Profound Research:

Profound Research seeks to drive clinical innovation by partnering with community physicians to offer clinical research as a therapeutic option to their patients. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to grow its energetic team inspired by changing how patients and providers engage in clinical research.  

Our Mission: Improving Lives by Providing Advanced Therapeutic Options

Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research

Our Values:

Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions.

Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. 

Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. 

Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards. 

Profound Ethos

o Physicians are the Vanguard  

o All Decisions Improve Patient Care  

o Never Compromise Quality  

Role: Regulatory Specialist

Company: Profound Research

Department: Regulatory

Location: Remote, U.S.

Responsibilities

Support and maintain eRegulatory System

- Assist with the completion of study start-up documents (i.e. 1572, Financial Disclosure Form, IRB submission, site information sheet and other documents as needed)

- Upload and file correspondence as part of regulatory for each study.

- Maintain and update regulatory documents throughout the duration of study until study close- out.

- Follow standard operating procedures (SOPs)as assigned and per training matrix.

- Maintain current knowledge of regulatory affairs and/or issues.

- Report, monitor, distribute and maintain files for all safety information including investigational drug brochures, investigational new drug (IND) safety reports and serious adverse event (SAE) reports.

- Posts regulatory documents including protocols, amendments, consent forms, SAEforms, etc.

- Monitor daily IRB portals for all site study binders to ensure clinical research coordinators are aware of the release of IRB approved documents such as Protocol, Informed Consents, Investigator Brochures, etc.

- Review all monitor confirmation letters and follow-up letters and assist lead clinical research coordinator in submitting timely responses.

- Conduct periodic reviews of eRegulatory study binders to ensure that all binders are audit ready with required documents easily accessible and organized.

Support eRegulatory Training

- Review and ensure training completion on essential study documents according to Profound training guidelines.

Support Essential Document Communication

· Ensure all IRB approved documents are uploaded and distributed to Lead Coordinator and site staff such as Protocol Amendment, Informed Consent, and Subject Material, etc.

· Maintain staff CVs and current credentials.

· Reconcile monitoring letters and visits verifying receipt of monitor confirmation and follow-up letters

· Assist with the preparation of monitoring visits and ensure study documents have been uploaded and filed in eRegulatory platform.

· Tracks expirations and retrieves current documentation for medical licensures, CVs, and laboratory accreditations.

Support Trial Conduct

· Follow procedures pertaining to each study as applicable to department.

· Maintain regulatory calendar in Outlook for all site monitor/audit visits.

· Work closely with Clinical Research Coordinator, Regulatory Department and QA department to ensure QA audit report issues are resolved.

· Assist with audit and oversight visit preparation

· Attend Site Initiation Visit as needed, review study start-up documents and study logs collected at the time of visit, monitor visit and close out visit to facilitate with the use of eRegulatory system and help resolve any issues at the time of the visit.

· Perform other related duties including study enrollment, subject visits, etc. as delegated by clinical operations leadership or Sr. Director of Regulatory.

Requirements

· Experience in /with clinical research strongly encouraged.

· Experience with eRegulatory systems

· Proficient with Microsoft Word, Excel.

· Training in GCPis required.

· Strong focus on teamwork, attention to detail, excellent organizational and planning skills. Must be able to prioritize, excellent written and verbal communication skills, and work in a fast-moving environment.

· Ability to respond appropriately to sponsor/CRO representative.

· Maintain confidential information.

· Ability to project a professional, friendly, and helpful demeanor.

· Must be able to remain in a stationary position 90 % of the time.

· Constantly operates a computer and other office productivity machinery, such as a copy machine, fax machine, printer.

· Regular and punctual attendance.

· Perform other duties not specifically listed in this job description as assigned by the primary and secondary supervisors.

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.

Regulatory Specialist (Remote, U.S.)

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