Research Associate Clinical I Jobs in Pulaski, Arkansas

Bachelor’s degree plus 3-5 years clinical research experience w/demonstrated proficiency in study planning/development, study coordination/management, and/or data collection, or

Associate’s degree plus 5 years clinical research experience w/demonstrated proficiency in study planning/development, study coordination/management, and/or data collection, or

High School diploma/GED plus 7 years clinical research experience w/demonstrated proficiency in study planning/development, study coordination/management, and/or data collection

Bachelor’s degree plus 5 years clinical research experience w/demonstrated proficiency in study planning/development, study coordination/management and data collection

Knowledge and skill with word processing, spreadsheet, database, and e-mail computer software (e.g., Microsoft Word, Excel, Access, Outlook)

UAMS offers amazing benefits and perks

Conduct all types of visits including, qualification, initiaiton, monitoring and close out

Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff

Ensure good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements

Minimum 1.5 years monitoring experience

Strong verbal and written communication skills

8-12 days on site per month

Required Knowledge, Skills, And Abilities

Assists with the preparation of summary documents and reports in conjunction with Program Manager and Project Manager.

Strong communication, qualitative and quantitative analytical skills.

Experience within Health Services Research preferred.

Experience in biostatistics and epidemiology.

Minimum of 0-2 years' experience required.

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.

Assist in the monitoring and resolution of data discrepancies resulting from discrepancy listings generated from clinical data management

Knowledge of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred

Follow up with outstanding documentations from clinical sites to complete site qualification

Manage site communications, generate site and patient reports and queries, and verify reports prior to distribution to clinical sites and sponsors

Phantom data analysis and data entry

Ensure IQC data is collected and maintained according to applicable SOPs and/or study protocol requirements

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.

Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.

1-2 years of research experience

Collects and records study data. Inputs all information into database.

Assists in preparing grant applications, IRB/GCO for submission and filings.

Secures, delivers and ships clinical specimens as required by the protocol.

Bachelors or Masters degree in Science or closely related field.

· 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.

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.

Knowledge of clinical research study processes, protocol management, and regulatory guidelines.

Proficiency in medical terminology and computer skills.

Strong attention to detail and excellent written and oral communication skills.

Ability to manage multiple deadlines and prioritize tasks effectively.

Minimum three years of experience in conducting clinical research studies or verifying clinical data.

Knowledge across multiple therapeutic areas, including blood and marrow transplant.

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

Assists with coordination and management of clinical trials including communication with Sponsors.

Under direct supervision of the Principle Investigator(s), obtains informed consent and educates participants regarding study requirements.

0-2 years of experience in a hospital or academic (research) environment preferred.

Excellent written and oral communication skills

Collects and records study data; inputs all information into database.

Secures, delivers and ships clinical specimens as required by the protocol.

Excellent organizational, time management, and problem-solving skills.

Support and comply with the company’s Quality Management System policies and procedures.

Basic proficiency of ICH GCP and monitoring practices with a track record for ensuring quality data and performing outstanding site management.

Supports the Clinical Study Manager to develop study-specific training materials.

Conducts thorough site qualifications visits. Ensures all required information concerning site/staff qualifications is clearly documented and communicated to project teams.

Works with clinical study manager to manage vendors (ie. Central Laboratory, CRF printers, CROs, etc).

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

Obtain informed consent and educate participants regarding study requirements.

1-2 years clinical research experience

Pristine attention to detail and ability to manage time appropriately, able to multitask in a fast-paced environment

Collect and record study data and input all information into a database.

Assist in IRB/GCO applications as needed.

Collect, process, deliver and ship clinical specimens as required by the protocol.

Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.

1-2 years of research experience

Collects and records study data. Inputs all information into database.

Assists in preparing grant applications, IRB/GCO for submission and filings.

Secures, delivers and ships clinical specimens as required by the protocol.

Bachelors or Masters degree in Science or closely related field.

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