Clinical Research Associate II

Davita Inc.; Newton (MA); Remote; USD 60,000 - 85,000; Full time

Job summary

A leading healthcare organization is seeking a motivated Clinical Research Associate II to support clinical trials within the Cancer Center. The CRA II will manage patient enrollment, data collection, and compliance with regulatory standards while working independently in a remote setting.

Qualifications

• 1-2 years of related experience required.
• Ability to work independently and as a team member.
• Working knowledge of clinical research protocols.

Responsibilities

• Enroll eligible patients for clinical research protocols.
• Maintain electronic research files and manage data collection.
• Monitor and report adverse events and deviations.

Skills

Analytical skills

Attention to detail

Organizational skills

Communication skills

Computer literacy

Problem-solving

Education

BA/BS degree

Job description

GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate II. The Cancer Center Protocol Office is a centralized research office that supports clinical researchers in all disciplines within the Cancer Center. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.
The Clinical Research Associate II (CRA II) works independently under general supervision to enroll eligible patients to clinical research protocols, maintain electronic research files for all enrolled patients and manage data collection for multiple cancer studies. The CRA II will be the liaison between the clinical team and the clinical trials sponsor(s), reaching out for clarifications, if needed, to ensure compliance with protocol requirements and will facilitate and manage study monitoring expectations in collaboration with the team's regulatory coordinator. Effective management of communications is key to this role. The CRA II will have experience with institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The CRA II will perform the following data management and other duties independently under general supervision by the Clinical Research Manager:
*Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
*Enroll patients as required by the study sponsor and internal enrollment monitor team
*Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
*Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
*Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
*Maintain electronic research files for all enrolled patients
*Ensure adequate source documentation is in place for all data reported
*Resolve data queries issued by the sponsor
*Obtain protocol clarifications from the study sponsor and communicate information to the research team
*Schedule and prepare for monitoring visits with sponsors
*Facilitate the request and shipment of archival pathology samples
*Organize and prepare for internal and external audits
*Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
*Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
*Maintain source documentation of correspondence with investigators and sponsors throughout the clinical trial process
*Participate in monitoring visits and file all monitoring visit correspondence
*Ensure appropriate documentation of delegation and training for all study staff members
*Maintain screening and enrollment logs
Tasks assigned to this role will be updated and/or changed as required to support the clinical research team

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Ability to work independently and as a team member
• Analytical skills and ability to resolve problems
• Adaptable and willing to take on new tasks as needed, to support the research team
• Ability to interpret acceptability of data results
• Careful attention to detail
• Good organizational and communication skills
• High degree of computer literacy
• Working knowledge of clinical research protocols
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS

• None

EDUCATION:

• BA/BS degree required

EXPERIENCE:

• Minimum of 1-2 years of related experience required.

SUPERVISORY RESPONSIBILITY:

• None

FISCAL RESPONSIBILITY :

• None

WORKING CONDITIONS:

Duties will be performed in the remote work setting

The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.