Clinical Research Coordinator

Location
North Carolina, United States
Posted
20 Nov 2018
End of advertisement period
20 Jan 2019
Ref
401505446
Contract Type
Permanent
Hours
Full Time

Job Description

Operations:

  • Screen participants for all studies independently.
  • Maintain subject level documentation for all studies independently
  • Schedule participants and conduct visits for all studies independently.
  • Train others to conduct and document visits and protocol-specific testing/interviews.
  • Assist with development and follow procedures and documentation of study payment in timely fashion.
  • Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
  • Assist with management of IP. Employ the required system for handling, dispensing and documentation of IP for sponsored protocols.
  • May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary.
  • Maintain appropriate documentation. Track IP compliance at the protocol-and subject level.
  • Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
  • Implement innovative solutions to maximize recruitment and retention Conduct and document consent for participants in a variety of studies independently and provide training to others in these tasks.Assist with addressing and correcting findings from study monitoring and study audit visits.
  • Collect,prepare or process adverse event information independently Complete and submit AE Reports,according to institution and sponsor-specific prompt reporting requirements (timelines and forms)independently.
  • Have familiarity with intellectual property rights,inventions patents, and technologies. As appropriate, understand regulations related to investigational products with sponsors.
  • Coordinate with Duke core services such as Investigational Drug Service (IDS),Biobank, etc.
  • Recognize the need for agreements (e.g., Material Transfer Agreements,Investigational New Drug Applications, etc.).
  • Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently and train other staff in these tasks.

Ethics:

  • Recognize when patients are having difficulties with this distinction.
  • Make recommendations regarding how to improve communications to help patients and staff understand the distinction.
  • Train junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety.
  • Assist with the development of Conflict of Interest(COI)/ Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs).
  • Assist with the coordination of efforts of external monitoring boards. I
  • dentify and the explain the risk and benefits to a subject as these pertain to your clinical trial

Data:

  • Map protocol data flow.
  • Predict areas of vulnerability for a protocol's data flow plan.
  • Determine areas where data provenance may be compromised.
  • Train others on study team in use of technologies and software, and in completion of ECRFs.
  • Assist with the development of data collection documents to standardize process. Use EDC systems and enter data accurately.
  • Recognize and report vulnerabilities related to security of physical and electronic data.
  • Suggest and implement solutions to vulnerabilities related to security of data and data provenance Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.
  • Run summaries and reports on existing data Develop and follow SOPs for data QA.
  • Monitor QA of study data. Recognize when data agreements are necessary

Science:

  • Conduct literature reviews independently Identify various stakeholders(statistical, operational,etc.) to ensure adequate design, implementation, and testing of study aims.
  • Assist with development of research proposals or protocols.

Leadership:

  • Encourage and support colleagues in completing project work.
  • Assist research colleagues in identifying efficiencies and improving process. Assign, review, and train others in various work responsibilities.
  • Serve as a mentor to junior staff, including others with my title. Employ escalation and performance plans as needed.
  • Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
  • Maintain training requirements and develop solutions to proactively ensure study team members' compliance with training requirements.

Study and Site Management:

  • Collect information to determine appropriate feasibility, recruitment and retention strategies.
  • Ensure participant care expenses have appropriate financial routing in a timely manner.
  • Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc.and participate in budget development as appropriate.
  • Assist with study budgets. Maintain study's compliance with institutional requirements and other policies (e.g.,NIH Public Access policy,ct.gov, Research Data Security Plans, Social Media policy, etc.) 
  • Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
  • Take part in site initiation and closeout meetings independently Recognize components of operational plans and be able to obtain information needed to develop the plan.
  • Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
  • Take part in or lead closeout and document storage activities

Communication:

  • Serve as primary liaison with single sponsor, subcontractor, or vendors.
  • Communicate concerns clearly and in a professional manner.
  • Participate in study team meetings.
  • Respond to routine questions related to study protocol and refer more complex questions to others as appropriate.
  • Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.

Description of Portfolio and Clinical Responsibilities:

Portfolio Management (Effort %):

Clinical responsibilities:

Other:


Type of Research This Gastroenterology NAFLD CRC will be responsible for identifying eligible study participants,providing informed consent, collecting data, performing study visits,in compliance with sponsor,regulatory, and institutional guidelines.
Study types include industry, federal, and investigator initiated. In addition to recruiting within GI clinics, this position will liaise with other clinics to maximize subject recruitment. This position will report directly to the CRC, Sr.

Special Skills

  • Candidate will possess exquisite communication skills, ability to work in teams, as well as perform autonomously.
  • Candidate will have basic computer knowledge, including MS Office and calendaring.
  • Previous research experience preferred, but not required. ACRP or SOCRA certification suggested at earliest eligibility.

Requisition Number 401505446
Location Durham
Duke Entity MEDICAL CENTER
Job Code 1201 CLINICAL RESEARCH COORDINATOR
Job Family Level 52
Exempt/Non-Exempt Exempt
Full Time / Part Time FULL TIME
Regular / Temporary Regular
Shift First/Day

Minimum Qualifications

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex,sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation,creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions:

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Education

  1. Completion of a Bachelor's degree.
  2. Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination).

Special Skills

  • Candidate will possess exquisite communication skills, ability to work in teams, as well as perform autonomously.
  • Candidate will have basic computer knowledge, including MS Office and calendaring.
  • Previous research experience preferred, but not required. ACRP or SOCRA certification suggested at earliest eligibility.

Auto req ID

105829BR