Clinical Research Coordinator II - Zakim Center

Dana-Farber Cancer Institute; Boston (MA); On-site; USD 56,000 - 63,700; Full time

Job summary

Dana-Farber Cancer Institute in Boston is recruiting a Clinical Research Coordinator II (CRC II) to support oncology trials within the Zakim Center for Integrative Therapies and Healthy Living. The role includes primary data collection and management of patient information, timely trial assessments, potential sample collection, and preparation of study documentation under GCP.

The main site is the Longwood campus, with weekly travel to network sites.

Qualifications

• Bachelor's degree required or 2 years of CRC experience.
• 1-3 years of relevant experience preferred, with medical/scientific research background desirable.

Responsibilities

• Oversight of trial start-up from protocol receipt to site activation.
• Data reporting and data management including source documents and CRFs.
• Regulatory reporting and IRB submissions; maintain study and regulatory binders.
• Ensure proper collection, preparation, and shipment of protocol-related samples as applicable.
• Coordinate with multiple departments (Scheduling, Materials, Lab, Pharmacy, Nursing) per trial needs.
• Prepare for internal and external audits and study monitoring visits.
• Coordinate and manage trials through the life cycle; communicate with sponsors and regulators.
• Close-out trials and contribute to publications and regulatory communications.
• Interact with study participants as required by protocol and team.
• May collect tissue samples per trial requirements.

Skills

Organization skills

Communication skills

Interpersonal skills

Attention to detail

Time management

Discretion

Microsoft Office

Exercise science interest

Education

Bachelor's degree

Tools

OnCore

Job description

The Zakim Center for Integrative Therapies and Healthy Living is recruiting a Clinical Research Coordinator II (CRC II).

The CRC II is a critical member of the research team who will work on research projects focused on exercise and nutrition interventions to support oncology patients and survivors. The CRC II will 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 Associate Director of Research Operations.

The CRC II 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, including administering exercise and physical function testing. CRC II may also be responsible for the collection of protocol related samples including shipment to outside entities as applicable. 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.

The main location of this role is the DFCI Longwood campus, however travel to DFCI network sites (1x/week) 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 physicians/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Responsibilities

• 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

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
• Ability to effectively manage time and prioritize workload
• Must practice discretion and always adhere to hospital confidentiality guidelines
• Must have computer skills including the use of Microsoft Office
• Preferred experience in or interest in exercise science and/or the field of exercise oncology

Minimum Job Qualifications

• The position requires a bachelor's degree or 2 years of experience as a Dana-Farber Clinical Research Coordinator.
• Candidates should have 1-3 years of relevant experience, with a preference for those with a background in medical or scientific research or a technology-oriented business environment.

Supervisory Responsibilities

Orients and assists in training new staff.

Patient Contact

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. Will be responsible for data collection, including administration of exercise and physical function assessments.

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).

$56,000.00 - $63,700.00