Clinical Research Manager

Employer
Midwestern University
Location
Edgewater Terrace, IL
Posted
Sep 13, 2021
Closes
Sep 16, 2021
Ref
2451220502
Sector
Other
Organization Type
Corporate
Summary: The Clinical Research Manager is a full-time position on the Glendale, AZ campus that reports to the Director of Clinical Research Services (CRS), Glendale. This position will be focused on the management and execution of clinical research studies and associated contracts, budgets, grants, SOPs, and data analysis. The Clinical Research Manager will serve as a liaison with external partners that support research and training. The Clinical Research Manager will coordinate research studies including but not limited to scheduling subject visits, completing source and case report form documentation, maintaining regulatory documents, and preparing and hosting monitoring visits. The Clinical Research Manager will be responsible for creating protocols, budgets, study reports and presentations, preparing manuscripts, preparing and coordinating grant submissions, and working with study team personnel, students, residents, faculty, external investigators, and sponsors. The Clinical Research Manager will also assist in preparing and complying with standard operating procedures (SOPs) and the development of processes and procedures within CRS. Although this position will be based at CRS Glendale Campus, this individual will be expected to maintain a presence at local external research sites (up to 50% or more) and travel to remote clinical trials sites, with occasional travel to the Illinois campus, meetings with sponsors, and conferences.

Duties and Responsibilities

Project Management, Reports, and Technical Writing
  • Facilitate processing of contracts, regulatory documentation, and other requirements for study activation.
  • Provide general project management support for research projects, including the development of timelines, critical path (series and parallel processes), and checklists.
  • Produce progress reports and prepare respective presentation materials.
  • Perform literature reviews and create study related abstracts and manuscripts.
  • Ability to write peer-reviewed clinical research manuscripts.
  • On occasion, identify grant opportunities and prepare grant submissions.
  • Assist and participate in case study reviews, abstract submissions, article reviews, and manuscript preparation with faculty, residents, and students.

General Clinical Responsibilities
  • Assist faculty, residents, and students with all aspects of developing clinical research projects and help bring them to fruition, both within Midwestern colleges and with external partners.
  • Draft and/or review study designs, protocols, study proposals and study associated budgets.
  • Serve as an investigator or study team member on clinical trials. In this capacity, the Clinical Research Manager may be required to obtain vital signs, set catheters, obtain biospecimens (blood, urine, biopsies, etc.), prepare and administer study drug based on training and clinical experience.
  • Manage and monitor clinical projects occurring on campus and at external trial sites, including scheduling and preparing for patient visits, patient screening and enrollment, data collection, biospecimen collection/processing, data tabulation, and data entry.
  • Serve as the liaison between MWU CRS and the sponsor by working with the sponsor's clinical monitors/clinical research personnel ("Medical Monitors") to facilitate communications for all active protocols.
  • Perform timely and accurate recording of patient/subject data into the medical record (source document) and transmission of data (case reports, etc.) to the sponsor or sponsor's contract research organization (CRO).
  • Process and gather data concerning sponsor data queries and submit to appropriate agency for resolution.
  • Randomize subjects and record visits in interactive voice/web recording system (IVRS/IWRS).
  • Track medication supply, compliance, and accountability.
  • Ensure patient/subject research confidentiality issues are addressed according to Health Insurance Portability and Accountability Act of 1996 (HIPAA).
  • Maintain relationships with external clinical trial sites including frequent visits for study coordination.
  • Monitor / audit studies in accordance to study specific protocols and standard operating procedures.
  • Create and maintain regulatory and patient binders for each study protocol, ensuring that documents are current and ready for monitor / audit visits, medical licenses of PIs and Sub-Is are up to date, and training logs, drug logs, and other documents are up to date and accurate.
  • Assist in submitting and tracking adverse events and safety reports.
  • Assist faculty and personnel in preparing for site initiation, qualification, and monitoring visits.
  • This position may involve periodic work with and exposure to companion animals.

General Bench Research Responsibilities
  • Coordinate and/or perform sample analysis using analytical equipment (CBC, Chemistry, etc.), ELISA, HPLC-MS, microbial culturing and isolation, and other bench or analytical procedures to analyze biospecimen samples.

Other
  • Travel for offsite research trials, conferences, Sponsor meetings, CE and training (up to 10%).
  • Maintain and order research supplies and materials (catheters, infusion sets, etc.).
  • Obtain investigator and/or sponsor feedback concerning satisfaction with CRS performance.
  • Carry out additional duties as assigned by the Director of CRS. May be required to conduct other administrative duties to support CRS staff including but not limited to proofreading documentation for accuracy and syntax.
  • Other duties may be assigned

Supervisory Responsibilities

This position will have supervisory responsibilities.

Qualifications

To perform this job successfully, an individual must be organized, a good communicator, resourceful, and able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. This individual must be able to work in a constant state of alertness and safe manner and have regular, predictable, in-person attendance. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience writing up clinical research for peer-reviewed publications is desired.

Education and/or Experience

Bachelor's degree is required with advanced degree (e.g., nurse, PA, CNP, PharmD, MD, DO) preferred. Must have 7-10 years of experience related to clinical research or clinical experience as a nurse, physician assistant, pharmacist, certified nurse practitioner or physician. 3 years of previous clinical research experience is preferred.

