CLINICAL RESEARCH COORDINATOR II

2 weeks ago

Lexington MA USA, United States Massachusetts General Hospital Full time
GENERAL SUMMARY/ OVERVIEW STATEMENT:

Williams syndrome (WS) is a rare genetic disorder which is associated with a broad array of medical, developmental, and behavioral/emotional issues. The Williams Syndrome Program, a cooperative program between the Lurie Center and Massachusetts General Hospital, provides clinical care across the lifespan to individuals with WS and also conducts research. The Williams Syndrome Program is seeking a Research Coordinator II to implement a portfolio of WS clinical research projects.

The Clinical Research Coordinator II (CRC II) will work under the supervision of the Program co-directors, Drs Robyn Thom and Barbara Pober. The CRC II will participate in tasks related to numerous phases of clinical research including recruitment, consenting, data collection, monitoring, completion, and reporting. Maintaining regulatory compliance is an important aspect of the position. All activities will be conducted in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP) Guidelines.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Specific tasks include but are not limited to:

Recruitment:

* Participate in the development and implementation of patient recruitment strategies.
* Coordinate recruitment activities including frequent interaction with potential subjects, communication with internal and outside clinicians, written outreach, EPIC appointment and encounter review, presenting to small groups, creating social media content, and other tasks designed to market studies.
* Provide basic explanation of the research study.
* In conjunction with the PI, verify subject inclusion/exclusion criteria and confirms subject meets criteria.

Data Management:

* Score patient questionnaires and enter data in required database.
* Collect, organize, and enter participant data into approved program (e.g. REDCap); perform QA/QC checks
* Collects patient study data from medical records as needed.
* Crosscheck accuracy of participant data may require double-data entry as required by protocols and GCP.
* Perform data analysis and interpret data.
* Maintain research data, regulatory binders and study databases (REDCap and other sponsor systems).
* Perform tasks related to stipend and sponsor invoice processing

Participant/Visit Management:

* Act as a study resource for patient and family.
* Obtain informed consent from subjects/families.
* Perform study tasks such as processing and shipping of research samples, monitoring temperature logs, and updating research calendar adhering to GCP and sponsor requirements.
* Document and review participant study visits and procedures for consistency and accuracy with protocol.
* Schedule participant study visits according to the protocol schedule of events and communicate changes with study team.

Other Research Tasks:

* Conduct library searches as requested.
* Contribute to protocol development by writing drafts under PI guidance (e.g. develop schedule of events, consent language, background sections of protocol based on library searches). Prepare annual and other requested reports from the sponsors under PI direction.
* Prepare for monitor visits and/or remote reviews of data and site processes.
* Draft responses to sponsor's standard or special audits under the direction of the PI.
* Complete study reports, including documentation of adverse events, for sponsor and IRB as requested under PI direction.
* Conduct segments of training and orientation of new staff members.
* Perform other research and administrative support duties as required.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

* Knowledge of clinical trial process, procedures and regulations, including patient recruitment and visit management.
* Understanding of effective data collection with skills in data management and analysis and appropriate use of databases, such as RedCap.
* Understanding of and ability to comply with protocols and instructions along with the ability to effectively work with internal resources, including the IRB.
* Administrative skills to support own work and that of the Principal Investigator and others, including meeting management, presentations and data entry.
* Must be able to work for and with Principal Investigator and team as well as able to work independently.
* Able to work carefully, accurately, and consistently and follow directions.
* Work safely and follow applicable safety requirements.
* Excellent communications skills, including verbal and written communication and interpersonal skills.
* Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
* Reliably maintain accurate records.
* Identify and resolve technical and process issues.
* Possess the ability to prioritize tasks and meet deadlines.
* Analytical skills with an understanding of and skills in data analysis.
* Ability to interpret acceptability of data results.
* Working knowledge of data management programs.
* Use social media as a tool to promote communication about research studies
* Superior organizational skills with careful attention to details.
* Computer literacy including Microsoft applications.

EDUCATION:

* Bachelor's degree required in applicable scientific field of study.

EXPERIENCE:

Minimum of 1 year of directly related work experience in clinical science research required. Familiarity with MGB e-IRB portal (Insight), electronic medical record platform (Epic), and HIPAA compliant data capture platform (REDCap) preferred.

Some experience conducting research and/or interacting with individuals with neurodevelopmental disorders is desirable.

  • Clinical Research Coordinator II

    2 weeks ago

    Lexington, United States Massachusetts General Hospital Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: Williams syndrome (WS) is a rare genetic disorder which is associated with a broad array of medical, developmental, and behavioral/emotional issues. The Williams Syndrome Program, a cooperative program between the Lurie Center and Massachusetts General Hospital, provides clinical care across the lifespan to individuals...

  • Clinical Research Coordinator

    1 day ago

    Lexington, United States Massachusetts General Hospital(MGH) Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: The Lurie Center for Autism, a Mass General Brigham program based in Lexington, is a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder (ASD). The Center is seeking a Research Coordinator I to assist with implementing a portfolio of clinical research...

  • Clinical Research Coordinator

    2 days ago

    Lexington, Kentucky, United States Massachusetts General Hospital(MGH) Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: The Lurie Center for Autism, a Mass General Brigham program based in Lexington, is a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder (ASD). The Center is seeking a Research Coordinator I to assist with implementing a portfolio of clinical research...

