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FSP - In House Clinical Research Associate

Parexel International Corporation

USA - Any Region - Home Based

About ExecuPharm

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Position Purpose:

This “ in-house ” CRA position is responsible for supporting study and site management activities and may include coordination, administration, or management of specific trial activities. An In House CRA may also be responsible for a management of some Client clinical trial sites. This role focuses on performing all activities required to evaluate, initiate, monitor and close clinical trial sites.

Primary Duties: Assist, or may lead Clinical Trial Management effort to develop, review and track study documents, including, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals. Ensure the the Clinical Trial Master System (CTMS) and Trial Master File (TMF) are maintained in an inspection-ready state. Review for compliance and address findings as needed. Track site and study status as assigned. Assess adequacy of potential clinical investigators and clinical trial sites. Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH. Train clinical investigators and their personnel in regard to clinical trial protocol and regulatory requirement. Collect and review site essential documents, including site Informed Consent Form (ICF) changes Act as a primary contact with field CRAs, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites. Monitor compliance with the clinical trial protocol, CFR, GCP/ICH guidelines, and overall protocol objectives. Assist with management and accountability of clinical trial supplies, including Investigational Product, research specimen samples and/or radiology scans Assist with management of clinical trial safety and efficacy issues, including, but not limited to: review and follow-up of Serious Adverse Event reports. Perform data listings review and generate of data queries Assist in the preparation and follow-up of in-house and on-site Client sponsored quality audits, as well as, regulatory authority inspections. Conduct clinical team meetings, including agenda preparation, minutes, and action item tracking as assigned Ensure appropriate CRF completion and review and approval of clinical trial site monitoring reports Assist with the review and analysis of clinical data for clinical trial report generation. Assist with review, approval and reconcilition of clinical trial related invoices Actively contribute to process improvemen May conduct clinical trial site co-monitoring and independent monitoring visits including: Pre-study, Initiation, Interim Monitoring, and Close-out visits. Follow all outstanding site issues to resolution and/or document attempts to resolve issues upon closure of clinical trial sites QualificationsMore about you

On your first day we’ll expect you to have:Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.The ability to function as a mentor and role model for other CRAs.Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.Strong interpersonal, written, and verbal communication skills within a matrixed team.Experience working in a self-driven capacity, with a sense of urgency and limited oversight.A client-focused approach to work and flexible attitude with respect to assignments/new learning.The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).An honest and ethical work approach to promote the development of life changing treatments for patients.Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.A little about us

Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you’ll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or collaborator are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level CRA role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees.EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2021-09-25

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