Clinical Research Coordinator II - Lowell General Hospital, Cancer Center - On-Site

Hours: 32 hours weekly, 4 days. Flexible with schedule of 7am-330pm or 830am-5pm during weekdays.

Location: Lowell General Hospital - Main Campus. 295 Varnum Ave, Lowell, MA 01854. (On-site and Hybrid)

Job Profile Summary:

The Clinical Research Coordinator supports clinical trials by recruiting and screening participants, conducting informed consent, and coordinating all protocolrequired visits, procedures, and followup. This role ensures accurate data collection, completion and quality review of Case Report Forms, and timely resolution of data queries. The CRC maintains regulatory documentation, assists with IRB submissions, and adheres to institutional, federal, and GCP requirements. Responsibilities also include arranging and performing studyrelated tests within training scope, monitoring adverse events, managing study supplies, and supporting sponsor site visits. Through strong organizational and communication skills, the CRC ensures protocol compliance, participant safety, and highquality study execution.

Job Overview

This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned.

Job Description

Minimum Qualifications:

1. Bachelor's degree OR High School Diploma or equivalent AND Four (4) years of related experience.

2. Basic Life Support (BLS) certification may be required based on specific role requirements.

3. Two (2) years in research related activities.

Preferred Qualifications:

1. Five (5) years in research related activities.

2. Previous experience in clinical trials.

Duties and Responsibilities: The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.

1. Responsible for assisting in the recruitment of study participants.

2. Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required.

3. Completes follow up with study participants in prescribed settings as required.

4. Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.

5. Complies with all institutional policies and government regulations pertaining to human subjects' protections.

6. Responsible for assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.

7. Performs basic laboratory activities as needed.

8. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.

9. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.

10. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.

11. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.

12. Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation.

13. Maintains inventory of all study supplies.

14. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.

15. Reviews all eligibility and ineligibility criteria in the patient's record.

16. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.

17. Conducts a QC check of completed CRFs prior to submission for data entry.

18. Coordinates resolution of all data queries.

19. Completes data entry as warranted.

20. Maintains regulatory binders, case report forms, source documents, and other study documents.

21. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.

Physical Requirements:

1. Typical clinical and administrative office setting.

Skills & Abilities:

1. High degree of organizational talents, data collection and analysis skills.

2. Requires meticulous attention to detail.

3. Excellent computer skills including word processing.

4. Ability to prioritize quickly and appropriately.

5. Excellent communication and interpersonal skills.

6. Systematic record-keeping.