Temporary Clinical Research Associate (Remote)

Job Description

The Temporary CRAwill have a thorough knowledge of clinical trial processes, familiarity with the electronic systems utilized for the conduct of the trial, the ability to interact with the cross-function study team/vendors, as needed. This role is accountable for site management and monitoring responsibilities with a focus on quality execution and ensuring clinical trial participant safety, and protocol and ICH-GCP compliance.

The Temporary CRA role will be responsible for providing advanced supported to the clinical team in the overall management of the planning, execution, and closeout of one or more clinical trials. The Temporary Senior Clinical Research Associate will have a thorough knowledge of clinical trial processes, advanced familiarity with the electronic systems utilized for the conduct of the trial and the ability to interact with the cross-function study team/vendors. This role is accountable for ensuring individually assigned and team responsibilities are performed with a focus on quality execution and ensuring clinical trial participant safety, and protocol and ICH-GCP compliance.

· Accountable for providing oversight of the entire site management process for the life cycle of the assigned sites, with the development of essential documents and tracking of site performance metrics.

· Accountable as an initial escalation point for building and maintaining positive

· Accountable for reviewing and approving all trip reports for assigned sites, identifying and ensuring potential issues related to site and/or monitor performance are addressed or escalated, as appropriate.

· Accountable for ensuring the PM and/or line management is kept informed of identified issues related to clinical trial conduct or individual performance.

· Determine and drive the site selection and initiation process (track and report progress, review data) ensuring that all sites are selected, and supplies provided in accordance with study start expectations.

· Works with PM and line management to ensure appropriate CRA resources are allocated and available to support the monitoring plan including CRA site assignments

· Develop and may finalize the country recruitment/retention strategy in collaboration with the Project Manager (PM). Identify potential risks to the enrolment targets based on feasibility analysis in collaboration with the PM.

· In collaboration with LCTA and other key contributors, develop the Informed Consent (ICF) template in accordance with Corbus SOP.

· Develop SSV/SIV/IMV and other training tools and training materials in support of the project for the project assigned CRAs.

· Develop study tools for sites and CRA use.

· Ensure that monitoring visits are performed in accordance with protocol/SOP requirements and that these are tracked, including report status and sign off.

· Accountable for the quality of the trip report content and sign off timelines for all assigned sites.

· Facilitate the review of the Monitoring Guideline and ensure that a member of the CRA project team and other appropriate team members provide input.

· Generate potential site list from key stakeholders and drive site feasibility process in collaboration with the Lead CTA.

· May provide review of eCRF.

· Provide review of protocol and protocol amendments for operational complexity, completeness, and quality.

· Responsible for the development of any mass site communication, as appropriate.

· Responsible for developing and maintaining the project Q and A documents.

· Responsible for ensuring internal productivity metrics, especially for trip report completion within the assigned timeframes and to the expectations of Project Management and SOP.

· Review and enter all protocol deviations in collaboration with the CRAs.

· Review and provide input to the Trial Manuals and ensure distribution to assigned sites and project team members as appropriate (CRAs).

· Accountable for the quality of site performance for assigned sites. Responsible for collaborating with the CRA to develop any Corrective Action Plan (CAPA). Accountable for ensuring that the CAPA is delivered and issues escalated to the PM in accordance with the escalation pathway. Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits, including file review according to the CTM Audit Management Plan

· Provide support and identification of lessons learned and share across the project team members.

· May conduct various types of sign off and assessment visits to ensure Clinical Operations on-site performance.

· Collaborate cross-functionally with supply chain, data management, pharmacovigilance, and other departments within Corbus to facilitate timely execution of study milestones

· Work with Clinical Trial Associate to create seamless end to end site management

· Participate in internal and external meetings (investigator meetings, therapeutic area conferences, patient workshops) to represent Corbus and enhance understanding of therapeutic indications

· Participate in clinical site identification, feasibility, and selection process, and teaching potential sites about the protocol and study requirements for upcoming trials.

· Manage study start-up activities including assisting with site contract and budget negotiation, facilitating IRB submissions and approvals, and ensuring that sites have received proper study materials.

· Liaise with the third-party vendors (i.e., central lab, specialty labs, study equipment providers) to ensure efficient processes are in place and preparation for delivery of study materials to investigator sites.

· Promote patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters, or other) to sites.

Qualifications

· Must have a minimum of a bachelor’s degree in a health or science related field

· At least 3 years experience in relevant field (e.g. CRO, Sponsor) and at least 2 years functioning as a CRA

· Ability to travel up to 70-80% to locations nationwide is required

· Must maintain a valid driver’s license and the ability to drive to monitoring sites

· At least 2-year healthcare-related work experience

· Strong communication and presentation skills

· Must be detail-oriented and efficient in time management

· Working knowledge and experience with clinical systems (i.e. Electronic Data Capture (EDC) systems, TMF and CTMS)

· Knowledge of ICH-GCP guidelines, human subject protection (HSP) and patient privacy requirements, clinical trial monitoring, and/or regulatory compliance

Additional Information

All your information will be kept confidential according to EEO guidelines.