Clinical Research Coordinator

Istios Health; Worcester (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Istios Health seeks a Clinical Research Coordinator to support on-site trials in a fast-paced research environment. You will coordinate with Principal Investigators, sites and the Istios Health team to ensure protocols, regulatory standards, and data quality are upheld throughout patient participation.

The role includes recruitment, scheduling, data entry into EDC, and maintaining study documentation while ensuring participant safety and regulatory compliance.

Qualifications

• 2+ years of CRC experience in direct patient care
• Knowledge of GCP, IATA and FDA regulations pertaining to clinical trials
• Fluent in written and spoken English
• Ability to complete clinical procedures including phlebotomy, vitals, height, weight, ECGs

Responsibilities

• Coordinate with investigators, sites and Istios Health to ensure trials follow protocol and regulations
• Screen, recruit, and schedule participants
• Maintain regulatory documents and trial logs
• Enter data in the EDC and resolve data queries
• Monitor visits and report deviations
• Manage and report adverse events and study deviations
• Ensure PHI protection and HIPAA compliance
• Communicate with sponsors, CROs and vendors
• Prepare for site initiation visits and investigator meetings

Skills

CRC experience

English fluency

Regulatory documentation

Data entry

Education

Bachelor's degree in health sciences

Tools

EDC systems

IRB portals

Job description

Istios Health is a national, specialty network that strengthens specialty care delivery and expands access to clinical research where patients are treated every day. The company partners with independent specialists, healthcare facilities, and life sciences organizations to connect and scale clinical expertise, real-world evidence, telehealth, and research infrastructure in an integrated model.

Key Responsibilities:

This is a full-time, on-site role.

Under the direction of the Istios Health and the Principal/Sub Investigator(s):

Coordinates with Principal Investigator, local site, and Istios Health to ensure that clinical research trials and activities are performed in accordance with the study protocol, FDA, GCP, ICH Guidelines and Istios Health’s SOPs.

Adhere to clinical trial protocols and coordinate and perform assigned clinical trial activities including, but not limited to:

• Participant pre-screening, recruitment and scheduling
• Complete protocol and trial system training
• Maintenance of regulatory documents
• Conducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study.
• Conducting participant visits
• Entering data in the EDC and resolving all queries
• Updating and maintaining trial logs and participant charts
• Conducting monitoring visits and resolving issues as needed in a timely manner
• Managing and reporting of AEs, SAEs, and deviations
• Maintains adequate inventory of study supplies
• Coordinates appropriate and timely payments to participants
• Manages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor
• Communicate effectively and professionally with coworkers, leadership, trial participants, sponsors, CROs, and vendors.
• Apply good documentation practices in accordance with ALCOA-C standards when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Track screening and enrollment status of patients in site systems and ensure timely communication with patients regarding their study participation
• Understand thoroughly all assigned studies through reading protocols an completing assigned trainings, including preparing for attending site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed
• May set up, train and maintain all technology needed for studies
• Adheres to and supports all Federal regulations and company policies and procedures instituted to safeguard protected health information (PHI)
• Perform other duties as assigned

Ability to perform basic lab and clinical procedures per protocol, such as:

• blood specimen collection (phlebotomy)
• blood pressure
• vitals
• EKGs
• storing and shipping of lab specimens
• accountability of specimens and notification of courier for specimen pick-up

Qualifications:

• College degree (health sciences) preferred or significant relevant experience
• At least 2 years of CRC experience in a direct patient care role
• Knowledge of Good Clinical Practice (GCP), IATA and FDA regulations pertaining to clinical trials
• Fluent in written and spoken English
• Ability to complete clinical procedures including phlebotomy, vitals, height, weight, ECGs