Research associate serp_jobs.h1.location_city

The Clinical Research Coordinator, RN will work under the guidance of senior research staff to support the daily activities of early phase oncology clinical trials. The CRC, RN ensures the accurate and timely conduct of clinical research, adhering to protocols, regulatory requirements, and patient safety standards. This role involves direct patient interaction, data collection, and maintaining compliance with Good Clinical Practice (GCP). The Clinical Research Coordinator will be assigned multiple protocols at any time for which they will oversee the aspects of assigned protocols with planning and coordinating patient participation in the trial. Also, this role is responsible for implementation as well as completion of protocol specific requirements, providing accurate, up to date information to all team members involved with any aspect of carrying out protocol specific requirements.

Essential Responsibilities :

• Communicate on a regular basis with Study Sponsor's, CRO's, staff, etc. regarding questions, concerns, as well as status of the protocol.
• Monitor the overall day-to-day conduct of assigned studies in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study.
• Create / review forms created or revised for assigned trials to assure protocol compliance.
• Maintain files using standardized study document labeling and filing procedures.
• Implement initial protocol and amendments, training staff who will be involved in patient treatment and management.
• Maintain an up-to-date contact list.
• Assist with patient screening and determination of eligibility.
• Facilitate the informed consent process ensuring that consent is appropriately completed.
• Prepare and manage source documents according to standard operating procedures.
• Recognize deviations to the protocol and will work with leadership and staff to address corrective actions to prevent deviations.
• Assist data coordinator team with case report form completion and query resolution.
• Work with the Principal Investigator to complete and submit Serious Adverse Event reports.
• Perform protocol specific closeout related activities in conjunction with the data coordinator.
• Provide documentation for all deviations whether related to the protocol or a SOP.
• Ensure that all team members involved understand and adhere to assigned protocols.
• Perform telephone triage assessments of patients on trial when necessary.
• Provide patient education regarding participation in a clinical trial, chemotherapy / biotherapy / investigational agent administration and potential side effects.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity / affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and / or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy : https : / / insightglobal.com / workforce-privacy-policy / .

Required Skills & Experience

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and / or other paid time off as provided by applicable law.