Jobs · Legal · Tennessee

Regulatory Coordinator

U.S. Urology Partners · Nashville Metropolitan Area · 1 mo ago
LegalFull-time
We need to output HTML fragment with sections: About the role (maybe not needed because job title already shown? The instruction: "Do NOT repeat the job title as a heading (the page already shows it)". The "About The Role" is a section heading; we can keep it as

About the role

. Use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include sections only when posting has real specific content. Let's parse content. Job title: Clinical Research Regulatory Coordinator. We have "About The Role" paragraph: description. Then "What You’ll Be Doing" list of duties: bullet points. Then "What We Expect From You": list of qualifications/experience. Then "Physical Demands", "Work Environment", "Other Duties", "Travel", "What We Are Offer You" (typo: "What We Are Offer You") includes benefits description. Then "About US Urology Partners": company description. Then "Salary Range: Please note that the hourly range for this position will vary based on experience level, education and geographical location. $0.00 - $0.00 / hour". This is placeholder; we should not create Pay section because it's not specific (just $0.00 - $0.00). So we omit Pay. Schedule: not mentioned. Benefits: we have description of benefits: "Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more." That's specific enough to create Benefits section. We also have "Travel" section: "Travel includes out-of-the-area, and overnight travel is to be expected." That's specific enough for Travel? But Travel is not in allowed headings list; allowed headings are About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Travel is not listed, so we should not create a Travel heading. Instead we could fold travel info into Responsibilities or maybe under About the role? The instruction: "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It says e.g., implying those are examples but we should use those headings when appropriate. It doesn't forbid other headings, but says "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." Likely they expect only those headings. So we should map content to those headings. Thus sections: - About the role: intro paragraph. - Responsibilities: the "What You’ll Be Doing" list. - Requirements: maybe combine "What We Expect From You" (experience, skills, education) plus maybe "Physical Demands" and "Work Environment"? But those are not requirements; they are job details. Could put them under Requirements? Might be okay but better to have Qualifications and Skills separate. The list includes: 2-5 years of clinical research experience is desirable, Excellent verbal and written communication skills, High level of organization, Experience in project management, Proficiency in Microsoft Office (Word, Excel), Bachelor's degree in related field, Willing and able to travel to other sites to ensure compliance, Attention to detail, Ability to manage multiple responsibilities simultaneously, Reasoning Ability (various subpoints), Computer Skills, Physical Demands, Work Environment. We could split: Requirements: experience, education, core qualifications. Skills: communication, organization, project management, MS Office, attention to detail, multitasking, reasoning, computer skills. Qualifications maybe overlapping. But we have limited headings; we can use Requirements for experience/education, Skills for abilities, and maybe Qualifications for degree? But we can combine. Simplify: Use Requirements for experience and education; Skills for abilities (communication, organization, project management, MS Office, attention to detail, multitasking, reasoning, computer skills). Qualifications maybe not needed. But we also have Physical Demands and Work Environment; could be placed under Requirements? Might be okay but they are not requirements per se. Could create a separate section? Not in allowed list. Could fold into Responsibilities? Not appropriate. Could create a section "Working Conditions" but not allowed. Probably we should omit them as they are generic boilerplate? However they are specific details about physical demands and work environment; they are not boilerplate? They are somewhat standard but still specific. The instruction: "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." Physical demands and work environment are not those; they are part of job description. But we have no heading for them; we could incorporate them into a paragraph under About the role or Responsibilities? Might be okay to add a paragraph after Responsibilities about physical demands and work environment. However the instruction: "Prefer a few substantive sections over many thin ones." So we could have About the role, Responsibilities, Requirements, Skills, Benefits. That's five sections. We'll put Physical Demands and Work Environment as a paragraph under Responsibilities or maybe under About the role? Probably under Responsibilities as they relate to job performance. Travel info: also could be under Responsibilities. Now Benefits section: we have description. We must not include Pay section because it's placeholder. We must not include Schedule. Now we need to output HTML fragment only, no /, no markdown. We'll produce:

About the role

...

Responsibilities

  • ...
  • ...

Requirements

  • ...
  • ...

Skills

  • ...
  • ...

