CRC II (Onsite) - Memphis, TN

Job Responsibilities

• Review and prepare assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources.
• Maintain the Investigator Site File and/or Trial Master File (TMF) for the study.
• Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings).
• Lead and/or coordinate all required start-up activities, including clinic logistics planning, schedule of clinic activities, and team training.
• Prepare and review clinic source documents, time and events tables, and other required study materials; review Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules.
• Collaborate with responsible teams to establish and/or maintain safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study.
• Support the Principal Investigator as needed with study-related tasks such as delegation of authority, management of daily tasks, visit calendar development and maintenance, scheduling and attending monitor visits, and advertising, recruiting, and screening potential participants for the study.
• Conduct all study activities following Good Clinical Practices (GCP); protect the safety of human subjects; monitor appropriate sources for specific clinical study or federal regulation updates; collect and enter study data into the appropriate system; coordinate and monitor screening activities; provide support as required; submit data in required timeframe; complete Case Report Forms; facilitate audits of study data; develop patient rapport to explain research protocols and minimize protocol violations; develop rapport with study team to educate team on study procedures and minimize protocol violations.
• Take the lead and/or overall coordination of clinic activities, including supervision of clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and providing on-call support when applicable; screen eligibility prior to randomization; oversee, coordinate, and/or perform study drug administration, and other activities as delegated and required.
• Monitor that all study-related activities are conducted according to protocol, SOP, and applicable regulations; review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings.
• Coordinate resolution and/or address Quality Control (QC), monitor, CRF, or other internal/external findings; review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation; review and update Trial Master File (TMF) documentation; finalize study and/or volunteer logs; ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.).
• Monitor subjects' compliance throughout the trial and address day-to-day subject or study issues and escalate as appropriate.
• Prepare for and participate in sponsor/monitor/QA audits; provide accurate and timely project status updates to Project Managers and sponsors; collaborate within and between teams during process improvement exercises, SOP creation, and other company-related initiatives and goals.
• Accommodate flexible schedule (available days, afternoons, nights, and weekends).
• Perform other work-related duties as assigned.
• Coordinate and perform regulatory activities, including maintaining proper protocol, consent, amendment, and yearly renewal submissions if requested; report adverse events relating to the trial; maintain study files.

Qualification Requirements

• Registered Nurse and/or University Degree such as Bachelor of Science Degree required.
• Clinical Research certification preferred.
• A minimum of 1 year experience in clinical research required, preferably in coordination of clinical research projects. 2+ years preferred.
• Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines.
• Required skills: problem solving, planning, and evaluation; good time management, detail-oriented, and able to multi-task; good interpersonal and communication skills with a team focus; knowledge of SOP writing; ability to anticipate problems and provide solutions in a timely manner; ability to coordinate multiple clinical research projects with competing deadlines; proficiency in computer software programs (e.g. Word, Excel, Power Point); proficiency in use of various clinical trial EDC software preferred.

Benefits

• Company car or car allowance.
• Health benefits to include Medical, Dental, and Vision.
• Company match 401k.
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

Pay

Salary Range: $67,700.00 - $115,100.00

Schedule

One day per week

Scope

Onsite support of data mining: Pulling ICD10 code reports, reviewing pathology reports, physician referrals. Oncology (bladder cancer) experience would be beneficial.