  • Clinical Research Coordinator I

    4 days ago

    Lexington, United States Shriners Childrens Hospital Full time

    Company Overview Shriners Children's is a family that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our compassion,...

  • RESEARCH NURSE COORD II

    6 days ago

    Worcester, MA 01601, USA, United States University of Massachusetts Medical School Full time

    OverviewGENERAL SUMMARY OF POSITION:Under the direction of the Principal Investigator or designee, the Research Nurse Coordinator II is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Research Nurse Coordinator II is a primary resource for study protocol conduct...

  • CLINICAL RESEARCH NURSE

    1 week ago

    Wildwood, MO 63005, USA, United States Headlands Research Full time

    OverviewClinical Research Professionals (CRP) is a dedicated research center that provides a network of physicians who work collaboratively in conducting clinical research trials. Our team consists of experienced research professionals helping to improve lives through the advancement of new drug therapies and medical devices. We have recently partnered with...

  • Clinical Research Coordinator I

    7 days ago

    Lexington, Kentucky, United States Shriners Children's Full time

    Company Overview: Shriners Children’s is a family that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our...

  • Clinical Research Coordinator I

    1 day ago

    Lexington, Kentucky, United States Shriners Children's Full time

    Company Overview: Shriners Children’s is a family that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our...

  • Research Associate Clinical II

    4 days ago

    Lexington, United States The University of Kentucky Full time

    The Research Associate will be responsible for: Managing research projects; maintaining records; producing reports Recruiting subjects and obtaining consents for research studies / clinical trials. Obtaining and maintaining IRB approval for research Research Associate, Clinical, Research, Associate, Clinic, Healthcare, Education

  • CLINICAL RESEARCH NURSE II

    3 weeks ago

    Lebanon, NH 03766, USA, United States Dartmouth-Hitchcock Concord Full time

    OverviewClinical Research Nurse II performs a full range of clinical and non-clinical research duties, and has a working knowledge of the clinical research process and the regulations that govern it. As licensed professionals with clinical research experience, they perform patient related care independently, including medical assessments, symptom management,...

  • Research Nurse Coord II

    10 hours ago

    Worcester, MA, United States University of Massachusetts Medical School Full time

    Overview GENERAL SUMMARY OF POSITION: Under the direction of the Principal Investigator or designee, the Research Nurse Coordinator II is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Research Nurse Coordinator II is a primary resource for study protocol...

  • Research Associate Clinical I

    2 weeks ago

    Lexington, United States The University of Kentucky Full time

    Clinical trial recruitment coordinator position in a dynamic and well-funded aging and dementia clinical trials unit. This position offers an opportunity to work with diverse populations of older adults through outreach and recruitment for clinical a Research Associate, Clinical, Clinical Research, Associate, Research, Healthcare, Education, Clinic

  • Clinical Research Program Manager

    2 weeks ago

    Lexington, United States Shriners Childrens Hospital Full time

    Company Overview Shriners Children's is a family that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our compassion,...

  • STEPS Research Farm Tech II

    7 days ago

    Lexington, United States The University of Kentucky Full time

    The Martin-Gatton College of Agriculture Food and Environment seeks a Research Farm Technician II for the Research Farms division. The Research Farms provide a vast array of teaching, research and extension opportunities for the faculty, staff and st Research, Farm, Tech, Technician, Healthcare, Education, Maintenance

  • RESEARCH NURSE II, EQUITABLE BREAKTHROUGHS IN MEDICINE DEVELOPMENT

    6 days ago

    Houston, TX, USA, United States Texas Southern University Full time

    The Research Nurse II manages clinical research projects for Principal Investigators by gathering patient data via methods specified in the study protocol. Provides complex administrative duties in support of the study to ensure compliance with regul Clinical Research, Research, Clinical, Development, Medicine, Nurse, Healthcare

  • Research Coordinator

    2 weeks ago

    Lexington, United States The University of Kentucky Full time

    The position involves actively participating in research projects focused on social and behavioral interventions for cardiometabolic disorders within vulnerable populations. Responsibilities include traveling to local and rural communities to engage Research Coordinator, Research, Coordinator, Education, Business Services

  • CLINICAL RESEARCH NURSE II

    3 weeks ago

    William Penn Annex West, PA 19107, USA, United States Temple University Health System Full time

    Coordinate and facilitate the conduct of clinical research protocols which may be supported by NCI, industry, cooperative groups, or grant funded and investigator-initiated. Provide leadership in the management and operation of clinical research protocols to ensure research participant recruitment and accrual, protocol compliance, research participant safety...

  • CLINICAL RESEARCH NURSE II

    3 weeks ago

    William Penn Annex West, PA 19107, USA, United States Temple University Health System Full time

    Coordinate and facilitate the conduct of clinical research protocols which may be supported by NCI, industry, cooperative groups, or grant funded and investigator-initiated. Provide leadership in the management and operation of clinical research protocols to ensure research participant recruitment and accrual, protocol compliance, research participant safety...

  • Clinical Research Program Manager

    1 week ago

    Lexington, Kentucky, United States Shriners Children's Full time

    Company Overview: Shriners Children’s is a family that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our...

  • Clinical Research Program Manager

    1 day ago

    Lexington, Kentucky, United States Shriners Children's Full time

    Company Overview: Shriners Children’s is a family that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our...