ProTrials Research

In this position, the QA Specialist will support the ProTrials Quality Assurance department. The QA Specialist will maintain the ProTrials’ Controlled Document System and ProTrials Training Program, and other QA supportive Good Clinical Practice (GCP) activities per ProTrials procedures and applicable regulatory requirements (FDA, ICH, etc.). The QA Specialist will participate during Sponsor audits and/or regulatory inspections, as required. Responsible for assessing, evaluating, and reviewing corporate operations against GCP regulations to assure real-time observation of activities, issue identification/resolution, including proper and timely documentation Facilitates and conducts internal and external audits and provides metrics and analysis of trends based on audit findings Assist in the conduct or arrangement of GCP training for all staff Maintain the Controlled Document and Training systems and oversee administrative support utilized in maintaining systems Manage process and tracks controlled documents from the Document Change Control Form (DCRF) process until document approval or retirement, including updating related Controlled Document, training logs, and trackers Responsible for providing quality oversight to the revision, review, and approval of controlled documents Work with document reviewers to advise and revise controlled documents as appropriate and ensure reviews are performed in a timely manner Responsible for providing input and support as appropriate to the creation of new controlled documents Works with QA Management and other departments to identify gaps in controlled documents and recommends solutions Communicate effectively with staff and management across departments on status of Controlled Documents and corporate training Participate in inspection readiness activities and corporate audits, sponsor audits and/or regulatory inspections, as required Works closely with others to determine root cause and potential preventive/corrective actions in support of the corporate CAPA Program. Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations. Ensure support for the timely closure of investigations Assist QA management with the evaluation of learning management systems and other QA technology, as required Assist in the preparation of quality metrics and reports Assist QA management team with other Clinical QA activities as required Other duties, as assigned

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Clinical Project Manager (Clinical PM) plays a key role in the successful conduct of a clinical trial from inception through implementation and completion. The Clinical PM provides overall coordination and strategic management of a clinical trial, in conjunction with the clinical team and other functional groups. The Clinical Project Manager serves as the primary contact with the sponsor, clinical team, and other functional groups, while effectively delegating and overseeing team members. The Clinical Project Manager ensures that all study team members are appropriately trained on the study and maintain compliance with GCP, the protocol, other associated documents, scope of work, and other clinical objectives. The Clinical PM serves as an effective team leader who manages and motivates team members using positive and productive methods of communication. The Clinical Project Manager also supports team member mentorship, as needed. What You Will Do - Lead all clinical study operations, providing strategic/tactical planning, organization, and direction of study project(s) including oversight of clinical project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies, and data collection. - Facilitate and foster positive, productive, and timely communication between sponsor, study team, and other functional groups. - Manage and motivate study team while serving as a mentor; mentorship may include identifying skills of the clinical team members and assisting with further professional development. - Provide proper financial oversight of study budget, including out of scope tracking, in conjunction with the Client Manager (CM) and ProTrials Finance Department. - Collaborate with senior management to provide study updates/progress, resourcing needs, sponsor issues, and health status at regularly scheduled intervals. - Drive the development, maintenance, and distribution of project plans based on project-specific requirements, throughout the life of the study (i.e., monitoring plan, communication plan, project management plan, eTMF plan, other plans as applicable). - Manage studies in compliance with GCP, relevant SOPs, regulatory requirements, and project-specific plans. - Assess resourcing needs to ensure the study has the appropriate resources for the duration of the project. - Actively manage and track study risks (with team and sponsor input for potential obstacles that would delay the project’s progress while appropriately escalating issues). - Assess training needs of team members on the therapeutic area, protocol, special procedures/skills, and implement the appropriate training plans. - Delegate study team responsibilities and ensure that team members have the necessary tools and resources to effectively perform their role. - Monitor and manage the project’s progress and develop timelines with input from relevant stakeholders and sponsor approval; re-assess critical path for study progress and adjust timelines as needed. - Oversee activities and deliverables of outside vendors, as requested; ensure communication occurs between outside vendors, the team, and sponsor. Qualifications - RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CRA experience. - Outstanding interpersonal, oral, and written communication skills. - Proven effectiveness as a team leader. - Prior experience successfully managing multifaceted studies from inception through implementation and completion. - Outstanding organizational and time management skills. - Experience managing projects in a virtual environment. - Demonstrated ability to lead by example and to encourage team members to seek solutions independently. - Proficiency in Microsoft Word, Excel, and PowerPoint are required. - Experience with MS Project and OneNote a plus. Benefits - Your wellness matters to us – that’s why we provide full medical, dental, and vision insurance options for you and your family. - We know life doesn’t pause for work – we provide flexible PTO so you can take care of what matters, both personally and professionally. - You invest in your future – and so do we. Our 401(k) plan includes a company match to help you reach your financial goals. - At ProTrials, we are committed to your growth. Whether you’re looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward. - We have the best coworkers, if we do say so ourselves. - $128,000 - $182,000 a year.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a Sr. CRA include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. Sr. CRAs may be required to travel up to 65%. - Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits. - Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion. - Manage and track the preparation and return of investigational supplies at individual sites. - Monitor and document investigational product dispensing, inventory, and reconciliation. - Monitor and document laboratory sample storage and shipment. - Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities. - Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues. - Review data queries and listings, and work with study centers to resolve data discrepancies. - Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues. - Maintain complete and accurate study files and review files to ensure all appropriate documentation is present. - Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials. - Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues. Qualifications - RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career growth in the CRA position. - Detail-oriented. - Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills. - Flexibility with changing priorities. - Ability to efficiently perform and prioritize multiple tasks. - Familiarity with the medical and pharmaceutical industries, and related terminology and practices. - Extensive knowledge of FDA regulations and their practical implementation. - Ability to travel, including by air or by car on short notice. - Proficiency in Microsoft Word, Excel, and PowerPoint. Benefits - Your wellness matters to us – that’s why we provide full medical, dental, and vision insurance options for you and your family. - We know life doesn’t pause for work – we provide flexible PTO so you can take care of what matters, both personally and professionally. - You invest in your future – and so do we. Our 401(k) plan includes a company match to help you reach your financial goals. - At ProTrials, we are committed to your growth. Whether you’re looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward. - We have the best coworkers, if we do say so ourselves. - $130,000 - $155,000 a year.