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Clinical Research Coordinator II

4 months 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 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.