CRA (Direct Hire/Northeast-Midatlantic)

KPS Life is looking for CRAs for a direct hire opportunity with our Endocrine focused biotech client.

• Do you have 2+ years of pharmaceutical industry experience as a CRA/Site Monitor and are located from DC/Virginia up through New England or Ohio area?
• If so, reach out to one of our recruiters today to discuss this great opportunity to work directly with a growing biotech company!

Position Summary

The Clinical Research Associate (CRA) will participate in the preparation and execution of Phase l-3 clinical trials. The CRA oversees the progress of clinical investigations by conducting site qualification, initiation, interim, and close-out visits. The CRA monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by Company and partner CRO(s). The CRA works closely with the Clinical Trial Manager (CTM) and Clinical Monitoring management to ensure all monitoring activities are conducted according to study requirements.

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Develops strong, collaborative investigational site relationships and ensures continuity of relationships through all stages of the trial.
• Performs clinical study site management/monitoring activities efficiently in compliance with GCP/ICH requirements, SOPs, local laws and regulations, protocol, Clinical Monitoring Plan, and associated documents.
• Demonstrates an in-depth understanding of the study protocol and related procedures.
• Participates and provides input on site selection and site qualification activities.
• Coordinates and manages assigned tasks in collaboration with the study team to achieve site activation.
• Performs remote and on-site monitoring activities using various tools to ensure subject rights, safety and well-being are protected as well as the reliability and integrity of study data.
• Conducts site visits including but not limited to qualification visits, initiation visits, interim monitoring visits, and close-out visits; generates clear, comprehensive, and accurate visit reports and letters in a timely manner.
• Reviews and verifies study records including source documents, case report forms, informed consent forms and other materials to ensure data is complete and accurate.
• Interacts with the clinical study sites to resolve data queries and/or data entry errors and obtain additional information on potential serious adverse events.
• Assess and monitor investigational product receipt, storage, administration, accountability and return processes.
• Collects, reviews, and monitors essential regulatory documentation maintained by the site for study start-up, study maintenance, and study close­ out.
• Submit site essential documents to the TMF following inline quality review and resolve any quality issues related to submitted documents.
• Trains and assists site coordinators, investigators, and CRO (as applicable) in collecting data and executing the study in a timely manner that meets the protocol requirements and timelines/milestones; serves as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols.
• Communicates and documents contacts with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, adverse event reporting, site audits/inspections, and overall site performance.
• Identifies, assesses, and resolves site performance, quality or compliance problems and escalates as needed per defined escalation pathway in collaboration with CTM and/or Clinical Monitoring management.
• Assists in the development and implementation of subject enrollment and recruitment strategies for site.
• Manages and maintains visit information such as site/subject visit tracking and other documentation in Clinical Trial Management System (CTMS), Trial Master File (eTMF) and other systems.
• Completes routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense submissions and approvals as needed).
• Ensures internal and study-related trainings are completed per study timelines.
• Ensures all study deliverables are completed and study timelines.
• May conduct co-monitoring, data collection visits with Company or CRO CRAs.
• Performs other Clinical Operations duties, as requested.

Required Education and Experience:

• Bachelors in biological sciences or related discipline with at least 2 years of experience in the role of Clinical Research Associate (an equivalent combination of experience and education may be considered).
• Demonstrates critical thinking, root cause analysis and problem solving to identify site process failures; develop corrective and preventative actions to bring sites into compliance.
• Ability to motivate clinical site personnel to compliantly maintain/accelerate timelines to achieve clinical operational milestones.
• An understanding and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements. Able to comply with safety standards and respect privacy and confidentiality.
• Advanced writing skills as they relate to the preparation of clinical trial documents.
• Advanced interpersonal skills with strong oral/written communication and presentation skills.
• Advanced negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
• Well versed with the latest trends in the clinical trial industry.
• Monitoring experience in startup, execution and close out activities related to clinical studies; experience using risk-based monitoring processes preferred.

Vaccination Requirement

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, The Company requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

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