Clinical Research Coordinator

Job Description

*Part-Time Paid Position*

Compensation Commensurate to Experience

Starting $19-$24/Hour As per Experience

POSITION SUMMARY

Under the direction and supervision of the Ash Research Clinic Site Operations Manager, this position facilitates all implementation phases of new studies as well as the ongoing coordination and maintenance of open and closed studies. The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies. The position works closely with the Principal Investigator, members of the medical team, study sponsors and monitors, and the institution (Ash Research Clinic) to support and provide guidance on the administration of the compliance, personnel and other related aspects of all ongoing clinical studies.

REQUIRED EDUCATION AND EXPERIENCE:

· B.S. in Life Sciences is required

· At least one year of previous experience in the field of clinical research as a Study Coordinator on Industry-Sponsored clinical trials or relevant patient in-clinic experience.

· Good understanding of ICH-GCP, Declaration of Helsinki and knowledge of regulatory requirements

· Previous experience working with an electronic data capture system and CTMS system

· Ability to read, write, and interpret the English language

· Experience with Data Entry, Biospecimen Handling Processing and Shipping, and Independently managing a clinical research site location is REQUIRED.

JOB KNOWLEDGE AND SKILLS:

· Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors

· Knowledge of medical and clinical research terminology

· Very good knowledge of the Microsoft Office Suite

· Excellent organizational skills to independently manage workflow

· Ability to prioritize quickly and appropriately

· Ability to multi-task

· Meticulous attention to detail

PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:

· Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study

· Schedules study participant appointments and serves as the patient liaison to the PI and other members of the study team

· Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protection

· Coordinates approval of new study agreements and contracts

· Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits

· Completes case report forms and assists the PI and Sub-Investigators in queries resolution

· Manages all activities related to vendors in a clinical study (Clinical trial supplies

vendor, Central readings vendor, Central laboratory, other electronic systems used within a study)

· Responds to data clarification requests in a timely manner – within 5 business days.

· In case of need attends Investigator meetings requiring travel and reports pertinent information back to research team members

· Coordinates with PIs and all staff members to help ensure that clinical research and related activities are performed in accordance with country regulations, Ash Research Clinic and sponsor’s policies and procedures

· Assists the PI in the development and maintenance of materials and tools necessary to appropriately train individuals involved in the conduct of the study around topics related to (but not limited to) protocol requirements, schedule of visits, logistics, communication.

· Maintains study-specific documentation

· Coordinates and facilitates regulatory inspections and audits

· Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations

· Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis

· Ensures that all materials for each clinical trial protocol are available for subject enrollment

· Works collaboratively with the other members of the clinical research team to ensure all protocols are followed and that there is timely documentation and submission of study data

· Performs specimen processing and shipment of biological specimen duties, if delegated

· Assists with study materials logistics and management including but not limited to, the informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs

· Establishes and organizes study files, including but not limited to, regulatory binders, study specific subject source documentation files and other materials as required

· Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.

Why Work Here?

ASH Research Clinic stands for Advancing Science & Healthcare - we are the ideal place to build a career in clinical research!

AddressAsh Research Clinic LLC

1255 E Grand River Ave

Howell, MI

USA