100%Remote Role || Clinical Research Specialist

Title:Clinical Research Regulatory Specialist

Client:Premier Inc.-

Visa:USC,GC

Location:100% remote – EST support Henry Ford in Detroit (Remote)

Duration:6+Months

Interview:Phone/Skype

Job description-

What will you be doing:

The Clinical Research Regulatory Specialist supports clinical research activities through the development of regulatory policies and protocol-specific documents including all reports for research activities from initial submission through study closure. The primary focus for this position is on development, submission, maintenance, filing and reporting of regulatory documents to achieve and maintain compliance with all internal, external, and federal policies and regulations pertinent to research involving human subjects.

This position is responsible for the management of the PAS Quality Management System, serves as the regulatory expert in the organization, provides regulatory guidance and direction through the leadership of the PAS Compliance Workgroup, and ensures compliance with all applicable policies, procedures, and regulations for clinical research.

Required Qualifications

Work Experience (do not edit):

3 Years Applicable Experience

Skills & Experience (top 3 skills):

•SOP development and compliance oversight

•GCP training and/or certification

•Audit preparation and conduct

•FDA regulated industry experience

•Pre-market regulatory affairs experience

•Quality Management System/Regulatory Compliance Program

•Independent judgment

•Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations

Education:

Bachelor’s Degree

Preferred Qualifications

Relevant Experience to include:

·Analytics

Education:

Master’s Degree

Major Accountabilities

Insert major accountabilities in chart

(HR/Recruiting: Enter marketing job description into Additional section of Workday)

Essential Function (*)

% of Time

(in descending order)

Area of Responsibility

100%

·Prepares, facilitates, and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for initial submissions, protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy

·Has GCP training and follows GCP guidelines and other guidelines related to the conduct of human subject’s research

·Develops and maintains departmental and study level SOPs in relation to clinical trials and according to FDA regulations and GCP guidance

·Coordinates review, approval, and dissemination of policies with the internal compliance committee

·Facilitates trial registration, results and reporting to sponsor and regulatory agencies such as the FDA, clinicaltrials.gov etc., in a timely manner consistent with federal regulations.

·Follows-up, communicates and facilitates responses to queries of the IRB, Sponsor, and other committees because of their review of submissions

·Coordinates the preparation and submission of all regulatory documents for a research study, including but not limited to consent forms, form 1572, IDE, and IND applications, in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research

·Work with sponsor to facilitate and coordinate the timely and accurate submission of safety date (AEs/SAEs), regulatory documents (hard copies and electronic binders) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents.

·Ensures that regulatory binders are audited and maintained

·Tracks status of pending protocols and associated supporting documents to provide efficient customer service to the Research team

·Helps to coordinate process, regulatory documents, queries and submissions during sponsor and FDA audits

·Leads the PAS Compliance Workgroup in the maintenance of PAS’s controlled documents (policies, SOPs, checklists, etc.)

·Supports in the preparation and conduction of vendor assessments and supports in the resolution of assessment findings/observations

·Ensures the PAS Quality Management System (QMS) is up to date per regulatory and sponsor requirements and maintains assessment/audit processes and documentation

Total

100%

Management Authority

Click either yes or no in the below table

Management Authority

Yes

No

Assign and direct work

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Correct and discipline

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Recommend salary increase

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Formally review performance

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Recommend promotions/discharge

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Interview and select employees

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Set or recommend new employees’ salary and hours of work

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Train employees

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Determine the means, methods, and materials for performing work

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Plan the work operations

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Physical Demands & Working Conditions

Insert physical demands below

Physical Demands

Lifting Requirement

Work

Description

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Sedentary

Exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves remaining stationary most of the time. Jobs are sedentary if movement is required only occasionally, and all other sedentary criteria are met.

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Light

Exerting up to 20 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the exertion of forces required is greater than that of sedentary work and if the worker remains stationary most of the time, the job is considered light work.

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Medium

Exerting up to 50 pounds of force occasionally, and/or up to 20 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.

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Heavy

Exerting up to 100 pounds of force occasionally, and/or up to 50 pounds of force frequently, and/or up to 20 pounds of force constantly to move objects.

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Very Heavy

Exerting more than 100 pounds of force occasionally, and/or more than 50 pounds of force constantly to move objects.

Physical Requirements

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Remain in a stationary position for prolonged periods of time

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Be adaptive and change priorities quickly; meet deadlines

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Attention to detail

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Operate computer programs and software

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Ability to communicate effectively with audiences in person and in electronic formats.

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Day-to-day contact with others (co-workers and/or the public)

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Making independent decisions

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Ability to work in a collaborative business environment in close quarters with peers and varying interruptions

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Ability to analyze data and develop presentations

Working Conditions

·Air conditioned, office space or remote

·Travel Required:

EEO Statement:Premier Inc.is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, color, sex, pregnancy, religion, national origin, ethnicity, citizenship, sexual orientation, age, marital status, disability, genetic information, status as a Vietnam Era, disabled veteran, special disabled veteran, Armed Forces Services Medal Veteran, recently separated or other protected veteran.

NOTE:This job description is not intended to be all-inclusive.Employee may perform other related duties to meet the ongoing needs of the organization.