Senior Clinical Research Associate

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.

RESPONSIBILITIES

The Senior CRA has the primary responsibility of ensuring the rights and well-being of human subjects are protected, the reported trial data are accurate, complete and verifiable from the source documents. The Senior CRA oversees the overall conduct of the trial at their assigned study site(s) and ensures compliance with Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practices (GCP), other applicable federal and local regulations and guidelines, the company goals and agreed upon budgets.

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

Department Responsibilities

• 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
• Train entry-level and/or junior CRAs
• Support the onboarding and management of contract CRAs
• Lead relevant team trainings and knowledge sharing initiatives
• Participate in project and resource assignment decisions, as well as department recruiting and hiring process
• Contribute to thought leadership and knowledge sharing activities
• Participate in audits as necessary
• Perform other duties as required

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
• Oncology experience highly preferred

SKILLS

• Ability to travel as needed (anticipated at 40% - 60% 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 with limited supervision
• 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.)

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, strength, agility, dexterity flexibility, steadiness or reaction time.

The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.