Mission

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Clinical Research Assistant II your primary responsibilities include providing support to the Clinical Research Nurse, Clinical Research Coordinator (CRC) and Data/Regulatory Coordinator daily. You will ensure all activities are conducted according to company standard operating procedures (SOPs) and all applicable Good Clinical Practice (GCP) and ICH regulations and guidelines. You will assist CRC and Research RN in screening, enrolling and following study subjects ensuring protocol compliance and close monitoring while the subjects are on study. You will be responsible for assisting in data collection, regulatory requirements, source documentation, completing study specific case report forms, and submission of adverse experience reports. You will schedule consultations, diagnostic tests or procedures, and future appointments for patients with physicians as requested.

You may assist with collecting and processing specimens for research purposes. May maintain supplies, drugs and storage facilities for clinical research as appropriate

You will review the study design and inclusion/exclusion criteria with physician and patient

You will ensure the protection of study patients by verifying informed consent procedures and adheres to protocol requirements/compliance

You will enter data into study specific case report forms or electronic data capture systems for each assigned clinical trial.

You will resolve queries in electronic data capture systems for each assigned clinical trial.

You will maintain accurate and complete records including, signed informed consent forms, source documentation, drug dispensing logs, subject logs, study-related communications and regulatory documents when applicable.

You will obtain source documentation for patients enrolled into clinical trials.

You will investigate and report protocol deviations, when applicable

You will assist in SAE reporting and tracking.

You will create and maintain patient visit tracking spreadsheets for assigned clinical trials

You will create imaging requests, manages imaging tracker, answers queries, and uploads images per imaging guidelines for assigned clinical trials.

You will report required metrics to leadership team.

You will work with the Research Team to meet industry trial data deadlines.

You will establish and maintain positive relationship with Clinical Research Associates (CRA)

You will assist in maintaining study administrative files.

You will assist in managing monitor visits including resolution of follow up items.

You will escort monitors to and from the secured Monitoring Suite area

You will meet with monitors, study sponsor representatives and auditors as requested for assigned clinical trials

You will assist in tracking documents pending site regulatory signatures for assigned clinical trials

You will assist in routing and tracking completion of protocol training for assigned clinical trials

You will maintain updated physician credentials and other critical documentation ensuring compliance

You will maintain FDA and GCP required regulatory documentation for individual site, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content

You will triage site requests for regulatory support and identifies correct pathway for issue resolution

You will provide site level regulatory support to the site in relation to the status of start-up and ongoing regulatory maintenance

You will assist other colleagues as requested and performs other related work as needed.

You will assist in maintaining document management for regulatory paper and electronic files for each study at the site

You should have for this position: Knowledge of scientific, medical, and regulatory terms preferred

Knowledge of GCP and GMP

Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, Microsoft Office (Outlook, Word, Excel, and PowerPoint) and SharePoint.

One year of clinical experience preferred

One year of research and/or oncology experience preferred

SOCRA or ACRP certification preferred

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As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.