Clinical Research Coordinator II

Tufts Medical Center, Inc.; United States; On-site; USD 48,000 - 60,000; Full time

Job summary

Tufts Medical Center, Inc. seeks a research assistant to support planning and implementation of clinical studies under the Principal Investigator. The role includes participant recruitment, data collection, and regulatory duties within a clinical research environment.

The ideal candidate will have a bachelor’s degree or equivalent with multiple years in research activities, and may require BLS certification. Strong organizational and communication skills are essential for success.

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.

Responsibilities

• Assist in recruitment of study participants.
• Screen and enroll participants for eligibility by phone, clinic, or other settings.
• Complete follow-up with participants per protocol.
• Abstract source documents and complete case report forms per best practices.
• Adhere to institutional policies and government regulations on human subjects protection.
• Assist with IRB requirements and annual reviews as needed.
• Perform basic laboratory activities as required.
• Maintain patient confidentiality per HIPAA and secure study data per FDA GCP.
• Identify protocol compliance issues and communicate with investigator and sponsor as needed.
• Arrange tests and procedures per protocol and report results to the investigator.
• Conduct required tests (e.g., EKGs, Walk tests) as training allows.
• Coordinate site visits with study sponsor to review documentation.
• Maintain inventory of study supplies.
• Assess potential patients for protocol eligibility.
• Review eligibility criteria in patient records.
• Verify information with physician and obtain informed consent signatures.
• QC check CRFs before data entry submission.
• Coordinate resolution of data queries and data entry.
• Maintain regulatory binders, CRFs, and source documents.
• Monitor adverse events and report to PI, sponsor, and IRB.
• Support clinical trial activities as required.

Skills

Organizational skills

Data analysis

Attention to detail

Word processing

Prioritization

Communication skills

Education

Bachelor’s degree

HS Diploma + 4 years related experience

Tools

Microsoft Word

Job description

Job Profile Summary

This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. An entry level role that applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area.

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.
• 3. IATA Hazardous Good Shipping certification.
• 4. CITI Human Research Protection certification.

Duties and Responsibilities

• 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.

At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day. The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals. Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth—one of the many ways we invest in you so you can thrive both at work and outside of it. Pay Range: $47,924.24 - $59,894.75 based on full-time equivalent Tufts Medicine is a leading integrated health system bringing together the best of academic and community health care to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Healthcare, an expansive home care network and a large clinically integrated physician network, Tufts Medicine has more than 15,000 dedicated employees and caregivers. The health system came together in 2014 to leverage the experience of its member organizations and integrate their missions to together transform the ways that consumers engage with and experience their care.