CLINICAL RESEARCH COORDINATOR, SR
CLINICAL RESEARCH COORDINATOR, SR
This position will be the Infectious Diseases Clinical Research Coordinator (CRC) team lead whose functions include both manager (lesser portion) and trial coordination.
Type of Research
This group participates in many industry, federally-funded and department-funded clinical research. Most of the clinical trials have extensive screening requirements and specimen collection/processing.
He/she must have significant experience with the conduct of clinical research at the institution and be an expert resource for the team. The ideal candidate will be an effective leader and manager. They should be willing to educate and assist team members, and be able to recognize when someone on the team needs help. They should be able to think strategically when trying to address the needs and concerns of the group.
- Screen potential study subjects independently and provide oversight and training to study team members who screen participants.
- Maintain subject- and visit-level documentation in the EMR and study databases for all studies independently Maintain exemplary study-level documentation, including regulatory binders, enrollment logs, and patient registration in the system of record, subject level documentation, etc. Provide oversight and training to study team members who perform this activity.
- Schedule study subjects and coordinate the conduct of all study-related visits (including protocol-specific testing/interviews) and provide oversight and training to study team members who perform this activity
- 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 and improve systems related to specimen handling.
- Assist with management of Investigational Products (IP), including devices and drugs. Employ the required system for handling, dispensing and documentation of IP and determine the best methods for handling IP for investigator-initiated protocols, or coordinate with investigational pharmacies as necessary. Track IP compliance at the protocol-and subject level.
- Conduct and document consent for participants in a variety of studies independently and provide training to others in these tasks.
- Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings.
- Collect and oversee the collection of adverse event information. Provide input for AE reports. Serve as a resource to junior staff as well as the unit, department, or division staff with regard to institution and sponsor-specific prompt reporting requirements (timelines and forms). Liaise with contact for final determination of safety event outcome.
- 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.).
- Serve as a resource to unit or department to help staff and subjects recognize the difference between clinical care and clinical management of research participants.
- Assure unit, division or department-wide training in ethical conduct of research.
- Serve as expert resource to study teams as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
- Articulate to study staff and research participants the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
- Predict areas of vulnerability for data flow for multiple studies or across a unit, department or division.
- Serve as unit/departmental/institutional resource on electronic case report and data capture technologies and software to ensure highest quality data collection and capture.
- May develop (or assist with development of) guidances and policies related to research data provenance and security and serve as unit/departmental resource to others regarding data provenance and security.
- Assist in the development of system/framework for QA processes for multiple studies or for entire unit, as well as oversee its implementation.
- Collaborate with various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation and testing of study aims.
- Assist with development of research proposals or protocols.
- 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.
- Establish and assign activities to multiple team members and provide constructive feedback to team members through yearly performance reviews. Manage time off reporting and study coverage.
- 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 unit, department, division's compliance with training requirements.
- Create strategies that enhance cultural diversity and cultural competency in the design and conduct of clinical research.
- Participate in or lead development of policies and guidances related to subject recruitment and serve as an expert resource across unit or department.
- Have familiarity with intellectual property rights, inventions patents, and technologies. As appropriate, understand regulations related to investigational products with sponsors.
Study and Site Management:
- Develop and oversee unit/department level processes to determine sponsorship, supervision or participation in trials.
- Provide expert guidance to study team members to ensure participant care expenses have been set up correctly and that financial charges/expenses route in a timely manner; troubleshoot, escalate, and resolve issues.
- Collaborate with the financial analyst to establish financial monitoring systems.
- Provide leadership/training to entire unit/department with regard to compliance with institutional requirements and other policies and work with sponsors and study teams to arrange required sponsor training.
- Provide ongoing feedback to the study team members; and serve as an institutional resource to the study visitors.
- Develop systems and documents including process flows, training manuals, and standard operating procedures to be used unit, department, or division-wide.
- Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors.
- Recognize when team member communication is not going well and troubleshoot the issue.
1202 CLINICAL RESEARCH COORDINATOR, SR
Job Family Level
Full Time / Part Time
Regular / Temporary
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.
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
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.