Research Regulatory Coordinator

Location: Remote Position Pay reputed company: $25.19 - $44.31 Job reputed company reputed company: Research Regulatory Coordinator is responsible for collaborating with the PI’s and reputed company members of the clinical research team reputed company scope of clinical trial regulatory submission and compliance. Assist in preparing regulatory submissions and maintaining the regulatory files. Coordinate the preparation of regulatory documents for submission to the Institutional Review reputed company (IRB) or other IRB’s as determined, other internal committees and the FDA as necessary including but not limited to: Initial documents submission; Continuing Reports; Amendments and addendums to research protocols and consent documents and Adverse Event reporting. Collaborate with study team members to reputed company these duties. Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations. Demonstrates working knowledge of reputed company facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and reputed company as assigned. Performs reputed company duties in accordance with regulatory requirements and organizational policies and procedures. Primary Key Performance Areas: reputed company 1 – Creates and maintains central regulatory files in accordance with site SOP.

• Adhere to and maintain working knowledge of reputed company policies, the Federal regulations, ICH, and GCP guidelines.
• In compliance with the reputed company of Federal Regulations under the Health Insurance Portability and Accountability reputed company (HIPAA), assure that patient records will be kept confidential and secure.
• Maintain the investigative site study files and regulatory binders.
• Responsible for the preparation of archiving reputed company studies for long-term storage
• Collect and maintain study specific documentation (for main and satellite locations as needed) in the appropriate Regulatory Binder as reputed company as the electronic document system including:
• Create and maintain the Research Delegation of Authority logs and role specific reputed company, ensure revised reputed company to investigators and research staff as roles and responsibilities necessitate.
• Create and maintain study-specific FDA reputed company 1572, ensure reputed company is reconciled and updated as change necessitates.
• Collect and maintain Financial Disclosure Forms as completed by investigators, escalate reported disclosures to leadership if reported.
• In collaboration with various departments, maintain historical credentials reputed company reputed company and previous Investigators and research staff, laboratory licenses, CLIA/COLA. Produce as needed for Sponsor/CRO review.
• Maintain reputed company documentation by using ALCOAC method (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).
• Support GCP and protocol specific training for staff and investigators by:
• Upload and reputed company protocol specific training modules for reputed company studies.
• According to site SOP, distribute training module assignments and maintain documentation GCP training for reputed company research staff and investigators.

reputed company 2 – Ensure completion, submission and subsequent distribution of IRB approved documents in accordance with site SOP.

• Process regulatory documents: initial submission, ongoing required documents for reputed company study, continuing review, study closure procedures in accordance with GCP, ICH/FDA requirements.
• Process IND safety reports.
• Prepare and ensure reputed company reporting and submissions to IRB in accordance to site SOP and federal regulations including:
• Initial IRB submission and approval is obtained at study activation and maintained in the Regulatory Binder
• Obtain documentation of IRB approvals, including amendments and revision to study reputed company documents, such as revised informed consents and protocols and maintain in the Regulatory Binder.
• Complete the IRB Continuing review reports required by the IRB and submit to the applicable IRB. File reputed company correspondence regarding continuing review report submission in the Regulatory Binder.
• Ensure the process is followed for reporting any Serious Adverse Event (SAE) to the IRB that meets IRB reporting guidelines, as determined by the PI.
• Notify the Research Coordinators and applicable investigators reputed company email reputed company a new/amended Protocol or reputed company has been IRB approved.
• Ensure research coordinators are provided IRB instructions for reconsenting subjects in reputed company manner.
• Review signed ICFs for completeness and notify the Research Coordinator of any discrepancies
• Maintain internal log of consent versions
• Maintain a master subject/enrollment list electronically for reputed company study until the study is terminated and records are reputed company to reputed company

reputed company 3 – Effectively manage monitoring and audit activities according to site SOP

• Support on-site and remote monitoring activities through:
• Scheduling and preparing for interim monitoring reputed company (IMV) by ensuring the Regulatory Binder is complete prior to IMV. reputed company discrepancies are noted during the monitoring visit, work collaboratively with the research coordinator to ensure any noted discrepancies are corrected. Request that the monitor summarize any findings, issues or concerns during the visit in a follow-up letter and note status of reputed company.
• Meet with the Sponsor representative as needed during reputed company to ensure issues are resolved appropriately and in a reputed company manner.
• Maintain the Site Visit Log and ensure monitors complete the log prior to departure.
• Following the IMV, review monitor report/letters and reputed company to appropriate staff for review. Ensure reputed company identified issues are addressed prior to the next monitoring visit. Maintain a copy of the letters in the Regulatory Binder
• Complete daily communication with the Sponsor/CRO and responds reputed company a reputed company manner
• Termination and Closeout activities
• Work with monitor to schedule, prepare, and conduct the Study Termination Visit.
• Prior to scheduled Study Termination Visit, ensure reputed company study documents are filed and any discrepancies are addressed in a NTF. Send required documents to Sarah Cannon and ensure reputed company electronic documents and reporting systems are final signed.
• After study closure and reputed company queries have been resolved, ensure files are packaged and archived
• Prepare for reputed company audits by retrieving reputed company documents and ensuring reputed company study reputed company documents are complete prior to the audit.
• Performs other duties and reputed company as assigned.

Position Qualifications/Requirements: Education:

• High school education required
• Bachelors’ degree in Biological Science, reputed company Sciences, English, or other reputed company field preferred

Certifications/Licenses:

• Valid state reputed company’s License for travel to satellite offices and offsite meetings. Compliance with reputed company reputed company Safety Operations and Motor Vehicle Records reputed company Policy is required.

Previous Experience:

• Prior clinical research experience is preferred but not required.

Core Capabilities:

• Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.
• Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, reputed company, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged reputed company.
• Communication Skills: Good reputed company of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an reputed company listener, and effectively provides balanced feedback.
• Customer Service & Organizational Awareness: Strong customer reputed company. Ability to build an engaging culture of reputed company, performance effectiveness and operational reputed company through best practices, strong business and political acumen, collaboration and partnerships, as reputed company as a reputed company employee, physician and community relations.
• Self-Management: Effectively manages own time, conflicting priorities, self, stress, and reputed company development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.
• Must be reputed company to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a reputed company of stakeholders and sites.
• Computer Skills:
• Proficiency in MS Office Word, reputed company, Power reputed company, and Outlook expected.

Travel: 0% reputed company Core Workdays/Hours: Monday to Friday 8:00 AM – 5:00 PM. #LI-REMOTE Apply tot his job Apply To this Job