Clinical Research Coordinator - 246112
MedixValparaiso, IN, USjob_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionIndependently manage all aspects of clinical trials in accordance with protocols, GCP, ICH guidelines, and organizational SOPs. Oversee trial activities from start-up through close-out, including vendor coordination, subject recruitment, scheduling, protocol training, regulatory document collection, study visit execution, data entry, query resolution, and safety event reporting. Apply project management principles to identify risks, improve processes, and ensure quality in trial conduct. Develop and implement research strategies and administrative processes to support successful protocol execution. Communicate professionally with internal teams, study participants, sponsors, contract research organizations (CROs), and external vendors. Ensure accurate and timely documentation of study data, adhering to good documentation practices and sponsor data systems. Protect the confidentiality of patient health information and sensitive sponsor and organizational data. Monitor and escalate patient safety concerns, including reporting adverse events, serious adverse events, and protocol deviations per study guidelines. Ensure timely data entry into sponsor platforms and resolution of any outstanding data queries. Confirm staff training and delegation are appropriate and properly documented. Prepare, collect, and submit regulatory documents to sponsors and Institutional Review Boards (IRBs) in accordance with protocols and regulatory requirements. Evaluate potential study participants through pre-screening calls and in-person assessments. Assist in the creation and execution of recruitment plans developed by the clinical research team. Maintain thorough understanding of assigned studies, including timelines, endpoints, vendors, patient populations, and overall protocol design. Demonstrate understanding of disease areas under investigation and the significance of key clinical data points. Collaborate with the research team to develop quality control processes to ensure data accuracy and monitor readiness. Perform clinical procedures within scope of practice (e.g., phlebotomy, ECGs, lab processing, medication preparation / administration, Fibroscan). Carry out additional responsibilities as assigned. Bachelor's degree with a minimum of 2 years of relevant experience as a CRC Associate's degree with a minimum of 4 years of relevant experience as a CRC High school diploma or technical certification with at least 6 years of relevant experience as a CRC Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances) Health Benefits / Dental / Vision (Medix Offers 6 different health plans : 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s).) 401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1 / 1, 4 / 1, 7 / 1, and 10 / 1) Short Term Disability Insurance Term Life Insurance Plan
Important Details :
- Candidate MUST be LOCAL, NOT open to relo candidates
- Candidate MUST have experience with phlebotomy and administering injections
- 90 days CONTRACT
Job Summary
The Clinical Research Coordinator II is responsible for the coordination and management of multiple clinical trials from study initiation through close-out. This role ensures compliance with study protocols, Good Clinical Practice (GCP), and internal standard operating procedures (SOPs).
Key Responsibilities
Qualifications
Education & Experience Requirements :
One of the following :
Benefits :
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Clinical Research Coordinator • Valparaiso, IN, US