Clinical Data Specialist (Remote, Eastern U.S.)

Role: Clinical Data SpecialistCompany: Profound ResearchLocation: Remote
The CompanyProfound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and your patients get access to the newest therapies available while you open up a new ancillary for your practice.
Mission, Vision, Values• Mission: Ensure that every patient has access to innovative treatments and improve patient lives.• Vision: The future of medical innovation rests in the hands of physicians and their everyday care delivery decisions.• Values:o Compassion: Honor the patient-physician relationship above all else.o Efficiency: Orient for outcomes and strive for process perfection.o Progress: Contribute to continued innovation in medicine while improving health outcomes.o Integrity: Hold ourselves to the highest ethical, quality, and scientific standards in every activity.
Profound Ethos• Physicians are the Vanguard• All Decisions Improve Patient Care• Never Compromise Quality
Why this Role ExistsPrepare and maintain complete and accurate source material to support the set up and delivery of clinical research studies.
Responsibilities- 1-2 years CRIO experience building source. · Ensures source documents are set up in a timely manner to ensure on-time study start up.· Follows a structured multi-step procedure to guarantee data source integrity.· Work under the guidance of senior team members, demonstrating a willingness to learn and adapt.· Reviews and comprehends the protocol and essential study documents, supporting material or guidelines.· Supports sites to ensure harmonization in source.· Demonstrates flexibility by working with multiple systems.· Manage source data in various formats, showcasing adaptability and proficiency.· Attend Site Initiation Visits (SIVs) to ensure a comprehensive understanding of study requirements.· Actively participate in sponsor-provided training and meetings to stay informed and updated on relevant protocols and procedures.· Communicate effectively regarding amendments and changes to source documents.· Maintain internal communication with the source team regarding source status and updates.· Adheres to safety and compliance regulations relevant to clinical data management.· Perform other duties as assigned.
Requirements· Bachelor’s degree in health-related field and/or successful completion of formal clinical training program (i.e., EMT, RN, MA) OR· Associate degree with relevant experience in the life science industry· Clinical research experience in lieu of degree
Preferred Experience· 3+ research experience· Customer facing experience
Travel Requirements· Occasional travel may be required in this position. (Less than 2 weeks per year)Physical Requirements· Prolonged periods of sitting at a desk and working on a computer, standing, and walking.· Must be able to lift 25 pounds at times.· Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.· Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.· Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.· The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.