Senior Clinical Research Coordinator Job at Boston Children's Hospital (Brookline)

Senior Clinical Research Manager - Network Operations

The Senior Clinical Research Manager (CRM) provides strategic and operational ov...

Location

United States , Brookline; Brighton; Milford; Weymouth; Methuen; Foxborough; Londonderry

Salary:

105400.00 - 130500.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

Bachelor’s Degree required, with a minimum of 7+ years of related experience or Master Degree with 5+ years experience.
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
Experience in protocol development, data compilation and analysis.
Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
Expert knowledge of Federal and State regulations as they relate to research.
Strong interpersonal, organizational and communication skills are required.
Must have computer skills including the use of Microsoft Office and working knowledge of Livelink
EPIC and OnCore applications.
Has expert knowledge of and is fully proficient in ability to execute clinical trials start-up, active and close out phases.
Is fully proficient in their knowledge of clinical research local policy and federal regulation.

Job Responsibility

CLINICAL TRIAL OPERATIONS: Responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.
Oversee the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate.
Collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS) and the Quality Assurance for Clinical Trials (QACT) to fulfill local and federal requirements governing human clinical trials.
Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
Assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
Work collaboratively with clinical research administration and grant managers to help monitor and reconcile all study and related grant finances as needed.
Assists the principal investigator in preparing manuscripts for publication.
Collaborate with the DFCI CTO and DF/HCC QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
Oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.

Fulltime

Senior Clinical Research Coordinator

The Computational Health Informatics Program (CHIP) is seeking an experienced, h...

Location

United States , Boston

Salary:

58676.80 - 93901.60 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor’s degree
Master’s preferred
Bachelor’s degree and 4 years of relevant work experience OR Master’s degree and 2 years of relevant work experience
Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex
Well-developed communication skills to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions
Ability to effectively engage with and influence others
build working relationships and can work independently and as a team member, leads others when needed
Act as a resource and must be knowledgeable and compliant in all hospital, State, and Federal regulatory requirements, including hospital policy and procedures

Job Responsibility

In conjunction with the Principal Investigator and/or designees designs, develops, and implement clinical research projects such as enrollment strategies, study materials, and study documents
Responsible for daily operations of the study
Develops and implements processes and procedures to meet study goals and protocol requirements
Participate in training and prepare study related training materials
Plans and prioritizes the work of administrative and support personnel on all clinical study activities
Consents and enrolls patients for research studies by providing detailed information on the Clinical Study to patients and families
Communicates all policies and procedures and responds to all inquiries
Evaluate the suitability of prospective study candidates and make selections based on clinical knowledge of each study
Provide input for updates of SOPs and drafting of new quality documentation
Assist with developing and implementing best practice guidelines for conducting various clinical research protocols

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

Clinical Research Coordinator II-OB/GYN

Under minimal supervision, coordinates the clinical assessments of the study sub...

Location

United States , New York

Salary:

63653.84 - 85000.06 USD / Year

Mount Sinai Health System

Expiration Date

Until further notice

Requirements

Bachelors degree in sciences or related field
2 years of clinical research

Job Responsibility

Analyzes moderately complex clinical research data
Assists in interpreting clinical research data
Coordinates the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects
Prepares and ensures grant applications, IRB/GCO documents are submitted
Ensures accurate and complete compilation of subject data through chart reviews
Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
Obtains informed consent under supervision of the Principal Investigator, Clinical Research Manager, or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for studies involving genetic tests
Independently obtains informed consent for other clinical studies
Mentors Clinical Research Coordinators in training
Performs other related duties

Senior Clinical Research Specialist

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

60431.00 - 84603.00 USD / Year

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 3 years of relevant experience required
Ability to effectively manage complex research protocols/procedures required
Fully adheres to applicable safety and/or infection control standards
Proficiency in medical terminology, the clinical research process, and applicable regulatory guidelines, standards preferred
Proficiency in managing multiple and competing priorities/demands
Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, and OSHA guidelines throughout study implementation
Exceptional interpersonal, organizational, and time management skills
highly collaborative, promotes teamwork
Ability to build collaboration among research team members, laboratory staff, patients, and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients)
Proficient in MS Office (e.g., Word, Excel, and PowerPoint), email, and internet

Job Responsibility

Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols
Manages the day-to-day operations of multiple studies, carrying out study coordination duties from protocol development and initiation through to study close-out in accordance with regulatory/sponsor guidelines
Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures
Works closely with study team members and other study sites to ensure the safety and adherence of study participants to the study protocol
Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities and personnel
Coordinates enrollment of participants
Oversees and facilitates eligibility screening and study recruitment activities
Plans study timelines and schedules appointments and study visits
Manages and organizes case report forms, source documents, and research records
Enters research data into data collection forms and/or study databases

Fulltime

Senior Contract Specialist, Clinical Research Agreement

At Boston Children’s Hospital, the quality of our care – and our inclusive hospi...

Location

United States , Boston

Salary:

69888.00 - 111831.20 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor’s degree
2+ years of relevant experience
Identifies and resolves highly complex ethical, and/or operating problems
Ability to effectively negotiate with peer level department heads and/or with external agencies/facilities on issues and programs that impact department as well as several other large departments/divisions.

Job Responsibility

Drafts and negotiates written clinical research related agreements with corporate sponsors and other outside entities
Conducts negotiation of complex clinical research agreements and attends to relevant terms
Assures timely completion of negotiation proceedings
Acquires and maintains knowledge of Hospital’s policies and procedures applicable to clinical sponsored research and, applicable Harvard faculty policies and, other academic and professional standards for the conduct and administration of clinical sponsored research
Acquires understanding of corporate sponsor interests and of the regulatory environment and requirements for the research and development of products for market approval
Develops functional understanding of the business needs of the hospital administrative and research staff for the effective conduct and administration of clinical corporate sponsored research arrangements
Evaluates and makes recommendations for systems, policies and procedures to promote effective interaction between the hospital and industry for mutual benefit
Identifies, prioritizes and implements policy, programmatic and administrative procedural changes to enhance operational efficiency and effectiveness
Advises faculty on BCH and sponsor requirements for clinical corporate sponsored research agreements
Reviews all agreements and payment terms within budgets to ensure conformance with Hospital policies

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime