Clinical Research Coordinator

Job Description Summary

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 significant coordination with multiple departments at South Shore Health including registration, laboratory, finance, pharmacy, radiology and pathology. The CRC will report to the Office of Research and is expected to lead on several research studies and to ensure that studies are successful.

Job Description

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 reminders in patient record prior to treatment/testing.
c. Devises/enters standard orders based on protocol requirements.
d. Works closely with multiple clinical departments to ensure study requirements are met.
e. Works with Patient Access Services and Patient Accounts to ensure payment tracking and compliance.
f. Works with Finance to reconcile billing needs

g. Works with various departments across the hospital to ensure study related information is communicated to appropriate individuals and that study activities are completed.

5. PROTOCOL MANAGEMENT FUNCTIONS
a. Reports all problems per protocol and documents with necessary parties; follow-up as required.
b. Understands and implements any protocol amendments along with updated Informed Consent forms.
c. If required, re-consents patients according to protocol updates.

6. STUDY DATA MANAGEMENT FUNCTIONS
a. Meets with Study Monitors; responds to data queries. .
b. Provides source documents, regulatory binders and Case Report Forms during study monitoring meeting/audits.

c. Routinely enters data required per protocol from patient source documents to Case Report Forms

d. Navigates patient charts to EPIC to obtain protocol specific data to reconcile billing.

7. REGULATORY FUNCTIONS
a. Works closely with the IRB; maintains compliance with regulatory policies.

b. Addresses any queries the IRB communicates to the investigator.

8. ORGANIZATIONAL/CLERICAL FUNCTIONS
a. Maintains all protocol books to contain updated study documents.
b. Organizes all contract documents, filing accurately; ensures excellent attention to detail.
c. Notifies Investigator(s) of any protocol changes, corrections or updates.
d. Organizes and prepares spreadsheets and other documents as requested. Maintains and organizes files (Word documents, e-mails, etc.)
e. Creates and maintains study patient enrollment grids (patient data, treatment/testing/follow up dates, etc.).

Technology and Learning
a. Participates in continued learning and possess a willingness and ability to learn and utilize new technology and procedures that continue to develop in their role and throughout the organization.
b. Embraces technological advances that allow us to communicate information effectively and efficiently based on role.

JOB REQUIREMENTS

Minimum Education

Candidates with a Bachelor’s degree in a scientific, health related, or business administration program, preferred. At minimum, a candidate must have a Bachelor’s degree. 

Minimum Work Experience

Minimum 2-3 years in a clinical research environment preferred.

Required additional Knowledge, and Abilities

• Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire
• Must be proficient in filing submissions with the IRB within six months of hire
• Must be proficient in research billing and reconciliation in EPIC within six months of hire.
• Knowledge of oncology research, and good clinical practice Medical terminology and medical records training; strong attention to detail and organizational skills
• Has a friendly demeanor and is a strong team player. Once fully trained, requires minimal supervision and is a self-starter.