Jobs · Analyst · North Carolina

Senior Clinical Research Coordinator

Innovo Research · Wilmington, NC · 1 mo ago
AnalystFull-time
We need to output HTML fragment with sections: About the role? The description includes JOB SUMMARY, Responsibilities, Qualifications, Benefits, Working Conditions. According to rules: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We should map headings appropriately. The posting has JOB SUMMARY (maybe About the role), Responsibilities, Qualifications, Benefits, Working Conditions (maybe not a standard heading but we could include as a section? The instruction: include a section ONLY when the posting has real, specific content for it. Working Conditions is present with details. Should we create a heading? The allowed headings list does not include Working Conditions, but we can still use

for any section heading? It says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It gives examples but not exclusive. Likely we should use those standard headings where applicable. For Working Conditions, maybe we can incorporate into About the role or omit? But we must preserve all substantive information. We could create a

Working Conditions

as it's a specific section. The instruction says use

for section headings (e.g. ...). It doesn't forbid other headings. So we can use

Working Conditions

. Also we should not repeat job title. No Job ID. Remove boilerplate like EEO etc. We'll strip the EEO paragraph and visa sponsorship etc. Also remove "More in-depth information can be found in SOP's..." etc. Also remove "The above statements are intended..." etc. Also remove "Innovo Research is committed..." etc. Also remove "Applicants must be authorized..." etc. Also remove "Due to the nature of this position..." maybe part of Working Conditions? Actually that is part of Working Conditions. We'll keep the substantive description of working conditions but remove the EEO statements. We need to use
  • for any list of duties/requirements/benefits. So for Responsibilities we need to convert the paragraph into list items. The responsibilities paragraph is long with many duties separated by semicolons and periods. We should split into logical list items. Similarly Qualifications: list items. Benefits: list items. Working Conditions: maybe a paragraph or list? It's prose describing conditions; we can keep as

    . But we could also list items for each condition. Safer to keep as

    . We must not invent or summarize away detail. Must preserve all substantive information. So we need to ensure we capture all duties, qualifications, benefits, working conditions details. Let's extract: Job Summary paragraph: "The Senior CRC will work closely with Principal Investigators and clinical research teams to coordinate the daily operations of clinical research studies and oversee clinical research staff performing clinical functions at the designated Innovo Research partner site The Senior CRC will be responsible for making sure that all clinical research activities are efficiently executed, and conducted in a professional manner that is compliant with all human research subject regulations. Experience in cardiology is preferred." We'll put that as

