CLINICAL RESEARCH COORDINATOR

Location
Durham, NC
Posted
Apr 13, 2017
Institution Type
Four-Year Institution

CLINICAL RESEARCH COORDINATOR
Head and Neck Surgery Communications Sci

Occupational Summary:
Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff.

Work Performed
1.Clinical research operations. Screen, schedule, consent, and collect adverse event information for participants in a variety of studies.
  • Maintain subject level documentation, including documentation of consent in the electronic medical record.
  • Prepare documents, equipment, or supplies for research visits.
  • Conduct and document visits and protocol- specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently.
  • Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
  • Evaluate processes to identify issues related to recruitment and retention rate.
  • Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks; improve systems related to specimen handling.
  • Develop or provide input for Institutional Review Board documents such as consent forms, protocols, and continuing reviews in a timely fashion.
  • Maintain or collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
  • Assist with management of Investigational Products (IP) including arrival, storage, handling, requesting requisitions, inventory, reordering, drug accountability, reconciliation, and destruction.
  • 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.
  • Collect, prepare, or process adverse event information per protocol, and provide input for adverse event reports.
  • May complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms).
  • 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.).

2.Ethical and participant safety considerations.
  • Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research with vulnerable populations.
  • Train junior staff in the ethical conduct of research, dealing with vulnerable populations, and provide guidance in strategies used to maintain safety.
  • May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
  • Communicate to research participants, both orally and written, the difference between clinical activities and research activities, and the risks and benefits of study participation, in all study documents and research participant communications.
  • May make recommendations regarding how to improve communications to help patients and staff understand the distinction.

3.Data management and informatics.
  • Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations.
  • Score tests and measures according to protocol and appropriate to role.
  • Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol.
  • Assist with the development of data collection documents to standardize process.
  • May independently design ECRFs and EDCs to collect data and select methods of data capture and discuss advantages and disadvantages of each.
  • Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance.
  • May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes.
  • May be responsible for recognizing trends related to data quality and escalating as appropriate.
  • Use required processes, policies, and systems to ensure data security and data provenance.
  • 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.
  • Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place (e.g., data use agreements, data transfer agreements, Investigational Device Exemptions (IDEs), etc.).

4.Scientific concepts and research design.
  • Understand and train others in the basic concepts of study design.
  • Independently conduct literature reviews.
  • Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.
  • May determine operational/statistical elements needed for conduct of clinical and translational studies.

5.Leadership and professionalism.
  • Encourage and support colleagues to complete project work.
  • Assist research colleagues in identifying efficiencies and improving process.
  • Successfully take part in or lead a committee, task force, or ad hoc group.
  • Encourage career development by actively seek out continuing education opportunities for self and study team members.
  • Assign, review, and train others in various work responsibilities.
  • Serve as a mentor to junior staff, including other Clinical Research Coordinators.
  • Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
  • Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
  • May be responsible for identifying potential problems and risks to the participant, study, investigator, team, sponsor, and institution.
  • Study and site management.
  • Participate in sponsor-required training.
  • Obtain information for or coordinate operational plans for multiple research studies.
  • Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
  • 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.

6.Communication and team science.
  • Prepare for and lead team meetings.
  • Recognize when others need to be brought into the conversation and escalate appropriately.
  • Serve as primary liaison with single sponsor, subcontractor, or vendors.
  • Communicates concerns clearly and in a professional manner. K

Knowledge, Skills and Abilities:
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Requisition Number
401198694

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, genetic information, gender, gender identity, national origin, race, religion, sexual orientation, or veteran status. ******************************************************* 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)

Auto req ID

85315BR

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

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.

PI97510032