Associate Clinical Research Specialist Jobs in Iowa

Familiar with industry CTMS and data management systems

Provides site level management for established protocols and portfolio under general supervision

Project Management - Communicates changes and progress; Completes projects on time and budget.

Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues

Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

Excellent communication and interpersonal skills

Shipping/ labeling/Site Management and Team meeting facilitator

Database Lock (listing review as needed/ Data query & resolution/Source data verification – onsite or remotely)

Read more about our employee benefits.

Generation of Study Documents (Clinical Monitoring Plans/ Informed Consents/ data source work sheets/Device accountability/training slides and work instructions)

Site start up to Site Activation (SA) to include Investigator Site File/Inventory and Device

Study Duration (Enrollment tracking/Key Performance Indicators/Adverse Events/ Serious Adverse Events)

10+ years of relevant experience in Enterprise sales or business development focused on SaaS, Real Word Data and scientific services.

Experience selling complex solutions and driving significant revenue growth.

Excellent communication, presentation and analytical skills.

Proven ability to work with complex, technical software and service offerings, and processes involving multiple stakeholders.

Experience with Google suite of productivity applications (gMail, gCalendar, Sheets, Slides, Docs).

Build and maintain strong relationships with customers and partners.

Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.

Effective time and financial management skills.

Alternatively, you should have an equivalent combination of education, training and experience

A Bachelor's degree in a health care or other scientific discipline or educational equivalent

Good therapeutic and protocol knowledge as provided in company training.

Written and verbal communication skills including good command of English language.

Alternatively, you should have an equivalent combination of education, training and experience

A Bachelor's degree in a health care or other scientific discipline or educational equivalent

2 years of clinical research coordinator experience strongly preferred

While projects vary, your typical responsibilities might include:

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation

Protocol Development/Management And Study Responsibilities

Oversee operations of clinical research studies including the recruitment, coordination, and scheduling of subject participation and procedures per protocol requirements.

Collect and manage data in clinical trials using a variety of data programs including REDCap data capture.

Good Written And Verbal Communication Skills Are Required.

Participate in the development of the general research goals and in the planning and implementation of the clinical trials.

Coordinate services/referrals as appropriate with other departments participating in the clinical research as appropriate.

Must have at least 6+ years of independent monitoring experience

Must have knowledge of applicable clinical research regulations (FDA, GCP, ISO)

Must have direct sponsor experience at a pharma or biotech

Strong communication and organizational skills required

Ensures monitoring, monitoring report review/finalization, event reporting and all other monitoring commitments are performed in accordance with the study monitoring plan.

Conducts a thorough comparison (monitor) of case report forms against medical records on complex trials at multiple sites.

Interact with data management and study sites with generation and reconciliation of queries in order to meet business timelines

Provide answers to common protocol study related questions under the supervison of the Clinical Director or Associate Trial Manager

Assist in the identification and qualification of study sites

Minimum of 3 years experience as a CRA

Preferred: minimum of one year research and development experience

Basic knowledge in the areas of microbiology, immunology or molecular biology and biochemistry as related to infectious diseases

Strong interpersonal, collaboration and time management skills

Verifies proper management and accountability of Investigational Product (IP).

In-depth knowledge and practical utilization of ICH- GCP and applicable regulatory requirements

Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.

May serve as preceptor, providing training to less experienced clinical team members

2 years of experience supporting clinical trials including 1 year of on-site monitoring experience

Ensure subject safety in all areas of clinical research, following procedures to report SAEs and UADEs to clinical and regulatory management.

Significant industry experience in clinical research, three to five+ years as a CRA performing field-based monitoring preferred.

Demonstrated knowledge of FDA regulations and ICH – GCP guidelines.

Ability to effectively manage a study from start to finish.

Excellent communication skills required to effectively work with all individuals including the sales force and staff at study sites.

Proficient computer skills using Microsoft Office products.

Strong interpersonal, collaboration and time management skills

Verifies proper management and accountability of Investigational Product (IP).

In-depth knowledge and practical utilization of ICH- GCP and applicable regulatory requirements

Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.

May serve as preceptor, providing training to less experienced clinical team members

2 years of experience supporting clinical trials including 1 year of on-site monitoring experience

Knowledge of ICH and local regulatory authority regulations regarding drug trials

Benefits of Working in ICON:

Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e.

What do you need to have?

Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements

Thorough knowledge of monitoring procedures; Basic understanding of the drug accountability process

Good planning, organization and problem-solving abilities; Ability to work with minimal supervision

Organize and make presentations at Investigator Meetings

Participate in the development of protocols and Case Report Forms as assigned

Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

Prepares and negotiates study and vendor contracts, as well as awards clinical research studies within the contract management system.

License or Certification required by statute or regulation

License or Certification required by the Department

Liaises and establishes effective relationships with sponsors, study teams, and ancillary stakeholders.

Ensures alignment of contract consultation process for teams and study are properly aligned to the critical path for site activation

Prepares and reviews budgets, templates and supporting documents.

BS/BA in Life Science or Nursing (or equivalent foreign education / experience) required

Perform on-site and remote monitoring activities from study start-up through close-out

Perform all duties and responsibilities in adherence to protocols, FDA regulations, ICH/GCP guidelines, and company / client SOPs

Extensive knowledge of FDA regulations and GCPs

Computer proficient with EDC experience

Excellent verbal and written communication skills