Clinical Research Specialist, Sr.

Duke Careers•Durham, NC

1d•$21 - $31•Onsite

About The Position

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations. This Clinical Research Professional (CRP) will participate in research conducted by the Division of Gastroenterology in the Department of Medicine under the supervision of the Principal Investigator(s) of the Gastroenterology Research Program. This CRP will perform a variety of research, data, and clerical duties to support conduct of clinical research under direct daily supervision of Clinical Research Coordinator (CRC) or Clinical Research Unit (CRU) designee. CRP duties may include screening, consenting to minimal risk studies, data collection, sample collection/processing/shipping, query resolution, participant payment processing, filing, data extraction and reporting, scheduling and order/manage supplies. The CRP will be integrated into a larger clinical research team and is expected to collaborate on studies that will further the research mission of the Gastroenterology program. The Principal Investigators will provide supervision, regulatory oversight, mentorship, and guidance in the conduct of research.

Requirements

Knowledgeable in regulatory and institutional policies and processes.
Under supervision, assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering).
Under supervision, prepares for study monitoring and audit visits.
Maintains participant-level documentation for minimal risk (e.g., questionnaire, data registry, scripted) studies.
Follows SOPs and strategies to manage and retain research participants.
Recruits research participants according to study protocol.
Screens participants in person or over the phone for minimal risk studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility.
Follows SOPs.
Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
Assists with establishing and maintaining study level documentation.
Schedules participants for research visits.
Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol.
Conducts and documents minimal risk study visits and scripted testing or interviews.
May manage participant payment.
Participates in study team meetings.
Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team.
Conducts and documents consent for participants in minimal risk studies, as defined by the IRB.
These studies may include protocols with blood draws, repositories, survey studies, simple observational studies, and studies that do not involve investigational products or devices.
Not permitted to tee up orders for second signature in Maestro Care.
Assists with the development of consent plans and documents for participants.
Under supervision, develops and submits documentation and information for IRB review.
Assist with the compilation of documents needed for regulatory and safety reporting to sponsors and other agencies.
Enters and collects basic data for research studies.
May score scripted or validated tests and measures.
Independently corrects and documents incomplete, inaccurate or missing data for minimal risk studies.
Follows SOPs for quality assurance.
Runs summaries and reports on existing data.
Follows required processes, policies, and systems to ensure data security and provenance.
In addition, recognizes and reports security of physical and electronic data vulnerabilities.
Follows requirements for depositing data into an appropriate repository and meta-data specifications for data sharing.
With guidance, locates and follows repository-specific requirements to submit study data for sharing.
Follows requirements for use of data standards for developing research databases. (E.g. IDC 10, CDISC, MedDRA, and WHODrug).
Learns and uses new technology when required.
Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants.
Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators.
Assists with simple literature searches.
Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies).
Demonstrates a basic understanding of the elements of research study designs.
Provides some contribution to scientific publications or presentations.
As directed, attends or schedules site visits.
Records participant accrual information and consent documentation for minimal risk studies in clinical research management system.
Records basic protocol information in clinical research management system.
For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.
Ensure that studies are conducted in compliance with institutional requirements and other policies.
Follows protocol-specific systems and process flows.
As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
Works with the manager to understand areas of opportunity and develop a training plan.
Takes training courses and applies the knowledge and skills.
May also train others in the skills learned.
Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.).
Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
Demonstrates resilience and is adaptive to change.
Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
Perform a variety of research, data, and clerical duties to support conduct of clinical research under direct daily supervision of Clinical Research Coordinator (CRC) or Clinical Research Unit (CRU) designee.
CRP duties may include screening, consenting to minimal risk studies, data collection, sample collection/processing/shipping, query resolution, participant payment processing, filing, data extraction and reporting, scheduling and order/manage supplies.
The CRP will be integrated into a larger clinical research team and is expected to collaborate on studies that will further the research mission of the Gastroenterology program.
The Principal Investigators will provide supervision, regulatory oversight, mentorship, and guidance in the conduct of research.

Responsibilities

Assist with study documentation, protocol submissions, and standard operating procedures (SOPs).
Assist with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering).
Prepare for study monitoring and audit visits.
Maintain participant-level documentation for minimal risk studies.
Manage and retain research participants according to SOPs and strategies.
Recruit research participants according to study protocol.
Screen participants in person or over the phone for minimal risk studies or may collect information from the EHR to assist study team in determining eligibility.
Employ simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
Assist with establishing and maintaining study level documentation.
Schedule participants for research visits.
Prepare necessary documents, equipment, supplies, etc. in compliance with the protocol.
Conduct and document minimal risk study visits and scripted testing or interviews.
Manage participant payment.
Participate in study team meetings.
Recognize known potential adverse events and report to study team.
Conduct and document consent for participants in minimal risk studies.
Assist with the development of consent plans and documents for participants.
Develop and submit documentation and information for IRB review.
Assist with the compilation of documents needed for regulatory and safety reporting to sponsors and other agencies.
Enter and collect basic data for research studies.
Score scripted or validated tests and measures.
Correct and document incomplete, inaccurate or missing data for minimal risk studies.
Perform quality assurance according to SOPs.
Run summaries and reports on existing data.
Ensure data security and provenance.
Recognize and report security of physical and electronic data vulnerabilities.
Deposit data into an appropriate repository and follow meta-data specifications for data sharing.
Locate and follow repository-specific requirements to submit study data for sharing.
Follow requirements for use of data standards for developing research databases.
Learn and use new technology when required.
Assist in preparing tables, data visualizations, and lay summaries to communicate study results to participants.
Assist in updating and may develop reports on study progress for the PI and other study team members and collaborators.
Assist with simple literature searches.
Develop elements of research protocols for simple studies.
Provide some contribution to scientific publications or presentations.
Attend or schedule site visits.
Record participant accrual information and consent documentation for minimal risk studies in clinical research management system.
Record basic protocol information in clinical research management system.
Ensure that there are ample supplies and that equipment is in good working order for studies with simple supplies or equipment.
Ensure that studies are conducted in compliance with institutional requirements and other policies.
Follow protocol-specific systems and process flows.
Assist in preparing studies for closeout.
Work with the manager to understand areas of opportunity and develop a training plan.
Take training courses and apply the knowledge and skills.
Train others in the skills learned.
Keep current with research updates by attending key external departmental meetings.
Navigate processes and people involved in Duke clinical research.
Demonstrate organizational awareness and interpersonal skills necessary to get work done efficiently.
Demonstrate resilience and adaptability to change.
Communicate effectively with others to accomplish shared work objectives.