Job Description
Job Description: Role Summary:
The Clinical Research Associate (CRA) in Biomeasures, Endpoints and Study Technologies plays a key role in assisting the operationalization and execution of internal clinical studies that will be run at the *** Innovation Research (PfIRe) Laboratory in ***'s Kendall Square facility (Cambridge, MA). This individual will work collectively with research, technical, and clinical leads as well as key stakeholders to operationalize and conduct studies. A successful candidate must be experienced in communicating effectively with both potential and enrolled research participants during conduct of a clinical trial including but not limited to: recruitment, screening, informed consent procedures, study conduct, and follow-up.
Digital Medicine is an industry-leading mobile/digital technology initiative striving to utilize digital continuous remote monitoring of patients' symptoms as Client endpoints for disease diagnosis, physical function measurements, and health state assessment. The PfIRe lab is a clinical research unit outfitted with state-of-the-art technology where studies may be conducted utilizing wearable sensors, environmental monitors, and other Client technologies.
The CRA, in close partnership with the Clinical Trial Manager has responsibility to assist and support for all study management aspects of assigned PfIRe Lab studies or may manage a unique part of studies (e.g. recruitment, scheduling, and ISF filing). This individual provides operational support to teams from study startup to study execution and involves face to face interactions with giving participants instructions for protocol related tasks during the study.
ROLE RESPONSIBILITIES
•Be a working member on a study
•Assist working with *** clinical checklists and Standard Operating Procedures (SOPs) to ensure compliance with good clinical practice, regulatory agencies, Institutional Review Boards (IRBs), and *** processes.
•Working with local SOPs pertinent to the specific site conduct of the PfIRe Lab.
•Assist CTM with *** compliance systems and registries (e.g. GDMS, pTMF, Clinical Trial Registries, monitoring visits, etc.).
•Assist in managing and updating all site-related documentation (protocols, consent documents, recruitment materials, training documentation, and notes-to-file).
•Provide support for Clinicians in the planning and management of key internal and external meetings.
•Partners with Biomeasures, Endpoints, and Study Technologies (BEST) colleagues on internal study execution. These responsibilities may include but may not be limited to activities including:
•Communication with interested and potential study participants both in the recruitment and screening phases of Digital Medicine trials.
•Conducting study procedures in the lab including instructing participants in study tasks.
•Coordinates with the CRA to maintain an accurate calendar of study schedules to ensure adequate staffing of studies and keeping track of participants.
•Developing eCRFs and working with vendor(s) on electronic data capture systems.
•Subject compensation and communications during the study and post-study.
•Interface with other functions including clinical, informatics, operations, and statistics.
•Working with the technical lead on collecting clinical study data using mobile/sensor-based technologies of interest to the research team
•Contribute to writing manual of study operations
•Works under general supervision and performs assignments using established procedures
BASIC QUALIFICATIONS:
•Bachelor's degree in science or related discipline. Prior experience as a study coordinator or direct involvement in clinical trial conduct.
•Working knowledge of GCP and ICH guidelines.
•Good working knowledge of application of digital and device technologies as well as information platforms is a plus
•Excellent written and verbal communication and interpersonal skills.
•Able to handle a moderate volume of highly complex tasks within a given timeline.
•Strong organizational skills and ability to prioritize work.
•Proficiency in MS Office: Word, Excel, PowerPoint, Project, etc.
•3 years of relevant experience.
Hard Skills:
1. Recruitment/People Skills (recruitment, screening, informed consent procedures, study conduct, and follow-up.)
2. Prior Clinical Research exp. (min 3yrs)
3. Team Player
4. Communication (Written/Verbal)
Soft Skills:
1. Phlebotomy
Position Comments visible to Supplier: **Phlebotomy is preferred
**Patient Facing - No specific insurance required
Initial duration is 18-months with potential to extend based on business needs.
Job Tags
Local area, Remote job,