CLINICAL RESEARCH COORDINATOR, SR - SON

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

CLINICAL RESEARCH COORDINATOR, SR - SON
SON-FACULTY AND STAFF

Occupational Summary

This position will have oversight over a grouping of research studies at the SON and will be responsible for study operations which may include hiring/managing staff or actually taking on recruitment /consenting on one if needed. This position will be instrumental in study start up procedures for new, large grants. Will over see progress of milestones and study operations for studies. This position reports directly to the Research Practice Manager.

Essential Duties

1. Operations
a. Provide oversight and training to entire unit or department with regards to subject screening. Set up unit-wide systems, policies related to subject screening.
b. Provide oversight and training to entire unit or department with regards to maintaining subject level documentation. Set up unit-wide systems, policies related to subject level documentation.
c. Responsible for organization and startup of new large funded grants. Serve as a unit/departmental resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans on new large studies.
d. Create, optimize, and oversee systems to collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
e. 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. Participate in or lead development of policies and guidances related to subject recruitment. Serve as an expert resource across unit or department.
f. 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.
g. Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings.
h. 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.
i. Serve as a unit, department, or division resource for development of IRB documents and for guidance on IRB communications

2. Ethics
a. Serve as a resource to unit or department to help staff and patients recognize the difference between clinical care and clinical management of research participants
b. Assist in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Assist others with application of these principles.
c. Develop documents related to safety and security (e.g., RDSPs, COIs, DSMPs). Coordinate efforts of external monitoring boards.
d. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.

3. Data
a. Predict areas of vulnerability for data flow for multiple studies or across a unit, department or division.
b. Design data flow plans that include elements related to data capture, storage, management, quality, and preparation for analysis; implement across multiple studies or at unit, department or division level. Serve as unit/departmental/institutional resource on ECRFs, EDCSs, technologies, and software to ensure highest quality data collection and capture.
c. Recommend and lead implementation of processes, policies, and systems to ensure data security and data provenance.
d. Oversee the creation and use of queries, summaries, and reports. Recognize trends; escalate as appropriate.
e. Develop quality assurance systems for research data; ensure that QA SOPs are updated and followed by study teams. Implement quality assurance systems across multiple studies, or across entire unit, department or division. reports. Recognize trends; escalate as appropriate.
f. Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)

4. Science
a. Develop research proposals or protocols with little assistance; Identify operational shortcomings of proposals and protocols.
b. Summarize study results.

5. Leadership
a. Actively network and encourage leadership for staff within a small work group. Take part in a committee, task force, or ad hoc group.
b. Encourage career development by actively seeking out continuing education opportunities for self and study team members.
c. Participate in scientific presentations and publications.
d. Serve as expert mentor to junior staff.
e. Establish and assign the activities of multiple teams to accomplish study goals.
f. 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.
g. Maintain training requirements and develop solutions to proactively ensure study team members' compliance with training requirements.

6. Study and Site Management
a. Determine and implement alternative solutions to accomplishing recruitment and retention milestones.
b. 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.
c. 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.).
d. Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
e. Take part in site initiation and closeout meetings independently
f. 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.
g Take part in or lead closeout and document storage activities

7. Communication
a. Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.
b. Prepare for and lead team meetings.
c. Recognize when others need to be brought into the conversation and escalate appropriately.
d. Expand on the ideas of peers or team members. Take an active role in including others in decision-making.

8. Miscellaneous
a. Follow Duke procedures in regards to collecting IRB Data Disclosure form and requirements around SSN# storage and payment processing.
b. Maybe required to step in as a study CRC when necessary.
c. Perform other related and requested duties incidental to the work described herein.
d. Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Requisition Number
401227575

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1202 CLINICAL RESEARCH COORDINATOR, SR

Job Family Level
53

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 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.

Education

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

87077BR

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.

PI97510147