.
Salary History must accompany resume to be considered
For more information please visit our web site at: www.tripathimaging.com
REQUIREMENTS
The ideal candidate will possess:
Bachelor’s degree (B.A.) from a four-year college or university; an Associates degree with an additional 2 years related experience, or a high school diploma with an additional 4 years of related clinical trial experience.3 – 5 years experience in the general operation of sponsored clinical trials.Familiarity with FDA regulations and guidelines.Exceptional attention to details skills.Strong written, oral communication, and computer skills.Ability to appropriately represent TriPath Imaging’s Clinical Operations Department to internal clients and external partners.Ability to work on problems of moderate scope where minimal direction is given for situational analysis. Ability to exercise judgment within broadly defined practices and policies to determine appropriate action. Normally receives minimal instructions on routine work and more detailed instructions on new assignments.Strong team player skills.Coordination of in vitro diagnostic (IVD) trials.