Clinical Research Coordinator

Deliverables :

Collect participant data; obtain informed consent / assent; respond to and report variances in protocol implement; collect and record research information, perform research procedures as qualified and assigned. - Ad-Hoc

Manage conflicts / issues in clinical research setting; assess participants and families; provide verbal responses to participants and families;

respond to inquiries from the general public and health care professionals regarding clinical research protocols. - Ad-Hoc

Contribute to interdisciplinary teams, participate in meetings, workgroup processes; provide substantive outcomes; complete assignments within established timeframes. - Daily

Educate participants and families; perform individualized teaching; advocate and support participants' rights; identify learning needs for practice environment;

explore and communicate research issues. - Ad-Hoc

Work products and documents related to protocol writing and editing; prepare amendments and all necessary forms; develop clinical research and clinical trial protocols, informed consent documents and other regulatory or study-related documents with special attention to the accuracy, consistency, and completeness of documents as well as proper format, spelling, and grammar (in conjunction with the PI and other relevant experts). - Daily

Work products and documents related to developing clinical documents; review and ensure that protocols and consents meet regulatory requirements and are written in a guideline compatible format. - Ad-Hoc

Work products and documents related to collaborating with staff on safety, regulatory and monitoring entities; coordinate with staff to integrate and ensure consistency of new / revised documents. - Ad-Hoc

Work products and documents related to managing, tracking and coordinating regulatory activities for the study protocols, under the guidance of the PIs, from conception / development, through the protocol lifecycle, to study closure. - Ad-Hoc

Work products and documents related to maintaining all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial;

work with staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies. - Ad-Hoc

Work products and documents related to the organization of regulatory protocol meetings and / or reports; interact closely with the clinical research team and other branch / section staff involved in protocol management;

guide the protocol navigation process. - Daily

Work Details :

Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices. 1

Prepare and submit for review accurate source documents related to all research procedures. 2

Prepare and submit Case Report Forms (CRFs) and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields. 3

Enter data into research databases, systems and applications for ongoing studies. 4

Assist researchers with study testing, observations data entry and other duties associated with study sessions. 5

Supports clinical staff develop, implement and maintain clinical research data files and materials.

Assist preparing and submitting for review accurate source documents related to all research procedures.

Assists clinical and research staff ensure that Case Report Forms (CRFs) are completed and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields.

Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).

Participate in developing and maintaining research protocol documentation and operations.

Maintains all professional certifications, if applicable.

Maintain a current clinical trial and clinical research study Good Clinical Practice GCP knowledge base, in order to serve as an expert resource to the client in a regularly changing field, and addresses identified knowledge and skill gaps related to role.

Attend in-person meetings located at the NIH campus in Bethesda or virtual meetings, including protocol development meetings, research coordinator forum meetings, as well as regular research team meetings.

Show initiative and strong independent problem-solving skills in making recommendations for improving research team processes in general, and as needed to efficiently resolve complex or unpredictable situations.

Identify inefficiencies and recommend changes to research protocol documentation procedures that can improve study productivity.

Minimum Education : Bachelor

Bachelor

Additional Qualifications :

Certifications & Licenses :

Association of Clinical Research Professionals Certified Professional (ACRP-CP)

Association of Clinical Research Professionals (ACRP)

Certified Clinical Research Professional (CCRP)

Certified Clinical Research Coordinator (CCRC)

Certified Clinical Research Associate (CCRA)

Field of Study :

Miscellaneous Health Medical Professions

Nursing

Community and Public Health

General Medical and Health Services

Neuroscience

Miscellaneous Biology

Cognitive Science and Biopsychology

Biology

Genetics

Health and Medical Preparatory Programs

Nutrition Sciences

Pharmacy Pharmaceutical Sciences and Administration

Treatment Therapy Professions

Communication Disorders Sciences and Services

Sociology

Miscellaneous Social Sciences

Miscellaneous Psychology

Clinical Psychology

Psychology

Social Work

Chemistry

Software :

Clinical Trial Management System (CTMS)

Electronic Medical Records System

Electronic Data Capture System

Skills :

Overseeing and documenting IP dispensing, inventory and reconciliation

Closing clinical trial sites down on completion of clinical trial

Ordering, tracking, and managing IP and trial materials.

Implementation of clinical trial site action plans

Training clinical trial site staff

Coordinating project meetings

Previous clinical trial work

Electronic medical records

Protocol review revision.

Phase I or II experience.

Patient confidentiality

Remote site monitoring

Regulatory compliance

Protocol development.

Clinical Research

Protocol writing.

Clinical Trials

Data Monitoring

Data Integrity

Patient care

Recruitment

Scheduling

Research

ICH / GCP

SOPs

Liaising with regulatory authorities

Liaise with ethics committee.

Protocol navigation.

Regulatory affairs

IRB submissions