Clinical Study Coordinator (Fort Wayne, IN area)

Planet Pharma; Huntington (OH); Sur place; USD 55 000 - 75 000; Plein temps

Résumé du poste

Planet Pharma is seeking a Clinical Research Coordinator to coordinate patient visits in line with ICH-GCP and IRB-approved protocol.

You will screen participants, obtain informed consent, manage data capture, and support sponsor submissions. Strong organizational and communication skills are essential.

Qualifications

• Knowledge and experience in coordinating clinical trials is required.
• Certified Clinical Research Coordinator or Professional (CCRC/CCRP) is preferred.
• Must have excellent organizational skills to independently manage work flow.
• Meticulous attention to detail is required.
• Must be able to take self-motivate and take initiative.
• Must be energetic with the ability to prioritize quickly and multi-task.
• Must have excellent communication skills; both personal and written.
• Must have an excellent teamwork attitude.
• Must demonstrate aptitude for developing new skills.
• Proficiency in Microsoft Office (Word, Excel, Outlook) is preferred.
• Experience with processing laboratory samples is preferred.

Responsabilités

• Reviews and comprehends all study protocols, timelines, inclusion/exclusion criteria, confidentiality and privacy protections.
• Conducts and/or participates in the informed consent process/discussion with research participants, including answering questions and obtaining signatures per SOP.
• Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria.
• Coordinates daily clinical trial activities and patient visits as assigned by research manager.
• Performs sample collection and processes samples per protocol and lab manual guidelines.
• Registers each participant in the electronic data capture (EDC) to ensure billing of study procedures.
• Collects data as required by the protocol and ensures timely completion of Case Report Forms.
• Works with study and clinical teams to recruit eligible candidates to meet enrollment goals.
• Collects documents needed to initiate the study for sponsor submission (e.g., FDA Forms 1572, CVs, licenses, IRB applications).
• Maintains inventory of study supplies and follows Investigational Drug/Device accountability guidelines.
• Creates source documents for data capture per protocol and procedures.
• Establishes and organizes study files and regulatory binders.
• Coordinates monitor site visits and assists with site visit documentation.
• Maintains CVs and training materials per protocol.
• Assist patients with insurance coverage of medication if not covered by sponsor.
• Attends teleconferences and Investigator Meetings as requested.

Connaissances

Clinical trial coordination

ICH-GCP knowledge

Communication skills

Organizational skills

Teamwork

Microsoft Office

Formation

CCRC/CCRP preferred

Outils

Microsoft Office

Description du poste

Position Summary

The clinical research coordinator is primarily responsible for coordinating research patient visits according to ICH-GCP guidelines, and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.

Essential Functions

• Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
• Conducts and/or participates in the informed consent process/discussion with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places per the research SOP. Assures that amended consent forms are appropriately implemented and signed respectively.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility accurately.
• Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Coordinates patient visits as assigned by research manager.
• Performs sample collection per the protocol. Processes samples per the protocol and lab manual guidelines for each study.
• Registers each participant in the electronic data capture (EDC) to ensure billing of study procedures to the appropriate funding source.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms, paper or electronic. Must be attentive to data queries and resolve them within the required timeframe.
• Works with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals.
• As delegated by research manager, collects documents needed to initiate the study for sponsor submission (e.g., FDA Forms 1572, CVs, medical licenses, IRB applications, etc.).
• Maintains adequate inventory of study supplies. If handling investigative drugs/devices, follows the sponsor protocol on Investigative Drug/Device Accountability.
• Documents date of training and signatures of study staff on study specific training log.
• Creates source documents for data capture per study protocol and manual of procedures.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
• Coordinates monitor site visits and assists with preparation of site visit documentation.
• Maintains CVs and training materials per protocol.
• Assist patients with insurance coverage of medication if not covered by sponsor.
• Attends teleconferences and Investigator Meetings as requested by research director.

Job Skills, Education and Experience

• Knowledge and experience in coordinating clinical trials is required.
• Certified Clinical Research Coordinator or Professional (CCRC/CCRP) is preferred.
• Must have excellent organizational skills to independently manage work flow.
• Meticulous attention to detail is required.
• Must be able to take self-motivate and take initiative.
• Must be energetic with the ability to prioritize quickly and multi-task.
• Must have excellent communication skills; both personal and written.
• Must have an excellent teamwork attitude.
• Must demonstrate aptitude for developing new skills.
• Proficiency in Microsoft Office (Word, Excel, Outlook) is preferred.
• Experience with processing laboratory samples is preferred.