Clinical Research Associate - North Chicago, United States - Spectraforce Technologies

Description

Job Title: Clinical Research Associate (CRA)

Length of Contract: 12+ Months

Location/Site: North Chicago, IL 60064

Minimum Pay Rate: $40

• Monitors activities conducted by study sites as they relate to non-interventional studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard
• Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Provides timely, and complete monitoring reports including actions items and follow-up.
• Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs) and business processes.
• Overviews the overall activities of site personnel over whom there is no direct authority and motivates / influences them to meet study objectives. Proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures audit readiness at assigned sites.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events, if applicable, by site personnel.
• Ensures safety and protection of study subjects through compliance with the study monitoring plan, SOPs, ICH Guidelines, and applicable regulations.
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Manages investigator payments as per executed contract obligations.
• Manages site specific central IRB submissions and approval, including tracking
• Maintenance of site files with in the TMF.
• Manages site specific updates to CTMS systems
• Site feasibility: at the direction of the study management team, evaluates and recommends new/potential investigators/sites on an on-going basis. to assist in the placement of planned study with qualified investigators/sites.

Qualifications

• Bachelor's degree in science or relevant field of study
• 5 years of site Management and Monitoring experience, which includes a period of 2-3 years of non-interventional trial and remote/logic check monitoring experience. Note: both on-site and remote monitoring experience is required.
• Experience with Migraine or Migraine/gepant trials preferred. Neuroscience and pain management experience is a secondary preference.
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with deadlines.
• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
• Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated.
• Ability to use functional expertise and exercise good judgment.
• Demonstrated business ethics and integrity.

Skills Needed

1. Required: Bachelor's degree in science or relevant field of study

2. Required: 3-5 years of US site management & monitoring experience which must include non-interventional studies and remote monitoring/logic check experience. Note: both onsite and remote monitoring experience is required.

3. Required: Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.

4. Strongly preferred: Migraine or Migraine/gepant study experience. Neuroscience and pain management experience is a secondary preference.

5. Strongly preferred: Experience with site specific central IRB submissions/Advarra

Below is the brief introduction of SPECTRAFORCE, the benefits we offer and the disclaimers:

Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams.

We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 130 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation.

SPECTRAFORCE is built on a concept of "human connection," defined by our branding attitude of NEWJOBPHORIA, which is the excitement of bringing joy and freedom to the work lifestyle so our people (and clients) can reach their highest potential. Our entire workflow and teams are trained to cultivate the joy of NEWJOBPHORIA with candidates and employees throughout their engagement with SPECTRAFORCE.

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require reasonable accommodation