Clinical Research Coordinator

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 trials and projects related to ASD.

The CRC I will work under the supervision of the Clinical Research Program Manager and will participate in tasks related to all phases of the clinical research including the initiation, monitoring, completion, and reporting phases. All activities will be conducted in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP) Guidelines.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The incumbent will work as part of a multidisciplinary team and will be responsible for a range of activities including but not limited to:

• Collects, organizes, and enters participant data into approved program (e.g. REDCap).

• Crosschecks accuracy of participant data; may require double-data entry as required by protocols and GCP.

• Maintains records and databases (REDCap and other sponsor systems).

• Performs study tasks such as processing and shipping of research samples, monitoring temperature logs, and updating research calendar adhering to GCP and sponsor requirements.

• Assists primary coordinator of each study with recruiting patients for clinical trials, primarily through written outreach, EPIC appointment and encounter review, and assigned tasks related to marketing.

• Documents and reviews participant study visits and procedures for consistency and accuracy with protocol.

• Schedules participant study visits according to the protocol schedule of events and communicates changes with study team.

• Scores questionnaires.

• Performs phlebotomy and other laboratory procedures.

• Organizes regulatory binders by developing visit worksheets based on Schedule of Events, printing, filing, and reviewing binders to confirm all data has been filed.

• Performs tasks related to stipend processing

• Documents of task completion according to the protocol Schedule of Events.

• Conducts library searches as requested.

• Performs administrative support duties as required.

The individual will be working on-site at the Lurie Center, an outpatient clinic based in Lexington. Workspace includes a normal office environment, prolonged sitting and computer use. Exposure to bodily fluids, cleaning chemicals and other clinical research related hazards. Work hours are Monday - Friday with occasional need for alternate or additional hours to meet the needs to the clinical trials.

EDUCATION:

• Bachelor's degree required.

EXPERIENCE:

• New graduates with some relevant course/project work or those without any prior research experience will be considered; prior research experience preferred.

SKILLS:

• Careful attention to details

• Good organizational skills

• Ability to follow directions

• Good communication skills

• Computer literacy; Must be proficient with Microsoft computers and other databases and able to troubleshoot and problem solve independently

• Working knowledge of clinical research protocols

• Ability to demonstrate respect and professionalism for subjects' rights and individual needs

• High degree of professionalism

• Strong interpersonal skills, comfort working with people, and sensitivity towards a neurodiverse population.

• High degree of motivation and self-sufficiency

• Ability to complete and apply training, including clinical skills such as ordering and organizing lab materials and phlebotomy processing under supervision of a nurse or study supervisor.

• Ability to follow instructions and work under supervision.