Clinical Research Associate II – FSP

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $91.5k - $137.3k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 0%

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Oversee all aspects of study site management to protect patient safety and ensure high-quality data and acceptable Quality Assurance reports • Provide guidance at site and project level toward audit readiness and support audit preparation and follow-up actions • Update, track and maintain study-specific trial management tools, systems and status reports • Manage site start-up procedures when required, including investigator feasibility and recruitment, EC/IRB submissions, regulatory document collection and review, informed consent adaptation, notifications, translations and meeting organization • Assist with study budget negotiation and investigator contract execution when required • Verify informed consent processes and documentation; assess subject safety and clinical data integrity risks • Independently conduct pre-study/qualification, initiation, routine monitoring and close-out visits in accordance with protocols, local laws, ICH-GCP and Precision SOPs • Prepare timely monitoring reports for on-site and remote visits • Document activities through confirmation letters, follow-up letters, trip reports, communication logs and other required project documents • Support subject/patient recruitment, retention and awareness strategies • Enter observations, status updates and action items into tracking systems and drive them to resolution • Review Investigator Site Files for accuracy, timeliness and completeness and reconcile them with Trial Master Files • Ensure investigator sites understand essential-document archiving requirements • Communicate protocol and study issues with site personnel and Precision Project and Clinical Trial Management • Maintain relationships with investigators and study staff and represent Precision’s quality and professional image • Perform investigational product inventory, reconciliation, storage and security reviews • Verify investigational product dispensing and administration and manage related blinded/randomized information and regulatory procedures • Perform remote EDC CRF and patient-profile data reviews, resolve queries and assist with data discrepancy resolution • Identify and process Serious Adverse Events according to study procedures • Identify site risks, escalate them with proposed contingencies and own timely resolution • Attend Investigator Meetings, sponsor meetings, global monitoring/project meetings and required clinical training • Travel as necessary according to project needs • Perform other duties assigned by management

🎯 Requirements

• 4-year college degree or equivalent experience in a scientific or healthcare discipline • Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies • Site management or equivalent experience in clinical research • Excellent communication and organizational skills • Team player • Client-focused approach • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail • Ability to travel overnight • Up to 60% travel on average, based on regional requirements; international travel as needed • Fluency in English and, for non-English speaking countries, the local language of the country where the position is based • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Paid parental leave • Paid time off for sick leave and vacation • Volunteer time off • Robust medical offerings • Non-vested 401(k) plus company match • Professional growth support • Reasonable travel and work/life balance