CLINICAL RESEARCH COORDINATOR, SR
CLINICAL RESEARCH COORDINATOR, SR
DCI CANCER CONTROL (CPDC)
Screen participants independently and provide oversight and training to study team members who screen participants. May maintain subject level documentation for all studies independently. Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. 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. Improve systems related to specimen handling.
May 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. Train staff to maintain exemplary documentation including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc. Oversee maintenance of subject level documentation. Implement innovative solutions to maximize recruitment and retention Provide oversight to study team members who conduct and document consent for participants in a variety of studies. Serve as an expert resource with regard to conduct and documentation of consent. Provide direction to study teams with preparation for study monitoring or study audit visits.
Address and correct audit/monitor findings. Oversee the collection of adverse event information Direct study team's compliance with submission and completion of 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.
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. Develop documents related to safety and security (e.g., RDSPs, COIs, DSMPs). Coordinate efforts of external monitoring boards. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities for data flow plans for multiple studies. Independently design ECRFs and EDCs to collect data according to protocol. Select methods of data capture and discuss advantages and disadvantages of each. 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 Oversee the creation and use of queries, summaries, and reports. Recognize trends; escalate as appropriate. Develop and follow SOPs for data QA. Monitor QA of study data. Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)
Conduct literature reviews independently Determine operational/statistcal elements needed for the conduct of clinical and translational studies Assist with development of research proposals or protocols. Summarize and interpret study results, and determine application to future study procedures.
Actively network and encourage leadership for staff within a small work group. Take part in a committee, task force, or ad hoc group. Encourage career development by actively seeking out continuing education opportunities for self and study team members. Participate in scientific presentations and publications. Establish and assign activities to multiple team members. Provide constructive feedback to team members. Lead study teams with regard to clinical research professional guidelines and code of ethics. Identify potential problems and risks to the participant, study, investigator, team, sponsor, and institution. Maintain training requirements and develop solutions to proactively ensure study team members' compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
Study and Site Management:
Determine and implement alternative solutions to accomplishing recruitment and retention milestones. 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. Lead site initiation activities Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.Coordinate operational plans for multiple research studies. Take part in or lead closeout and document storage activities
Take action when communication has stalled with sites, CROs, sponsors. Responsible for items listed above, and in addition, recognize when team member communication is not going well and troubleshoot the issue.
Description of Portfolio and Clinical Responsibilities:
Type of Research
This person will oversee research protocols in smoking cessation - including investigator initiated studies with study drugs.
1202 CLINICAL RESEARCH COORDINATOR, SR
Job Family Level
Full Time / Part Time
Regular / Temporary
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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.
Work requires one of the following:1.Completion of a Bachelor's degree and a minimum of four years of research experience. 2.Completion of an Associates degree plus a minimum of six years of research experience. 3.Completion of a Master's degree and a minimum of 2 years of of research experience.
Management and leadership skills, strong attention to detail, experience with data management, excellent communication skills.
Auto req ID
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.