Field Clinical Research Associate Jobs in Union, Arkansas

Minimum of four (4) years of experience in clinical research specifically in Ophthalmology surgical medical devices.

Experience in glaucoma devices is strongly preferred.

Knowledge of medical and ophthalmology terminology

Remotely monitor data and support clinical sites for protocol compliance and recruitment activities

Manage clinical trial close-out activities, including return of investigational product, final reconciliation of all required documentation, and EDC close-out

** Candidates must have experience in Ophthalmology Clinical Research trials to be considered!

·3+ years of clinical monitoring or site management experience.

Delivers high quality and timely reports following each site management or site monitoring visit.

May include managing query resolution process with clinical sites and data management groups.

·Thorough knowledge and understanding of ICH/GCPs and applicable regulatory requirements.

·Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.).

Prepares for and conducts site qualification and site initiation, visits. May also include interim and closeout monitoring visits.

Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.

Excellent time management and social skills

Minimum of 2 years of active independent field monitoring experience - all types of visits.

Strong interpersonal, written, and verbal communication skills within a matrixed team.

Experience working in a self-driven capacity, with a sense of urgency and limited oversight.

Benefits Of Working With Parexel FSP

Ability to independently prioritize tasks with excellent time management skills.

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans.

Perform other duties as assigned by management.

Excellent verbal and written communication skills and conflict resolution abilities.

Oversee and conduct monitoring activities, including remote monitoring and risk-based monitoring.

Lead assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.

Utilize systems and technology for account management tasks

Remote work-from-home position with flexible schedules

Comprehensive benefits package including medical, dental, vision, and life insurance

Excellent communication skills, both written and oral

Basic knowledge of Microsoft Office Suite and Windows operating system

Strong problem-solving and conflict resolution skills

Extensive knowledge of clinical trial procedures, GCP, and regulatory requirements

Excellent attention to detail, strong multitasking abilities, and effective communication skills

Experienced CRA Consultant - Midwest Region | Join a Leading Medical Devices Research Team!

Manage adverse events and ensure proper reporting according to industry standards

Stay abreast of the latest clinical trial processes, GCP, and regulatory requirements

Minimum of 5 years' experience as a CRA, preferably in medical devices

SPECIAL SKILLS, ABILITIES, AND REQUIREMENTS

Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements

Supports device management, including device accountability, at the site and Sponsor level

Advanced knowledge and experience with GCP/ICH and local regulations

Experience in web-based data collection applications, knowledge of key areas of Compliance

Previous field monitoring experience required, monitoring of device trials in the cardiovascular space preferred

Education, Qualifications, Skills and Experience

• Good financial management skills.

• Basic change management skills.

• Support SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

• Excellent understanding of Clinical Study Management and study start-up

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.

Ensure protocol and regulatory compliance, quality of data, and clinical site staff training, manage study sites

Knowledge of GCP and ICH guidelines required

The CRA should have the following Qualifications…

Bachelor’s degree in a relevant scientific discipline or equivalent

Job Title: Contract Clinical Research Associate

Salary: $70 USD - $85 USD Per Hour

Assist the Senior Clinical Trial Manager in the review of Informed Consent Forms and other essential study documents

Certification as a Clinical Research Associate or Clinical Research Professional is highly desirable

3+ years clinical trial site monitoring experience in a biotech, pharmaceutical and/ or CRO company

Good understanding and working knowledge of clinical research and phases of clinical trials

Strong written and oral communication skills

Knowledgeable of Electronic Data Capture and other IT systems (CTMS, Microsoft Office, etc.)

We are looking for professionals with these required skills to achieve our goals:

• Experience in the clinical development/drug development/OTC Drug development process.

• Experience in the Pharmaceutical or healthcare industry. Consumer Health care experience is greatly preferred.

• Experience in regulatory / health authority interactions on clinical designs/submissions.

• Experience within Pain relief or OTC Drugs

• Demonstrated experience representing an organization with external stakeholders.

Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready

Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines

Contributes to CRA Team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices

Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

Escalate any site issue to the Clinical Trial Manager and/or study team, as needed.

Develop in-depth knowledge in relevant indications and clinical study methodology.

BA degree or RN or higher, preferentially in sciences/medical sciences, or equivalent experience.

At least 5 years of clinical monitoring experience.

At least 8 years of experience in the pharmaceutical industry or clinical research site-based experience.

Knowledge of ICH GCP guidelines.

At least two years of experience as a clinical research associate

Excellent writing, editing, and communication skills

Strong Administrative and Organizational skills to support several team members

A bachelors degree in Health Sciences, Nursing or Medical Biotechnology, or Biological Sciences

Familiarity with various computer document formats, styles, and standards

· Collecting, analyzing, and recording data

The Clinical Research Intern will apply analytical, project management skills and enthusiasm for healthcare and commitment to improving healthcare through research.

The candidate will Product practical experience within the Clinical Research operations at ***.

Complies with established policies, health and safety regulations and requirements, procedures, and department objectives.

Bachelor's Degree in biological or life sciences or health related field OR attending/completed a clinical research certification program.

Proficient computer skills using Microsoft Office products.

May assist with follow up and closing of clinical studies.

Able to manage multiple and competing priorities through effective organizational management skills.

Effective interpersonal skills; able to build effective relationships with study management team colleagues and business partners.

Excellent time management skills; able to accomplish established goals efficiently.

Supply chain management support may include:

Support Trial Management team member with assigned study specific projects and tasks.

Two years Clinical Research work experience, or relevant experience

Clinical Trial Collaboration: Work alongside our clinical team, focusing on site qualification, initiation, management, and data integrity.

Data Management: Oversee data activities, generate, and resolve queries, and report on study metrics including enrollment and adverse events documentation.

Regulatory Oversight: Manage investigational product accountability, monitor IRB requirements, and ensure prompt processing of regulatory documents.

Bachelor’s degree in a medical/scientific field, with 4+ years of clinical research experience (Master’s degree can substitute for 1 year).

Strong organizational, multitasking, and relationship-building abilities.

Effective communication skills and keen attention to detail.

5+ years of CRA experience.

3+ years of experience working on oncology studies.

BS in a relevant scientific discipline.

Ability to travel and be on-site. (Austin, TX or Portland, OR).

6-month contract. - 40 hours per week. - Monday to Friday.

Austin, TX or Portland, OR

Effective time management skills required with a demonstrated ability to assess and prioritize opportunity required.

Market knowledge and experience selling to OB/GYN or MFM strongly preferred.

Minimum three years’ physician sales experience in diagnostic laboratory business (preferably in a genetics laboratory).

Excellent organizational and communication skills (written and verbal) with demonstrated ability to effectively present to both internal and external customers.

Increasing revenue and driving market development through direct sales to individual MFMs, Ob/Gyns and Genetic Counselors.

Sales efforts include effective prospecting, cultivating and maintaining key relationships.

• Maintains on-going professional education on clinical trials and research

• Minimum requirement: master’s degree in nursing/Healthcare related field

• Clinical work experience in oncology

• Excellent organizational and communications skills, with team-player proven ability to meet project deadlines

• Knowledge of data analytics

• Serves as a liaison to industry sponsored, consortium and Investigator initiated Brain Tumor Trials

Good understanding of Clinical Study Management including monitoring, study drug handling and data management

1.5+ years of CRA experience in Cardiovascular/Metabolic, Respiratory and/or Immunology therapeutic experience

Fluent knowledge of spoken and written English

Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP

Good knowledge of relevant local regulations

Good medical knowledge in relevant AZ Therapeutic Areas