Clinical Research Associate Jobs

Minimum requirements:

A bio-medical related scientific degree or relevant experience with a strong interest in clinical research. Minimum of Bachelor degree preferred. 3-4 yrs CRA, site management and monitoring experience on behalf of a sponsor/ CRO/relevant site or lab experience as it pertains to the role is required as well as knowledge of U.S. (or relevant country) regulations governing clinical trials.

Role Competencies:

• Excellent organization skills with attention to details and time management, bringing forward ideas and paths for building on organizational tools
• Open and clear communicator, able to provide meaningful and motivating feedback to site personnel
• Able to work quickly and independently, providing updates to managers, in a remote environment and under pressure with a sense of urgency for completion of work
• Independent proactive problem solver, possess sound judgement and discretion, informing leadership and getting buy in as appropriate
• Able to give and receive feedback and owning and taking responsibility for actions, working to improve using lessons learned escalating and recommending process changes to management as appropriate, potentially sitting on working groups or delegating a staff member to sit on a working group to implement
• Manage drafting and finalization of protocol and associated documents, including identifying need for amendments
• Computer skill proficiency with an ability to use the following tools with some training (previous experience a plus): Microsoft Office Applications (Word, Excel, Powerpoint, Outlook, Sharepoint), Smartsheet, Zoom and Asana
• Consistently creates pathways for process improvement, streamline workflows and build efficiently for individual and project outcomes with little guidance from manager
• Able to work independently and within a team. Consistently leads a project or study, playing a significant role in contributing to its success
• Works within timelines with limited oversight from manager, informing managers of any potential issues with timelines, bringing solutions/mitigations as necessary
• Confident and influential approach, leading meetings, reviewing documents, reviewing jr. team members work as appropriate
• Self-motivated, able to prioritize and take initiative, check in on timelines with managers for alignment, sets and meets timelines and communicates deliverables and drives progress
• Excellent written and verbal communication and interpersonal skills
• Consistently able to lead, motivate and understand the needs of others
• Expert on applicable clinical trial regulatory requirements, current GCP/ ICH/ HSP guidelines applicable to the conduct of Pharmaceutical sponsored clinical research, may have other specialties (ex-US, special projects or initiatives)
• Able to qualify for a major credit card for car and hotel rental charges and hold a valid state issued Driver's license

Senior CRA Responsibilities

• Ensure clinical trial sites are audit ready via assisting to resolve monitoring and auditing findings.
• Collect, manage, file and archive study documentation and correspondence. Assist in the accuracy and completeness of the Trial Master Files (TMF)
• Create back up plans as needed for successfully assisting sites reach agreed upon goals, serving as an escalation for jr. staff having issues getting goals met.
• Ensure each site has the trial supplies needed to safely conduct the study. Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
• Effectively communicate, facilitate exchange of ideas, and collaborate with Investigators, site staff, cross functional teams and other internal and external stakeholders. Oversight and review of training materials for site teams.
• Responsible for all aspects of study monitoring process (including site selection visits, initiation visits, interim monitoring visits, close out visits) to ensure site’s compliance to the study protocol, subject safety and applicable regulatory requirements including on time reports, conf. and follow up letters. May review jr. staff members report, conf. and follow up letters.
• Lead team meetings
• Prepare and lead others in the preparation of study materials such as training slides and/ or other study documents
• Prepare, review, maintain, and mentor staff in accurate monitoring reports and sponsor/ Site correspondence within assigned timelines
• Other duties as assigned
• Ensure and mentor and in cases, where appropriate, manage jr staff in integrity of site collected data, accurate resolution of data queries, creation of clean data within timelines for database locks. Identifies site performance trends, with escalation and re-training as needed.
• Serve as main point of contact for Investigative Sites to facilitate the proper conduct of the study by ensuring compliance with GCP/ICH guidelines, regulations, SOPs, ALCOA principles and training/ study/ safety monitoring plans. Activities include but not limited to source data verification and review of all required essential documents necessary for study initiation to close of study to ensure subject safety, reporting of quality data, Investigator oversight, drug accountability, ISF/ regulatory compliance, AE reporting and audit ready study files through duration of study.