Role: Clinical Data Specialist

Company: Profound Research

Location: Remote

The Company

Profound 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 Exists

Prepare 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.