UnityPoint Health

Research Regulatory Specialist

Requisition ID
2017-37196
Category
Research
US-IA-Cedar Rapids
202 10th St SE
Affiliate
1010 UnityPoint Health CR St Lukes Hospital
Cedar Rapids
Department
Helen G Nassif Comm Cancer
IA
Salary Minimum
USD $21.82/Hr.
FTE
0.9
FLSA
Non-Exempt
Scheduled Hours/Shift
Days - Flexible

Overview

Research Regulations Specialist oversees the daily regulatory activities for research studies and coordinates and performs administrative research protocol support services. The Research Regulations Specialist assists in the creation, maintenance and utilization of databases containing clinical, financial, and other outcome data.


Responsibilities

Coordinates and prepares documents for implementation of clinical trials including:

  • Corresponds with various research organizations regarding the initiation of research studies and of related records; completes and submits documents as appropriate.
  • Submission of appropriate Human Service Review forms and application materials.
  • Assists in preparing reports for analysis and submission to study sponsors.
  • Organizes contract trial agreements, budgets and confidentiality disclosures for all studies.
  • Responds to program correspondence, including inquiries and requests for protocol information.

 

Publishes and distributes information to all sub-investigators notifying them studies open for enrollment. Develops study summaries for sub-investigator education.

 

Maintains internal and external databases as assigned.

  • Assumes responsibility for accuracy and retention of data by auditing, archiving, backup, proofing reports, protection against alterations and other mechanisms as appropriate.
  • Apprises departmental personnel of any significant findings or problems identified during database maintenance or data submission.
  • Complies with measure to maintain database security and confidentiality.
  • Follows established policies and procedures for release of data.
  • Identifies data that can be retrieved
  • Imports and exports information from clinical to financial related systems and databases when necessary
  • Constructs queries as directed
  • Constructs databases as directed
  • Maintains access to internal and external databases in accord with system or contractual requirements.
  • Crosschecks and combines data with other databases as appropriate
  • Acts as a resource in the capture of data that is valid, reliable, and quantifiable.

 

Coordinates and prepares for monitoring visits for industry-sponsored studies and audits.

 

Maintains spreadsheet for tracking incoming related to research activities.

 

Compiles accrual data for protocols, reviews and summarizes information for research team, Institutional Review Boards and local hospitals as needed for their reports.

 

Prepares agenda for monthly local IRB meetings to submit new studies, annual reviews, amendments and modifications.

 

Prepares necessary forms for the FDA Investigation of New Drug applications; submits Adverse Events and Safety Reports to Institutional Review Board; submits UI Laboratory Certification forms and all other regulatory request to sponsors and National Cancer Institute, submit detailed letters of correspondence to the Institutional Review Board.

 

Assures appropriate routing procedures and signature approval requirements are met for industry and National Cancer Institute sponsored budgets and grants.

 

As appropriate, develops and maintains tracking databases to assure timely reporting of required documents to regulatory bodies and study sponsors. Ensures accurate and timely data collection and entry into databases as indicated by department guidelines.

 

Prepares clear, concise, attractive reports using spreadsheets, word processing, graphic and presentation software as

directed.

 

Participates in the development, implementation and evaluation of policies and procedures.

 

Commitment to co-workers

  • Facilitates cooperative formal and informal working relationships with inpatient and outpatient departments and medical staff as necessary.
  • Demonstrates flexibility and self-direction in meeting patient and department needs by responding as a team player.
  • Assists in the orientation of new associates by serving as a resource and mentor to associates.
  • Provides professional leadership through compliance with established department routines, policies and procedures.
  • Assists in creating positive work environment that contributes to safety and positive outcomes.
  • Participates in mandatory education and staff meetings, per established guidelines.

 

Establishes professional competence through the processes of continuing education, professional organization involvement and in services.  

  • Evidences ability to apply professional judgement when working with study sponsors, regulatory agencies and patients and families.
  • Possesses an acceptable knowledge of professional terms and concepts.
  • Prepares meaningful, concise and data reports.
  • Continually expands own knowledge and other staff on current resources available.
  • Consistently seeks professional growth opportunities.
  • Acquires additional certifications as indicated.

 

Performs other duties as assigned.


Qualifications

Education

  • Baccalaureate degree required in field of health, science, math or related.
  • College course work in computers required or job-related training.

 

Qualifications/Experience

  • Knowledge of medical terminology preferred.
  • Experience with use of Word, Excel, PowerPoint and Access databases.
  • Experience with data entry required.
  • Experience organizing multiple tasks.
  • Ability to work independently and self-direct work activities.
  • Detail oriented and able to meet established deadlines.

 

Special Skills/Knowledge

  • Experience with Microsoft products required.
  • Experience with database development and maintenance preferred.
  • Possesses excellent communication and interpersonal skills to establish a high degree of rapport and professional interaction with providers and peers.
  • Maintains strict confidentiality at all times.
  • Ability to communicate with multiple levels of organizations and community (managers, physicians, clinical, and support staff).
  • Possesses a broad and varied knowledge base that is continually enhanced and updated through self-directed study and participation in educational opportunities, with experience/emphasis in IRB regulatory requirements desired.

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