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Clinical Research Associate (CRA)

Pharmavise CorporationIndianapolis, IN, us
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We are seeking experienced Clinical Research Associates (CRAs) to provide surge capacity support for ongoing clinical research projects.This role focuses on study maintenance and closeout activitie...[internal_linking.show_more]

Associate-Rehabilitation Clinical Support

Indiana University HealthIndianapolis, IN, United States
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Downtown and Metro Indianapolis) Float staff support coverage for PTO, last-minute call-ins, higher-volume clinics, and front-desk staffing needs.Mileage reimbursements available.Monday-Thursday be...[internal_linking.show_more]

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Clinical Pharmacist

Eskenazi HealthIndianapolis
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The Clinical Pharmacist serves as an essential member of the healthcare team providing expertise in the medication use process and optimizing medication regimens for hospitalized patients.Services ...[internal_linking.show_more]

Clinical Coordinator

TRC Total Renal Care IncPremier Dialysis System
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Cudahy, California, 90201, United States of America.DaVita is seeking a Clinical Coordinator who is looking to give life in an outpatient dialysis center.You can make an exceptional difference in t...[internal_linking.show_more]

Clinical Supervisor

A TEAM YOUTH & FAMILY LLCINDIANAPOLIS, IN, US
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A-Team Youth & Family is committed to delivering compassionate, culturally responsive services to children and families across Indiana.Our work is guided by our CARES values—principles centered on ...[internal_linking.show_more]

Team Leader Clinical

JWM NeurologyIndianapolis, IN, United States
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Team Leader - Clinical Offices.This is a full-time position, days and hours of work are Monday-Friday 8 a.Assists office manager with staff supervision.Assumes all duties of office manager when he/...[internal_linking.show_more]

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Clinical Education Specialist

Indiana UniversityIndianapolis, IN, United States
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Identifies areas for programmatic improvement and develops and implements initiatives to address weaknesses.Establishes program-specific policies and procedures for candidate recruitment.Acts as a ...[internal_linking.show_more]

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Clinical Coordinator

Recovery Centers of AmericaIndianapolis, IN, United States
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A former patient may not be hired at the same location where they were treated until a minimum of one year has elapsed since the completion of their treatment at that location.Former patients may b...[internal_linking.show_more]

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Clinical Associate (Field based)

Stryker Employment Company, LLCIndianapolis, Indiana
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The Clinical Associate delivers high‑quality education, training, and go‑live support for communication solutions within clinical environments.This role partners closely with cross‑functional teams...[internal_linking.show_more]

Clinical Trial Associate

Sumitomo PharmaIndianapolis, IN, United States
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Japan with operations in the U.With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bri...[internal_linking.show_more]

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Clinical Psychologist

Magical Moments ABAIndianapolis, IN
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Magical Moments ABA is dedicated to providing comprehensive, evidence-based therapeutic services to children with Autism Spectrum Disorder (ASD).Our team is committed to creating magical moments ev...[internal_linking.show_more]

Sr. Clinical Research Associate - West Coast - Oncology - FSP

PAREXELIndianapolis, IN, United States
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The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s).The CRA works in close coll...[internal_linking.show_more]

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Clinical Manager

CINQCAREIndianapolis, IN, US
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Why Join Grace at Home? Grace at Home is a provider-led, community-based health and care partner dedicated to improving the health and well-being of those who need care the most, with a deep commit...[internal_linking.show_more]

Clinical Therapist

Boca Recovery CenterIndianapolis, IN, US
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Primary Therapist – Mental Health / SUDs.On-Site – Bloomington, Indiana.Competitive, based on licensure and experience.Founded in 2016, Boca Recovery Center is a nationally recognized provider of m...[internal_linking.show_more]

Clinical Pharmacist

Health & Hospital Corporation of Marion CountyIndianapolis, IN, United States
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Eskenazi Health serves as the public hospital division of the Health & Hospital Corporation of Marion County.Physicians provide a comprehensive range of primary and specialty care services at the 3...[internal_linking.show_more]

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Clinical Liaison

RHI RehabIndianapolis, IN, United States
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The Rehabilitation Hospital of Indiana (RHI) is nationally ranked among the Best Hospitals for Rehabilitation by U.News and World Report for 2024-2025 and the Best Rehabilitation Hospital in Indian...[internal_linking.show_more]

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Clinical Nutrition Manager

Compass Group USAIndianapolis, IN, United States
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Take the next step in your career with TouchPoint as a Clinical Nutrition Manager in Indianapolis, IN!.Monday - Friday, rotating weekends.Must be a Registered Dietitian with the Commission on Diete...[internal_linking.show_more]

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Clinical Nutrition Manager

Compass Group, North AmericaIndianapolis, IN, United States
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Take the next step in your career with TouchPoint as a Clinical Nutrition Manager in Indianapolis, IN!.Monday - Friday, rotating weekends.Must be a Registered Dietitian with the Commission on Diete...[internal_linking.show_more]

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Clinical Trial Label Compliance Associate

Keywords StudiosIndianapolis, IN, US
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Clinical Trial Label Compliance Associate.This role manages CAPAs, deviations, and change controls, and partners with labeling teams to investigate issues, identify root causes, and implement corre...[internal_linking.show_more]

Clinical Research Associate (CRA)

Clinical Research Associate (CRA)

Pharmavise CorporationIndianapolis, IN, us
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Job Description

This is a remote position.

We are seeking experienced Clinical Research Associates (CRAs) to provide surge capacity support for ongoing clinical research projects. This role focuses on study maintenance and closeout activities, ensuring efficient project execution. The CRA will serve as a primary point of contact for study teams and external partners, supporting essential clinical operations without direct involvement in study startup activities.

Key Responsibilities:
Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring.
Act as the primary liaison between internal study teams and external third-party organizations (TPOs).
Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data.
Manage and track clinical queries to ensure timely resolution.
Collaborate with internal teams to align clinical research processes and operational strategies.
Coordinate with business partners and TPOs to facilitate data delivery and ensure compliance with study requirements.

Minimum Qualifications:
Bachelor’s degree in a relevant field.
6+ years of experience in clinical research or a related industry.
Experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Research Assistant.
3+ years of experience in project management or a related role.
Prior experience in pharmaceutical, diagnostics, or CRO environments.
Strong organizational skills with attention to detail.
Ability to effectively communicate with diverse stakeholders.
Proficiency in Microsoft Excel for data tracking and reporting.
Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, Oracle InForm, or similar platforms.
Familiarity with electronic Trial Master File (eTMF) systems, query management tools, and safety reporting databases.
Working knowledge of GCP (Good Clinical Practice) guidelines and regulatory compliance requirements.

In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.

Be part of our network of Subject Matter Experts.

E-Verify Participation:
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.



Requirements
7+ years of experience in GCP auditing, clinical quality, or regulatory compliance Direct experience with FDA BIMO audits or inspections, either: As a former FDA inspector, or As an industry auditor supporting FDA BIMO inspections Demonstrated experience auditing clinical trials under INDs, preferably supporting NDA readiness Strong working knowledge of: FDA BIMO regulations ICH E6 (R2/R3) GCP guidelines Ability to independently lead audits and communicate findings clearly to cross-functional teams Excellent verbal and written communication skills, including delivery of real-time audit feedback Comfortable working in a fast-paced, inspection-style environment