Benefits

  • ...
  • ...
Make sure to preserve all substantive information. Let's extract details. About the role paragraph: "We are seeking a Clinical Research Regulatory Coordinator (CRRC) who is enthusiastic about clinical research and thrives in a team environment. The Clinical Research Regulatory Coordinator will be responsible for maintaining clinical trial regulatory documents and ensuring all sites adhere to the ICH-GCP guidelines and site operating procedures. The CRRC will also assist with the maintenance of staff documentation and site-specific certifications. The successful applicant will be extremely organized, can communicate effectively with multiple clinical research staff, collaborate with external vendors, and enjoy working in a dynamic work environment." We'll keep that as

. Responsibilities list from "What You’ll Be Doing": - Organize and maintain study documents - Oversee staff and site related documentation and certifications - Ensure regulatory compliance by all sites to ICH-GCP guidelines and site operational procedures - Prepare site for regulatory inspection - Submit continuing review reports - Submit new study IRB submissions - Travel to U.S. Urology Sites to review Regulatory - Work with Operational Support Specialist during study start-up to provide all necessary documentation for site activation - Attend meetings as required - Performs other duties as assigned We'll keep each as

  • . Requirements: from "What We Expect From You" we need to extract experience, education, etc. List: - 2-5 years of clinical research experience is desirable - Excellent verbal and written communication skills (but that's skill) - High level of organization (skill) - Experience in project management (skill/experience) - Proficiency in Microsoft Office (Word, Excel) (skill) - Bachelor's degree in related field (education) - Willing and able to travel to other sites to ensure compliance (maybe requirement) - Attention to detail (skill) - Ability to manage multiple responsibilities simultaneously (skill) - Reasoning Ability (subpoints): - Ability to discern prioritization of tasks and actively manage ongoing responsibilities is crucial. - Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. - Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. - Computer Skills: To perform this job successfully, an individual should have thorough knowledge in computer information systems. - Physical Demands: ... (we may put elsewhere) - Work Environment: ... (maybe elsewhere) We need to decide what goes into Requirements vs Skills. Requirements could be: experience, education, willingness to travel, maybe physical demands? But physical demands is not a requirement but a condition. Let's put Requirements: experience, education, willingness to travel, maybe also "Bachelor's degree". Also maybe "2-5 years of clinical research experience is desirable". Also "Willing and able to travel to other sites to ensure compliance". Also maybe "Bachelor's degree in related field". Also maybe "Experience in project management" could be skill. Skills: communication, organization, project management, MS Office, attention to detail, multitasking, reasoning abilities (the three subpoints), computer skills (thorough knowledge in computer information systems). Also maybe "Ability to discern prioritization..." etc. We'll create Skills list with those items. Now Benefits: from "What We Are Offer You": "Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more." We'll put that as
    • ...
    maybe single li. We also have "About US Urology Partners" company description. Should we include? It's substantive info about employer. Could be placed under About the role? Or maybe a separate section "About the company" but not allowed heading. Could fold into About the role paragraph after the role description. The instruction: "Preserve ALL substantive information". So we need to include that description somewhere. We can add a paragraph after About the role or as a separate section maybe "About the company" but not in allowed headings. Could add a

    after About the role before Responsibilities. That seems okay. Thus About the role section will have two paragraphs: first about role, second about company. Now Physical Demands and Work Environment: we need to include them somewhere. Could add a paragraph under Responsibilities or maybe under Requirements? Probably under Responsibilities as they relate to job performance. We'll add a

    after the responsibilities list: "Physical Demands: ..." and "Work Environment: ..." as separate paragraphs. Now Travel: we already have travel to sites in responsibilities list; also "Travel includes out-of-the-area, and overnight travel is to be expected." Could add a sentence in responsibilities paragraph. We'll incorporate that as an extra

  • maybe: "Travel includes out-of-the-area and overnight travel as expected." But we already have a travel item: "Travel to U.S. Urology Sites to review Regulatory". We'll add another bullet for general travel expectation. Now ensure we don't include boilerplate like EEO etc. At the end there is EEO statement; we must remove. Also remove "Job is sedentary most of the time..." etc? That's Physical Demands; we keep. Now produce HTML. Check for any duplicated lines: we must not duplicate. Let's craft. About the role:

    We are seeking a Clinical Research Regulatory Coordinator (CRRC) who is enthusiastic about clinical research and thrives in a team environment. The Clinical Research Regulatory Coordinator will be responsible for maintaining clinical trial regulatory documents and ensuring all sites adhere to the ICH-GCP guidelines and site operating procedures. The CRRC will also assist with the maintenance of staff documentation and site-specific certifications. The successful applicant will be extremely organized, can communicate effectively with multiple clinical research staff, collaborate with external vendors, and enjoy working in a dynamic work environment.

    U.S. Urology Partners is one of the nation’s largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network

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