Sr.CRA

Sr.CRA

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Summary of Key Responsibilities :

The SCRA is a high-profile role within the department; using their experience as a knowledge resource to help other CRAs develop their skills.

The SCRA will provide expert advice, guidance and general supervision to clinical monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, compliance with client's standard operating procedures (SOPs), clinical monitoring plan, ICH GCP, regulatory requirements, ensuring study completion on time and within budget.

They may be called upon to interact independently with clients not directly involved in their projects, and to assist in some relevant departmental tasks.

The SCRA is an essential member of a Development Innovations project team responsible for the execution of a clinical research project.

The degree of responsibility given to a SCRA shall reflect his/her experience and the level of contribution, which he/she can make to that project.

Duties and Responsibilities:

Duties include but are not limited to:

Reports directly to Manager, CRAs on general issues

Reports to the Project Manager or Project Lead for study specific issues

Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements

Contribute to the departmental on-site Quality Control program by setting a schedule of site assessment visits for the project for agreement with the development innovations monitoring management team, and conducting agreed co-monitoring visits with members of the development innovations monitoring project team

Ensure awareness of project-specific quality and performance standards (within Development Innovations Monitoring Standards) and ensure that these are adequately documented, communicated, and understood

To be accompanied by Project Manager, Project Lead, or CRA Manager on selected visits (qualification, initiation, monitoring, and close out visits.)

To support the development and delivery of department training days

Actively participate in training sessions and workshops, including presenting reports from any conferences attended

Assist in the Investigator selection and qualification process

Assist in the development of patient recruitment strategy

Attendance at Investigator Meetings

Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company SOPs, applicable regulatory requirements and defined quality and performance standards

Ensure site IRB approval is current and all IRB documentation is in order

Maintain site monitoring schedule and serve as the principal point of contact for investigational sites

Document and report on clinical study progress, i.e. patient recruitment and discuss potential opportunities and risks with respective Project Team members

Ensure patient safety is maintained and informed consent procedures are carried out

Provide training and update investigative site team of any changes in study conduct and documentation requirements

Ensure continued acceptability of the investigator, clinical site team and facility

Review clinical data, source documentation, CRF, and investigative site regulatory files

Work closely with data management and site to resolve discrepancies

Ensure investigational product accountability accuracy and oversee investigational product inventory

Liaise with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies

Meet with clinical study sponsor representatives, as requested

Submission of routine monitoring visit reports and follow-up letters as per required timelines

Ensure resolution of issues with investigative sites

Attend meetings as assigned and report on actions

Participate in educational activities and programs

Maintain strictest confidentiality

Work closely and effectively with all other department personnel to ensure appropriate communication and study conduct

Assist other staff as requested and perform other related work, as needed

Function as a mentor for team members

Maintain awareness of current developments in therapeutic area relative to assigned projects

Throughout the conduct of the clinical trial assesses adherence to SOPS, GCP and all applicable regulatory requirements

Travel is required. May also involve travel to meetings or attendance at conferences. Overnight stays may also be required. In addition, weekend and evening sessions may be required depending upon the workload and nature of current programs

Qualifications

Mandatory:

Practices and adheres to the "Code of Conduct philosophy and "Mission and Value Statement

You are expected to complete any training assignments by the due date.

Knowledge of scientific, medical, and regulatory terms.

Knowledge of ICH Guidelines, GCP, and FDA regulations

Understanding of the drug/device development process, including GLP and GMP principles preferred

Computer skills, including MS Word, Excel, Outlook, and PowerPoint; ability to learn new software if required

Professional writing and communication skills

Ability to multi-task in fast paced environment Ability to function in a team environment under time and resource pressures.

Ability to manage, organize, and make decisions.

Ability for working independently with minimal supervision

Detail oriented

Three years direct oncology monitoring experience in Phases l lll

Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and close-out)Demonstrated leadership skills

Preferred:

At least five years direct oncology monitoring experience in Phase l lll in solid and liquid tumor types

Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and close-out)

Demonstrated leadership skills

Previous experience in a Sr. CRA role, preferred

Bachelor's degree