    under About the role (or Job Summary). Use heading

    About the role

    . Responsibilities: The block after "Responsibilities". Let's parse sentences: - Assist with mentoring and training clinical research staff. - Perform clinical functions i.e. phlebotomy, monitoring vital signs on study participants, etc., when warranted; educate family and contribute to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria. - Liaises with agencies, pharmaceutical companies, laboratories, vendors, equipment, and supply companies as needed; oversees availability of supplies and/or equipment for studies. - Manage multiple concurrent trials - screening, recruiting, and enrollment, perform patient/research participant scheduling, coordinate protocol-related research procedures, study visits, and follow—up, collect patient/ research participant history, collect and maintain source documentation, perform data entry and query resolution, prepare IRB submissions, update required modifications, continuing reviews, and reportable events. - Develop strong working relationships and maintain effective communication with study team members. - Completes all protocol-related training and adheres to IRB approved protocol(s) - Support the collection and review of required essential study documents and reports. - Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging, and laboratory handling manuals, etc.). - Assist in the informed consent process of research subjects. - Support and advocate for the safety of research subjects. - Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities. - Collect, process, and ship laboratory specimens. - Comply with Innovo, Clinic, and Sponsor policies, standard operating procedures (SOPs), applicable regulatory requirements and guidelines. - Performs all additional duties as assigned. We'll make each bullet a
  • . Qualifications: The block after "Qualifications". It repeats "Qualifications" heading then content. Let's extract: - At least 3-5 years of experience coordinating clinical trials, including the activities listed above. - Cardiology experience is preferred. - BS/BA in Life Science or related discipline. - Certified Clinical Research Coordinator (CCRC) certification preferred. - Previous GCP training and certification required and working knowledge of current ICH GCP guidelines and applicable regulations. - Experience in a clinical setting. - Demonstrated ability in positive relationship building. - Previous experience with training and mentoring other clinical research professionals is a plus. - Strong interpersonal skills with attention to detail a must. - Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities. - Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems. - Strong organization/prioritization skills for the management of multiple concurrent projects. - An understanding of Regulatory and Central/Local ethic submission processes - Ability to manage multiple competing priorities within various clinical trials. - Excellent verbal and written communication skills required. - Ability to work independently, prioritize, and work with a matrix team environment is essential. - Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required. - BENEFITS (full-time) Competitive salaryHealth InsuranceDental InsuranceDisability InsuranceLife InsurancePaid Time OffVision Insurance Wait benefits appear within Qualifications block? Actually after qualifications there is a line "BENEFITS (full-time) Competitive salaryHealth InsuranceDental InsuranceDisability InsuranceLife InsurancePaid Time OffVision Insurance". That seems misplaced; but we have a separate Benefits section later. We'll treat that as part of Benefits. Thus qualifications list ends before "Ability to travel for Clinic activities...". Actually after "Ability to work independently..." there is "Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required." That's still qualification. Then after that we see "BENEFITS (full-time) Competitive salaryHealth InsuranceDental InsuranceDisability InsuranceLife InsurancePaid Time OffVision Insurance". That's benefits. Thus qualifications list includes up to "Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required." Now Benefits: The line "BENEFITS (full-time) Competitive salaryHealth InsuranceDental InsuranceDisability InsuranceLife InsurancePaid Time OffVision Insurance". We need to split into list items: Competitive salary, Health Insurance, Dental Insurance, Disability Insurance, Life Insurance, Paid Time Off, Vision Insurance. Working Conditions: The paragraph after benefits: "This job operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites/clinics. This role routinely uses standard office equipment such as computers, phones, and scanners. There is frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment. Varied activities include standing, walking, reaching, bending, and lifting. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 50 pounds. Requires corrected vision and hearing to normal range. Due to the nature of this position, employees are expected to work in person. This is an exempt position under the federal and state wage and hour laws, which means you are not eligible for overtime pay beyond your salary. Employees are expected to work 40 hours a week. Occasional evening and weekend work may be required as job duties demand. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc." We need to remove boilerplate like "The above statements are intended..." and "More in-depth information can be found...". Also remove EEO etc earlier. Keep the substantive description. Thus Working Conditions paragraph should be: "This job operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites/clinics. This role routinely uses standard office equipment such as computers, phones, and scanners. There is frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment. Varied activities include standing, walking, reaching, bending, and lifting. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 50 pounds. Requires corrected vision and hearing to normal range. Due to the nature of this position, employees are expected to work in person. This is an exempt position under the federal and state wage and hour laws, which means you are not eligible for overtime pay beyond your salary. Employees are expected to work 40 hours a week. Occasional evening and weekend work may be required as job duties demand." We should also maybe include that it's exempt and 40 hours a week etc. That's substantive. Now we need to output only HTML fragment, no /, no markdown. We'll structure:

    About the role

    ...job summary...

    Responsibilities

    • ...
    • ...

    Qualifications

    • ...
    • ...

    Benefits

    • Competitive salary
    • Health Insurance
    • Dental Insurance
    • Disability Insurance
    • Life Insurance
    • Paid Time Off
    • Vision Insurance

    Working Conditions

    ...working conditions paragraph...

    We must ensure no duplicate content, no boilerplate. Check that we didn't include any mention of EEO, visa, etc. Now write the HTML. Let's craft the About the role paragraph: combine the two sentences: "The Senior CRC will work closely with Principal Investigators and clinical research teams to coordinate the daily operations of clinical research studies and oversee clinical research staff performing clinical functions at the designated Innovo Research partner site. The Senior CRC will be responsible for making sure that all clinical research activities are efficiently executed, and conducted in a professional manner that is compliant with all human research subject regulations. Experience in cardiology is preferred." Make sure spacing. Now Responsibilities list items as above. Check each item for completeness. Let's list them: 1. Assist with mentoring and training clinical research staff. 2. Perform clinical functions i.e. phlebotomy, monitoring vital signs on study participants, etc., when warranted; educate family and contribute to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria. 3. Liaises with agencies, pharmaceutical companies, laboratories, vendors, equipment, and supply companies as needed; oversees availability of supplies and/or equipment for studies. 4. Manage multiple

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