Job Title: In-House CRA
Reports To: Clinical Monitoring Director Level
Location: Deerfield, Illinois (candidate must have ability to work in-office)
Summary of Responsibilities
An In-house Clinical Research Associate will work closely with the Lead CRA and Clinical Research Associates by providing centralized support to regional team members, assisting with the preparation, organization and follow-up of investigator and study site selection, site communications and clinical monitoring tracking both at a local and international level. This role will involve:
- Support Site Identification, Recruitment & Qualification
- Be first line of contact to direct or address non-medical site questions
- Perform study tracking to ensure that all study files and documents are accurate, current and complete.
- Perform essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs.
- Provide general support to the Lead CRA and CRA in order to manage the investigator sites and ensure compliance
- Develop or contribute to newsletters for assigned studies based on information provided by Project Team.
- Maintain FAQ list for assigned trial(s)
- Confirm and track that all key site personnel have project specific training.
- Document site and sponsor contact and study interactions in a timely and professional manner.
- Assist with resolution of investigational site/data queries.
- Liaise with project team members regarding study site issues.
- Provide quality review of the informed consent template.
- Track submission to and approval from IRB, 1572 changes (including obtaining medical licenses and CVs related to these changes) correspondence, site changes.
- May provide study-specific direction, training and mentoring to CRAs, and support staff as appropriate, and may provide guidance to other team members.
- Travel to sites and meetings as needed.
- Other duties as assigned and may change with change in studies/Advanced Clinical needs.
- Education: Bachelor’s degree, in biological sciences or healthcare
- Experience: 3+ years related experience. Clinical trial experience level experience (CRO, healthcare settings and industry experience are acceptable). Prefer scientific discipline and multiple therapeutic experiences.
The candidate must have:
- Excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail.
- Strong computer proficiency in MS Office including Word, Excel, and PowerPoint.
- Strong critical thinking, problem solving and analytical skill sets.
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
- Excellent organizational and record-keeping skills.
- Ability to maintain excellent working relationships with a broad range of trial staff.
- Knowledge of GCP as relates to clinical trial management
- Ability to work well in a team environment but also independently without significant oversight. Flexibility in work hours and readiness to travel.
This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).