Clinical Research Associate II - FSP

Precision for Medicine

17h • $91,500 - $137,300

About The Position

Precision for Medicine is hiring a Clinical Research Associate II to support clinical research programs. The CRA II is an experienced monitoring and site-management professional who works independently as a study team member. Responsibilities vary according to the assigned program and may include study start-up and implementation, on-site and remote monitoring, and ongoing site management. The role supports studies in areas including Oncology, Cardiology, or Lupus and requires travel according to project needs, averaging up to 60% based on regional requirements, with international travel as needed.

The CRA II oversees site management to protect patient safety and ensure high-quality data, audit readiness, and compliance with protocols, local laws, ICH-GCP, and Precision SOPs. The role conducts site visits, maintains study records and tracking systems, reviews data and investigational product handling, supports recruitment and retention, and communicates study risks and issues to site personnel and project management. The position also contributes to site start-up, regulatory submissions, contracts, investigator meetings, and audit preparation when required.

Precision for Medicine is a precision medicine CRO combining clinical trial design and operations with medical expertise, biomarker and data analytics, and specialized support for complex disease states. The company describes its work as helping advance precision medicine and targeted clinical trials.

Requirements

• Four-year college degree or equivalent experience in a scientific or healthcare discipline.
• At least two years of experience as a CRA in a CRO, or equivalent relevant experience and/or demonstrated competencies.
• Site-management or equivalent clinical research experience.
• Excellent communication and organizational skills, and the ability to work as a team player.
• Evidence of a client-focused approach.
• Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
• Ability to travel overnight; travel averages up to 60% based on regional requirements, with international travel as needed.
• Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based.
• Ability to work independently and as part of a team, plan work, and demonstrate self-motivation.
• Working knowledge of clinical trial methodology, protocols, and indications being studied.
• Professionalism, punctuality, reliability, service orientation, and positive interactions with customers and teammates.
• Ability to collect data to a consistently high standard.
• Ability to deliver formal presentations proficiently to colleagues, investigative staff, and clients.

Nice To Haves

• Graduate or postgraduate degree.
• Lupus monitoring experience.
• Experience monitoring studies in rare and complex therapeutic areas.
• Experience monitoring EDC trials and EHR records.
• Experience in biopharma or a relevant therapeutic area.
• Relevant site start-up experience in the applicable country, including feasibility, contract negotiations, and submissions.
• Ability to monitor study sites with supervision according to protocol monitoring guidelines, SOPs, GCP, and ICH guidelines.
• Ability to resolve project-related problems and prioritize workload to meet deadlines with minimal management support.

Responsibilities

• Oversee study-site management to protect patient safety and support high-quality data, low query levels, and acceptable Quality Assurance reports.
• Provide guidance on audit-readiness standards and support audit preparation and follow-up actions.
• Maintain study-specific trial management tools, systems, and status reports.
• When required, manage site start-up, including investigator feasibility and recruitment, EC/IRB submissions, regulatory document collection and review, informed-consent document review and adaptation, notifications, translations, meeting organization, and related tasks.
• When required, assist with study-budget negotiations and investigator contract execution under the direction of Site Contract Management or a designee.
• Verify that informed consent is properly obtained and documented, and assess site factors that may affect patient safety or data integrity, including protocol deviations and pharmacovigilance issues.
• Independently conduct pre-study or qualification, initiation, routine monitoring, and close-out visits in accordance with the protocol, local laws, ICH-GCP, and Precision SOPs.
• Prepare and submit accurate, timely monitoring reports for on-site and remote visits.
• Document activities through required confirmation and follow-up letters, trip reports, communication logs, and other project documentation.
• Support subject recruitment, retention, and awareness strategies; record observations, status, and action items in tracking systems and follow them through resolution.
• Review Investigator Site Files for accuracy, timeliness, and completeness; reconcile them with the Trial Master File and ensure sites understand essential-document archiving requirements.
• Communicate proactively with site personnel and Precision project and clinical trial management about study issues and deviations, and implement necessary actions.
• Build and maintain effective relationships with investigators and study staff, representing Precision's professional and quality standards.
• Inventory and reconcile investigational product; review storage and security; verify dispensing and administration; assess risks relating to blinded or randomized information; and ensure appropriate relabeling, import, release, or return.
• Review remote EDC case report forms and patient profiles, resolve queries, and assist data management and clinical data quality staff with discrepancies.
• Identify and process Serious Adverse Events according to study procedures and demonstrate understanding of SAE reporting.
• Identify site risks, escalate them with suggested contingencies, and lead timely resolution with minimal project-team support.
• Prepare for and attend investigator and sponsor meetings, global project and monitoring meetings, and required clinical training.
• Travel as necessary according to project needs and perform other duties assigned by management.

Benefits

• Paid time off.
• Volunteer time off.
• Medical offerings and health insurance.
• 401(k) retirement savings plan with company match; described as non-vested 401(k).
• Paid parental leave.
• Life insurance.
• Disability benefits.
• Paid sick leave and vacation.
• Eligibility for a discretionary annual bonus.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level