Senior Clinical Research Associate - Midwest
Senior Clinical Research Associate (CRA)-Midwest will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites (Midwest) to support ongoing and future OncoC4 clinical trials of novel immune therapies for various cancers.
CLINICAL SITE MONITORING AND MANAGEMENT
- Develops strong investigative site relationships and ensures continuity of investigative site relationships through all phases of the trial
- Conducts site visits including but not limited to Pre-study visits, initiation visits, interim monitoring visits, close-out visits to ensure compliance with protocols, Sponsor SOPs, ICH/GCP and all applicable regulations
- Performs remote and on-site monitoring & oversight activities using various tools to ensure data generated at the site are complete, accurate, and unbiased; subjects' rights, safety, and well-being are protected
- Collects, reviews, and monitors required regulatory documents for study start-up, study maintenance, and study close-out
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, missing data and data queries, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance
- Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per protocol to upper management
- Performs investigational product accountability through physical inventory and record review
- Participates & provides inputs on site selection activities
- Supports audit/inspection activities as needed
- Work with in-house Clinical Trial Assistant to collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.
- Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
- Demonstrated high level of monitoring skill with independent professional judgment.
- Demonstrated understanding of medical/therapeutic area knowledge (oncology) and medical terminology
- Knowledge of e-TMF and CTMS set up and maintenance processes
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
- Excellent written and verbal communication skills including good command of English
- Proven skills in site management including independent management of site performance and patient recruitment
- Effective time management and organizational skills
- Ability to establish and maintain effective working relationships with coworkers
- Bachelor's degree in Sciences from an accredited institution with strong emphasis in science and/or biology
- Minimum of 3 to 4 years of clinical monitoring and direct site management experience in a bio/pharma/ Clinical Research Organization
- Experience monitoring oncology trials is required
- Applicants may be eligible to work remotely depending on location
- Ability to travel domestically approximately 50% of working time
- Current driver's license preferred
Please send CV and any inquires to email@example.com and firstname.lastname@example.org.