Clinical Research Coordinator - Cantor Center

Dana-Farber Cancer Institute; Brookline (MA); On-site; USD 48,000 - 54,000; Full time

Job summary

Dana-Farber Cancer Institute is seeking a Clinical Research Coordinator to support clinical trials under GCP guidelines. You will collect and manage patient data, maintain regulatory binders, and ensure protocol compliance with IRB submissions and site activations.

Responsibilities include source document handling, CRF development, adverse events reporting, and coordinating with multiple departments to keep trials on track. Some travel may be required.

Qualifications

• Excellent organization and communications skills required.
• Strong interpersonal skills – ability to effectively interact with all levels of staff and externals contacts.
• Must be detail oriented and have the ability to follow-through.
• Ability to effectively manage time and prioritize workload.
• Must practice discretion and adhere to hospital confidentiality guidelines at all times.
• Must have computer skills including the use of Microsoft Office.

Responsibilities

• Oversee clinical trials start-up from protocol receipt through IRB submissions and site activation.
• Manage data reporting, source documents, CRFs, AE reporting, filing and archiving of study records.
• Prepare regulatory reports and IRB submissions; maintain study binders and enter data into systems.
• Ensure collection, preparation, and shipment of samples per protocol and regulations.
• Collaborate with protocols, materials management, lab, pharmacy, nursing, and other departments as needed.
• Coordinate internal and external audits and monitoring visits.
• Manage trial life cycle communications with sponsors and regulators.
• Support close-out activities, contribute to publications, and liaise with regulatory agencies.
• Interact with study participants as required by protocol/team.
• May collect tissue samples per trial requirements.

Skills

Organization

Communication

Interpersonal skills

Time management

Discretion

Microsoft Office

Education

Bachelor’s Degree

Job description

The CRC (Clinical Research Coordinators) work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. Will support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements. May be responsible for pertinent IRB protocol submissions. This individual may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the clinical trials management system, ONCORE. Some travel may be required.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

• Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.

• Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries.

• May prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable.

• Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations.

• Collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments, as needed per the requirements of the clinical trial.

• Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.

• Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities.

• Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.

• Interact with study participants as directed/required by the protocol and/or study team.

• May be responsible for tissue sample collection per trial requirements.

• Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.

• Responsible for data entry of time and effort spent on study-specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed.

• Responsible for data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Excellent organization and communications skills required.

• Strong interpersonal skills – ability to effectively interact with all levels of staff and externals contacts.

• Must be detail oriented and have the ability to follow-through.

• Ability to effectively manage time and prioritize workload.

• Must practice discretion and adhere to hospital confidentiality guidelines at all times.

• Must have computer skills including the use of Microsoft Office.

MINIMUM JOB QUALIFICATIONS:

• Bachelor’s Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience required.

• 0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.

SUPERVISORY RESPONSIBILITIES: None

PATIENT CONTACT:

All positions: May have contact with Adult and Pediatric patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

EEO Poster

Pay Transparency Statement

The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).

$48,100.00 - $54,400.00