Sr. CRA (Direct Hire) Northeast/Mid-Atlantic Region

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

• Do you have 5 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 Senior Clinical Research Associate (Sr. CRA) will participate in the preparation and execution of Phase 1-3 clinical trials. The Sr. CRA oversees the progress of clinical investigations by conducting site qualification, initiation, interim, and close-out visits. The Sr. CRA monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by Company and partner CRO(s). The Sr. CRA works closely with the Clinical Trial Manager (CTM) and Clinical Monitoring management to ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also participate in monitoring oversight activities such as CRO oversight visits, internal CRA training and evaluation visits, and CRO monitoring visit report review.

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Develop strong, collaborative investigational site relationships and ensure continuity of relationships through all stages of the trial.
• Perform 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.
• Participate and provide input on site selection and site qualification activities.
• Coordinate and manage assigned tasks in collaboration with the study team to achieve site activation.
• Perform 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.
• Conduct site visits including but not limited to qualification visits, initiation visits, interim monitoring visits, and close-out visits; generate clear, comprehensive, and accurate visit reports and letters in a timely manner.
• Review and verify study records including source documents, case report forms, informed consent forms and other materials to ensure data is complete and accurate.
• Interact 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.
• Collect, review, and monitor 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.
• Train and assist 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; serve as a resource to site

coordinators, investigators and other staff members regarding investigational products and protocols.

• Communicate and document 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.
• Identify, assess, and resolve site performance, quality or compliance problems and escalate as needed per defined escalation pathway in collaboration with CTM and/or Clinical Monitoring management.
• Assist in the development and implementation of subject enrollment and recruitment strategies for site.
• Manage and maintain visit information such as site/subject visit tracking and other documentation in Clinical Trial Management System (CTMS), Trial Master File (eTMF) and other systems.
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense submissions and approvals as needed).
• Ensure internal and study-related trainings are completed per study timelines.
• Ensure all study deliverables are completed per Crinetics and study timelines.
• Perform other Clinical Operations duties, as requested.

These activities may be performed by the Senior Clinical Research Associate depending on study assignment:

• Review protocols, eCRFs, study manuals and other related documents, as requested by the CTM and Clinical Monitoring management.
• Conduct CRA monitoring assessment visits, as needed.
• Conduct co-monitoring, data collection visits with Company or CRO CRAs, as needed.
• Provide training/mentoring on operational tasks/projects to more junior staff.
• Conduct monitoring oversight visits (MOVs) with CRO CRAs to assess compliance to the protocol and Clinical Monitoring Plan and document results of the visit.
• Review monitoring visit reports from CRO and escalate monitoring trends or findings to the CTM and Clinical Monitoring management.

Required Education and Experience:

• BS in biological sciences or related discipline with at least 5 years of experience in the role of Clinical Research Associate
• Demonstrate an in-depth understanding of the study protocol and related procedures.
• Demonstrate 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.
• Excellent writing skills as they relate to the preparation of clinical trial documents.
• Excellent interpersonal skills with strong oral/written communication and presentation skills.
• Excellent 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.

#LI-Remote

#kpslife