Clinical Research Coordinator II - Biospecimen

hhccareers; Hartford (CT); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Competitive benefits program

Job summary

Hartford HealthCare is seeking a Clinical Research Coordinator in the Cancer Clinical Research Office (CCRO) to support oncology studies involving biospecimens. You will screen and consent patients, collect blood and tissue samples, and perform data entry in sponsor systems.

Work with trial coordinators and pathology for specimen handling, ensure compliance with regulatory requirements, and assist with audits and billing inquiries. Travel between Greater Hartford sites may be required.

Qualifications

• Bachelor’s degree in Nursing, Pharmacy, or Healthcare related.
• Minimum of 2 years of relevant clinical research experience.
• Familiar with Epic or other electronic medical records.

Responsibilities

• Coordinate and facilitate biospecimen studies in oncology: screening and consenting patients, collecting blood and other specimens.
• Work with trial coordinators on specimen collection, processing, shipping and timed assessments; coordinate with pathology and sponsors for archived tissue submissions.
• Review cancer clinical trial protocols and laboratory manuals for planning and training needs.
• Ensure compliance with federal regulation and guidelines governing clinical research including informed consent; monitor protocol for safety and compliance; data entry and sponsor monitoring.
• Document data into sponsor electronic data capture systems and complete data entry within timelines.
• Prepare study calendars and materials; maintain participant tracking/enrollment logs.
• Performs research blood draws as needed.
• Assist regulatory staff with study reporting requirements and IRB policies.
• Assist CCRO with clinical trial billing queries.
• Coordinate preparation for audits and manage laboratory supplies.

Skills

Clinical data collection

Phlebotomy

Epic EMR

Excel

Education

Bachelor’s degree (in Nursing, Pharmacy, or Healthcare related)

Tools

RedCap

Medidata

RAVE

Excel

Job description

Work where every moment matters.

Every day, more than 40,000 Hartford HealthCare colleagues come to work with one thing in common: Pride in what we do, knowing every moment matters here. We invite you to become part of Connecticut’s most comprehensive healthcare network.

The Hartford HealthCare Cancer Institute focuses on offering our cancer patients an unparalleled network of coordinated services– all under one roof. Our system of care includes a truly integrated team with the most talented, experienced, and compassionate caregivers and physicians, backed by the latest cutting-edge technology.

The Clinical Research Coordinator l of Cancer Clinical Research Office (CCRO) is an integral member of the research team. In compliance with all regulatory, institutional and departmental requirements performs patient screening, consent, data collection and data entry for research protocols, and projects within Hartford Healthcare Cancer Institute. This position specifically supports studies that involve collection of biospecimens such as blood and leftover surgical tissue.

Position Responsibilities

• Coordinate and facilitate the appropriate conduct of biospecimen studies in oncology: screening and consenting patients, collecting blood and other specimens from study patients.
• Works with clinical trial coordinators on research specimen collection, processing, shipping and timed assessments. Coordinates with pathology and study sponsors for submission of archived surgical tissue samples.
• Reviews cancer clinical trial protocols and laboratory manuals for logistical planning and training needs.
• Conduct studies in accordance with federal regulation and guidelines governing clinical research including informed consent; continuous monitoring of protocol for compliance and patient safety; source document review; data entry; sponsor monitoring; processing, storing and shipping of research specimens in accordance with study laboratory manual and IATA regulations.
• Document relevant data collections into various sponsor electronic data capture systems and complete data entry within protocol timelines.
• Prepare study calendars and materials; maintain participant tracking logs and screening/enrollment logs.
• Performs research blood draws as needed.
• Assist regulatory staff with study regulatory reporting requirements and IRB policies for protocol deviations, safety reporting and continuing reviews.
• Assist research account specialist of CCRO with clinical trial billing in the resolution of related queries.
• Assist/coordinate preparation for internal and external audits.
• Provides inventory management of research laboratory supplies.

Education:

• Bachelor’s degree (in Nursing, Pharmacy, or Healthcare related).

Experience:

• Minimum of 2 years of relevant clinical research experience.
• Familiar with basic laboratory principles and safe handling of blood and other biological specimens.

Knowledge, Skills and Ability Requirements:

• Demonstrated clinical competency with patient related measurements and with a high degree of accuracy with respect to documentation and data collection.
• Review patient medical charts – familiar with Epic or other electronic medical record
• Phlebotomy trained or willing to train.
• Ability to work with spreadsheets (such as Excel), familiarity with databases (ex: RedCap, Medidata, RAVE, etc.) and querying.
• Experience in preparing and completing Case Report Forms (CRF’s), eligibility checklist and other relevant clinical research documentation.
• Excellent interpersonal skills are required for working with the study participants and working as a member of a highly integrated team.
• Ability to travel between clinical sites in the Greater Hartford area, whenever required.

We take great care of careers.

With locations around the state, Hartford HealthCare offers exciting opportunities for career development and growth. Here, you are part of an organization on the cutting edge – helping to bring new technologies, breakthrough treatments and community education to countless men, women and children. We know that a thriving organization starts with thriving employees-- we provide a competitive benefits program designed to ensure work/life balance. Every moment matters. And this is your moment.