Associate Clinical Research Specialist 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.

Excellent interpersonal, oral, and written communication skills in English

Superior organizational skills with attention to details

5+ years of experience as a Clinical Research Associate

Experience in CNS is required

Conduct study initiation visits (SIVs)

Ability to work with little or no supervision

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.

· Prepares and attends assessment visits with less experienced CRAs, as required.

· Sound knowledge of medical terminology.

· Excellent communication in English in both written and verbal skills.

· Excellent interpersonal and organizational skills.

· Ability to manage more than 1 study simultaneously.

· Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.

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

Skilled in calendar management and scheduling

Knowledge of internet marketing including email and forum management

Possess strong administrative and organizational skills

Ability to multitask and perform data entry and analysis

Experience in minutes and notes taking

Knowledge of telephone and conference calling

Develop and implement contract management policies and procedures

Manage contracts, global IP portfolio, and litigation matters

Register copyrights and manage annuity payments

Manage all aspects of legal holds and maintain reporting on litigation matters

Manage relationship with insurance providers about claims

Completion of paralegal school/certification highly desired

Skills & Experience (top 3 skills):

•Quality Management System/Regulatory Compliance Program

Location:100% remote – EST support Henry Ford in Detroit (Remote)

Work Experience (do not edit):

•Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations

Insert major accountabilities in chart

• Great career progression opportunities into management roles.

• Must be detail-oriented and efficient in time management;

This organisation will offer you the following and much more:

• Limitless training and development programs to benefit career advancement

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol

• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement

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

Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.

Must have knowledge in reference to good clinical practices regulations and standard operating procedures.

The job requires the ability to make judgements based on practice and previous experience.

Preferred, experience with electronic file system, Medidata and SharePoint & Smartsheet.

Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.

Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings.

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.)

Excellent planning and organizational skills with effective time management

Ability to work in a fast-paced environment and to comply with regulatory requirements and deadlines

1 year of experience working in Clinical Research required

Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English

Document site visit findings via written reports

Assess, monitor, and train study site staff on protocol adherence as required

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.

Responsible for implementing the stategic initiatives established by the business and the department.

Responsible for tactical components of creating and driving customer-centric relationships cross-functionally to support product developments throughout the product(s) life cycle.

Subject matter expert (SME) in the technical application of product portfolio.

Travel up to 30% of the time domestically and / or internationally.

Responsible for the execution of all aspects of clinical studies including but not limited to: