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Clinical Research Associate Manager

Company: Prometrika LLC
Location: Cambridge
Posted on: August 2, 2022

Job Description:

Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We---re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. The CRA Manager will be responsible for managing PROMETRIKA---s pool of CRAs and will also be assigned his/her own studies/sites to actively monitor. The expectations are that approximately 60% of the time will be spent on management responsibilities and 40% of the time will be spent on monitoring activities. Responsibilities of the CRA Manager include, but are not limited to the following: Management Responsibilities Recruit, develop and supervise CRA team members as appropriate to ensure qualified monitoring resources are assigned to meet the service obligations of the department Oversee CRA quality performance and compliance for all clinical monitoring activities Monitor CRA Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) to ensure high quality and timely deliverables, identify areas of risk and support needs, develop corrective and preventive action plans as necessary Contribute to Standard Operating Procedures, manuals, forms and templates to support efficient and compliant best practices of the department Collaborate on the development and improvement of CRA relevant department standard budget and proposal template items, client relations materials and process development initiatives Collaborate cross-functionally to create procedures serving the best interest of the entire company Participate in business development initiatives, such as proposals, requests for information, bid defenses, capabilities presentations, etc. Continually identify, recommend and implement innovative process ideas and technologies to elevate PROMETRIKA---s core competencies and offerings, with a focus on improving study monitoring activities and standard processes Support the implementation of new technologies to enhance clinical operations capabilities, including participating in user acceptance testing, developing of training manuals and serving as the subject matter expert (SME) as requested Train entry-level and/or junior CRAs Support the onboarding, management and retention of contract CRAs Manage and continuously improve the CRA onboarding and retention program Review and approve contract CRA invoices Review and approve CRA timesheets, as required Lead relevant team trainings and knowledge sharing initiatives Contribute to thought leadership and knowledge sharing activities Participate in audits as necessary Perform other duties as required Project-Related Responsibilities Provide oversight and tracking of study monitoring activities, inclusive of regional Clinical Research Associate (CRA) selection and management, trip report review, and performance of monitoring/co-monitoring visits/observation visits Contribute to the development of key study documents in conjunction with Clinical Trial Managers and other functional area leads (e.g., protocols, model informed consent forms, case report forms [CRFs], study manuals, clinical monitoring plans, laboratory manual, pharmacy manual, training materials and site initiation slide presentation) Participate in vendor selection, vendor qualification and vendor management for outsourced clinical operations activities, as required Participate in quality risk assessments and develop Key Risk Indicators (KRIs), as well as risk management activities during the study Site management activities, including but not limited to, site training/support, overseeing the timely resolution of data entry queries and missing data, overseeing the timely resolution of site monitoring findings, tracking of enrollment/patient status activities, confirming compliance site informed consent procedures, conduct IP accountability, clinical supplies management, identify and report protocol deviations Identify and support resolution of site performance issues related to the study protocol and ICH/GCP/regulatory compliance, subject recruitment and/or data entry requirements. Recommend corrective and preventive action plans (CAPAs) as required and track the timely resolution of agreed upon actions. Confirm effectiveness of the implemented risk strategies Perform study site monitoring visits (site qualification, study initiation, routine monitoring, study close-out) per the monitoring plan schedule. This includes the timely sending of confirmation and follow up letters, and the completion of a high quality, clear visit report for all visits Perform remote monitoring activities and detection of potential trends or issues Perform centralized monitoring activities and the aggregate review of site and study level data. Work with the eTMF Specialist and Sr. CTA/CTA to develop and maintain Clinical Study Files (i.e. eTMF). Interface with study sites to ensure that documentation is complete, accurate, and current. Assist with recurring eTMF reconciliations and the resolutions of identified issues, as necessary Assist Safety Management team in the reconciliation of SAE case management Maintain study specific tracking via CTMS or other tools Provide trial site updates and identify risks to project timelines to the Clinical Trial Manager and/or Lead CRA according to study specific monitoring guidelines, and in a timely fashion Assist with site investigator grant reconciliations as necessary Assist Medical Writing department as needed with quality control checks of clinical study reports and drafting of safety narratives Achieve department key performance indicator (KPI) goals for assigned project work. Proactively identify potential risks to achievement and propose improvement solutions as necessary Attend project meetings and teleconferences as per monitoring guidelines May attend and present at the Investigator Meetings Assist in the preparation for, and participates in site audits and inspections; assists in responding to any issues identified within the timeframe specified Maintain/develop scientific knowledge within the project---s therapeutic area Maintain effective, collaborative and meaningful communication between study site(s), clinical team, and the sponsor to ensure the successful execution of the clinical trial EDUCATION: Bachelor---s degree in a scientific discipline required Candidates with a clinical training/licensure (e.g., RN, LPN) with relevant experience will also be considered EXPERIENCE: Minimum of 10 years of CRA experience required, with at least 3 years of Lead CRA or CRA Manager experience Oncology experience highly preferred SKILLS: Demonstrated expertise in leading and supervising teams and in providing guidance and mentoring Demonstrated ability to accurately identify and resolve problems Demonstrated ability to effectively procure, manage, and control project resources Ability to travel as needed (anticipated at roughly 20%-25% of time) Excellent written and oral communication skills Excellent organizational skills and an astute attention to details Demonstrated ability to function effectively as a study monitor Prior experience observing and training junior CRAs, or performing GCP audits, a definite plus Familiarity with PCs and standard Microsoft Office software applications Familiarity with Medidata technical tools (e.g. Rave EDC, RCM eTMF, CTMS, Medical Imaging, TSDV, Patient Cloud, etc.) Solid understanding of the drug development process Advanced ability to work in a matrix environment and developing collaborative partnerships with internal and external stakeholders PHYSICAL REQUIREMENTS: Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, agility, dexterity flexibility, steadiness or reaction time.

Keywords: Prometrika LLC, Cambridge , Clinical Research Associate Manager, Executive , Cambridge, Massachusetts

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