Clinical Research Coordinator

If you are an existing employee of South Shore Health then please apply through the internal career site.

Requisition Number:

R-18681

Facility:

LOC0001 - 55 Fogg Road55 Fogg Road Weymouth, MA 02190

Department Name:

SSH Clinical Research Program

Status:

Full time

Budgeted Hours:

40

Shift:

Day (United States of America)

The Clinical Research Coordinator (CRC) is responsible for coordinating ongoing clinical research projects within South Shore Health (SSH). The CRC will be responsible for identifying and recruiting patients eligible for participating in the trials, obtaining informed consent, collecting and entering data, maintaining patient study files in accordance with legal and institutional guidelines, entering data into sponsor-specific electronic data capture forms, reconciling research billing, and, performing administrative tasks for research studies. The CRC will serve as the primary contact with patients enrolled in clinical trials at SSH, will liaise with trial sponsors, support studies from start up to closure, and will be responsible for complying with Institutional Review Board (IRB) requirements. The CRC will also support internal and external monitoring needs and quality improvement projects. This role requires Demonstrated success managing IRB submissions in a clinical research settings overseeing internal and external monitoring and quality assurance efforts, Demonstrated success in extracting and managing clinical data, and managing relationships with multiple internal and external partners. This role offers competitive salary, small and collaborative team, the ability to work autonomously once mastery of all elements of the role have been achieved, easy and convenient commute, and free parking. **Please include Cover Letter and Resume with application***
This role requires onsite presence in Weymouth, MA. Relocation is not provided. Sponsorship is not available for this role.

ESSENTIAL FUNCTIONS

1. ADMINISTRATION
a. Ability to interpret and adhere to detailed research protocols while maintaining compliance with SSH policies and procedures, local, state and federal regulations. Maintains close attention to detail and ability to prepare materials needed for study start up (e.g., standard operating procedures specific to protocols; development of protocol specific databases).
b. Prepares and maintains regulatory binders and ensures study compliance with all state, federal, IRB and South Shore Hospital requirements.
c. Screens patients for protocol eligibility, obtains informed consent, and registers study participants.
d. Extracts patient data from medical records, and enters study data in case report form, checks and transmits data to the study sponsor.
e. Coordinates recording and storage of data.
f. Monitors and documents all needed data in source documents. Prepares materials needed for sponsor initiated audits.
g. Interprets protocols and related requirements to physicians, nursing, and laboratory staff.

2. STUDY PREPARATIONS
a. Reads and understands protocols.
b. Attends trial training sessions (trial sponsored investigator meetings).
c. Hosts site visit and audits: prepares resources, facilitates meetings/audits, and ensures that documents are available to sponsor as required.

d. Prepares and files IRB submissions.

3. PATIENT CONTACT
a. Explains study to patient including testing and/or treatment involved, possible risks and benefits and answer questions.
b. Introduces study to eligible participants, explains the purpose, procedures, risks, benefits and voluntary nature of study participation. Gives participants the opportunity to read the consent form and to ask questions. Documents the consent process in the research record. Obtains informed consent from study participant as appropriate.
c. Develops a system to recruit study subjects through advertising, chart review, physician notification.
d. Follows patients who have completed or discontinued study: records data, interviews patients, schedules testing as needed.
e. Develops and/or uses existing screening forms to determine patient eligibility for specific studies. Determines patient eligibility for study participation using inclusion/exclusion criteria.
f. Develops patient testing/treatment schedules based on specific protocol requirements.
g. Obtains and records study data as specified in the protocol.
h. Provides telephone follow up and data collection as prescribed by the study protocols

4. INTERDEPARTMENTAL FUNCTIONS
a. Creates an atmosphere of cooperation among Investigator, nursing and research staff in order to complete common research goals.
b. Places research remind