Clinical Research Associate – Texas (San Antonio or Austin preferred) or Remote
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases.
Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers.
The Clinical Research Associate (CRA) provides support to multiple clinical study teams in the execution of clinical trials. Primary responsibilities include organizing and overseeing clinical studies or trials to contribute to advances in the medical community. Their duties include developing and outline trial protocols, establishing trial sites, training site staff and managing Investigational Product (IP) and trial materials.
The CRA manages quality controls and the execution of clinical protocol and data management for a number of clinical trials at multiple sites, ensuring compliance with all regulatory and contractual requirements. Establishes and maintains sound clinical and data collection practices to ensure validity of studies. Monitors the conduct and progress of the studies to ensure compliance with established protocols, appropriate research methodology, and study timelines. Participates in protocol development, site/investigator selection, study initiation and termination activities. Develops and completes final study reports.
The position reports to the Director of Clinical Affairs The head office is in the San Antonio, Texas area but flexible working arrangement will be in place post COVID-19.
CANDIDATES: please send cover letter and resume to firstname.lastname@example.org
Essential Duties and Responsibilities
Oversees the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies.
Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.
Assists in the identification of contract research organizations and centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities and participates in final selection.
Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.
Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.
Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.
Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems and clarifies and/or obtains changes to data as appropriate.
Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
BA/BS or equivalent degree in a scientific discipline, RN, or related field is required.
7-10 years’ experience in the pharmaceutical, biotechnology, CRO and/or healthcare setting.
Demonstrate basic understanding of medical terminology and clinical activities in relation to execution of Clinical Development Plan.
Strong knowledge and application of regulatory principles within an ICH/cGCP environment.
Professional licenses/ certifications preferred but not required.
~50% Travel required to various trial sites and agency locations.
Manage contract staff and vendors as needed to support regulatory activities.
Hire, onboard and manage clinical affairs professionals.
Ability to hear and speak to employees and business associates on the phone and in person.
Occasionally required to lift up to 20 lbs.
Regularly required to sit, stand, bend, reach and move about the facility.
Work performed in an office setting, ability to sit for long hours at a time.
Microsoft Office skills.
Working knowledge of the DIA TMF Reference Model, TMF maintenance and management of essential documents via an eTMF.
Experience in Sharepoint or similar filing systems is desirable.
Knowledge of electronic data capture systems and web-based clinical trial management tools.
Knowledge of statistical data collection, validation, editing and analysis techniques.
Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates.
Ability to exercise judgment within generally defined practices and policies that lead to methods or processes for obtaining results under supervision.
Ability to work independently and proactively, with minimal instruction and supervision, while working in a fast-paced environment with multiple deadlines and frequently changing priorities.
Superior oral, written, and interpersonal skills including ability to communicate effectively with people individually and in large groups.
Excellent time management skills with a proven ability to consistently deliver quality work and meet deadlines.
Superior problem solving, deductive reasoning and decision-making skills.
Ability to perform duties with integrity, professionalism, and confidentiality.
Ability to maintain and build strong working relationships and actively seek opportunities to influence, build trust and gain alignment with peers, functional leaders and/or external partners to accomplish tasks and business objectives.