These additional skills are also desired: bench research experience, phlebotomy experience, and having served as a co-author on publications and/or abstracts.

Technical Writing Skills

Ability to create study designs, protocols, study reports, abstracts and manuscripts is preferred. Firm understanding of literature review, technical writing, and citing publications strongly desired.

Computer Skills

Computer proficiency in MS Office (Word, Excel, Outlook, Access). Familiarity with project management software (any) desired.

Language Skills

Intermediate skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees of the organization.

Reasoning Ability

Intermediate skills: Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving se veral concrete variables in standardized situations.

Mathematical Ability

Basic skills: Ability to add, subtract, multiply, and divide all units of measure using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to interpret bar graphs.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position may require direct interaction dogs, cats, horses, livestock, so this individual should not have allergies to dogs, cats, horses, or livestock that would prohibit such activities.

While performing the duties of this job, the employee is occasionally required to stand. The employee is regularly required to walk; reach with hands and arms. The employee is frequently required to sit, use hands to finger, handle, or feel; talk and hear. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close and distance vision.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position may occasionally be exposed to fumes or airborne particles and exposed to outdoor weather conditions. The noise level in the work environment is usually moderate.

Midwestern University is an Equal Opportunity/Affirmative Action employer that does not discriminate against an employee or applicant based upon race; color; religion; creed; national origin or ancestry; ethnicity; sex (including pregnancy); gender (including gender expressions, gender identity; and sexual orientation); marital status; age; disability; citizenship; past, current, or prospective service in the uniformed services; genetic information; or any other protected class, in accord with all federal, state and local laws, including 41 C.F.R. 60-1.4(a), 250.5(a), 300.5(a) and 741.5(a). Midwestern University complies with the Smoke-Free Arizona Act (A.R.S. 36-601.01) and the Smoke Free Illinois Act (410 ILCS 82/). Midwestern University complies with the Illinois Equal Pay Act of 2003 and Arizona Equal Pay Acts.

Job Requirements:

Duties and Responsibilities

Project Management, Reports, and Technical Writing
  • Facilitate processing of contracts, regulatory documentation, and other requirements for study activation.
  • Provide general project management support for research projects, including the development of timelines, critical path (series and parallel processes), and checklists.
  • Produce progress reports and prepare respective presentation materials.
  • Perform literature reviews and create study related abstracts and manuscripts.
  • Ability to write peer-reviewed clinical research manuscripts.
  • On occasion, identify grant opportunities and prepare grant submissions.
  • Assist and participate in case study reviews, abstract submissions, article reviews, and manuscript preparation with faculty, residents, and students.

General Clinical Responsibilities
  • Assist faculty, residents, and students with all aspects of developing clinical research projects and help bring them to fruition, both within Midwestern colleges and with external partners.
  • Draft and/or review study designs, protocols, study proposals and study associated budgets.
  • Serve as an investigator or study team member on clinical trials. In this capacity, the Clinical Research Manager may be required to obtain vital signs, set catheters, obtain biospecimens (blood, urine, biopsies, etc.), prepare and administer study drug based on training and clinical experience.
  • Manage and monitor clinical projects occurring on campus and at external trial sites, including scheduling and preparing for patient visits, patient screening and enrollment, data collection, biospecimen collection/processing, data tabulation, and data entry.
  • Serve as the liaison between MWU CRS and the sponsor by working with the sponsor's clinical monitors/clinical research personnel ("Medical Monitors") to facilitate communications for all active protocols.
  • Perform timely and accurate recording of patient/subject data into the medical record (source document) and transmission of data (case reports, etc.) to the sponsor or sponsor's contract research organization (CRO).
  • Process and gather data concerning sponsor data queries and submit to appropriate agency for resolution.
  • Randomize subjects and record visits in interactive voice/web recording system (IVRS/IWRS).
  • Track medication supply, compliance, and accountability.
  • Ensure patient/subject research confidentiality issues are addressed according to Health Insurance Portability and Accountability Act of 1996 (HIPAA).
  • Maintain relationships with external clinical trial sites including frequent visits for study coordination.
  • Monitor / audit studies in accordance to study specific protocols and standard operating procedures.
  • Create and maintain regulatory and patient binders for each study protocol, ensuring that documents are current and ready for monitor / audit visits, medical licenses of PIs and Sub-Is are up to date, and training logs, drug logs, and other documents are up to date and accurate.
  • Assist in submitting and tracking adverse events and safety reports.
  • Assist faculty and personnel in preparing for site initiation, qualification, and monitoring visits.
  • This position may involve periodic work with and exposure to companion animals.

General Bench Research Responsibilities
  • Coordinate and/or perform sample analysis using analytical equipment (CBC, Chemistry, etc.), ELISA, HPLC-MS, microbial culturing and isolation, and other bench or analytical procedures to analyze biospecimen samples.

Other
  • Travel for offsite research trials, conferences, Sponsor meetings, CE and training (up to 10%).
  • Maintain and order research supplies and materials (catheters, infusion sets, etc.).
  • Obtain investigator and/or sponsor feedback concerning satisfaction with CRS performance.
  • Carry out additional duties as assigned by the Director of CRS. May be required to conduct other administrative duties to support CRS staff including but not limited to proofreading documentation for accuracy and syntax.
  • Other duties may be assigned

Similar jobs

More searches like this

Similar jobs