Easter Seals Jobs

Description:

• Conducts pre-study (site qualification), initiation, routine monitoring and closeout visits and ensures these visits are completed according to the Clinical Monitoring Plan(s) and SOPs.

• Trains the study investigators and staff during the SIV and to trial-specific updates, all to industry standards

• Prepares site visit reports and sends confirmation/follow-up letters to sites per the Clinical Monitoring Plan(s)

• Conducts and documents periodic telephone contact with sites in accordance with the Monitoring Plan

• Verifies data entered into the case report forms (CRFs) is consistent with subject clinical records, electronic medical records and source data to ensure accuracy

• Ensures data collection timelines and deliverables are met at assigned clinical sites in accordance with study plans

• Works with Data Management to ensure the query resolution process is followed and completed

• Identifies and reports protocol deviations in accordance with the Protocol Deviation Plans and monitors site submission to the IRB/EC per reporting policies

• Ensures site compliance to SAE reporting policy per protocol and with the Safety Management Plans

• Ensures site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites. Immediately reports non-compliance to the

• CTM and/or head of clinical operations

• Assists the CTM and/or head of clinical operations in the development and implementation of corrected actions for the addressing non-compliance issues at i individual sites and across study, including timely follow-up to routine and for-cause Quality Assurance audits

• Work with investigators on their subject recruitment and screening strategies

• Tracks and reports progress of assigned sites, including study start up, subject screening/enrollment, data collection, adverse event documentation and Frequently Asked Questions document updates

• Partners with the in-house CTAs and/or CRAs in the collection, review, and tracking of essential documents to ensure completeness of both site files and eTMF

• Upload documents into the eTMF and completes coding and QCs as required

• Assists with planning, preparing, distributing and presenting materials for Investigator Meetings and for study-related trainings

• Provides ongoing study-related training (i.e., EDC) and support to site staff as necessary

• Works with Clinical Team in the management of Investigational Product (IP) at clinical sites

• Manages inventory of clinical supplies at assigned sites and monitors the documentation of returns/destruction as appropriate

• May collaborate with the head of clinical operations and/or in-house CTM/CTA/CRAs on the development of certain study-specific plans and/or processes

• Ensure proper collection, storage and shipment of laboratory specimens

• Participates in Clinical Trial Team Meetings

• -Other duties as assigned by the Head of Clinical Operations.

Additional Skills & Qualifications:

1. Bachelor’s Degree (BA/BS) in life sciences or nursing degree

2. Minimum of five (5) or more years of relevant experience in clinical research or healthcare related industry, including a minimum of 2 years direct field monitoring experience, or equivalent combination of education and experience

3. Independent site monitoring experience in all phases of clinical trials (phase 1, 2, and 3)

4. Experience in oncology

5. Experience/training in the following areas: GCP Regulations, ICH Guidelines, Good Quality Practices, 21CFR, HIPAA, Drug Development and Approval Process

6. Proficiency with MS Office

7. Excellent oral and written communication skills including presentation skills

8. Ability and willingness to travel to investigational sites for on-site monitoring visits, up to 70% of the time.

9. Ability to perform virtual monitoring remotely as needed

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.