Clinical Research Coordinator - Bethesda, United States - GAP Solutions, Inc. (GAPSI)

Description

Position Objective: Provide services as a Clinical Research Coordinator in support of the overall functions of the National Institute of Neurological Disorders and Stroke (NINDS) within the National Institutes of Health (NIH). The primary role for this Research Coordinator (RC) position is to provide clinical research coordination and protocol navigation for the NINDS Intramural Research Program.

Duties and Responsibilities:

• 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.
• Assist researchers with study testing, observations data entry and other duties associated with study sessions. 5
• Maintains all professional certifications, if applicable.
• Maintain a current clinical trial and clinical research study Good Clinical Practice GCP knowledge base, in order to s erve 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.
• Independently and effectively troubleshoot issues that arise in clinical research setting, by utilizing strong communication and collaboration skills.
• Maintain a line of communication with the Institutional Review Board IRB to keep abreast of new guidance related to protocol and informed consent submissions for initial reviews and amendments.
• Perform accurate and timely data analysis, report results and findings and respond to sponsor queries. Set up, format and enter data into spreadsheets to analyze information and create reports.
• Enter data into research databases, systems and applications for ongoing studies. 4
• Verify study participants information and collect data and results of testing, including verification data for eligibility criteria.
• Assist researchers in collecting, organizing, and maintaining accurate records of all protocols and study applications, investigator qualifications, study logs, safety reports, annual reports, and correspondence.
• Monitor research team training requirements, including maintaining all training records and providing notifications for training renewal deadlines.
• Assist researchers develop, maintain and complete study data collection forms and source documents.
• Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates. Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters,
• agendas, presentations and meeting minutes/summaries.
• Assist researchers design patient Case Report Forms (CRFs).
• Review draft protocols, case report forms, and manuals of operations (MOPs) for clarity, and completeness, as well as provide input to modify them as needed.
• Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.
• Prepare patient charts for clinic days and provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts.
• Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.
• Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests. Assist researchers with the collection and analysis of research data and samples.
• Adheres to applicable Federal, State, and NINDS regulations, policies, and procedures related to clinical research including biospecimen handling shipment.
• Complies with processes and procedures required by different types of sponsors and contractual partners eg private industry, federal agency, and investigator.
• Process, maintain and generate reports from research study data and metadata as needed to assist with study monitoring and data sharing requirements, and recommend preemptive actions as needed.
• Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.
• Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events. Update and maintain logs and records of patient and family contacts.
• Provide continuity of care to patients enrolled on assigned protocols.
• Assesses participants understanding of the information provided during the informed consent process. Assesses ongoing consent through discussions with participants and reinforcement of education.
• Identifies and intervenes to address facilitators and barriers to effective informed consent discussions and decision making eg, literacy, capacity, language, distress, lack of time, therapeutic misconception.
• Obtain or confirm informed consent and or assent completion prior to the beginning of any studies or therapies.
• Assist researchers in tracking and reviewing adverse event files in accordance with Institutional Review Board IRB processes and policies.
• Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• Assist researchers obtain IRB approval before any study related activities begin.
• Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
• Contributes to discussions regarding feasibility of protocol implementation and execution with a specific focus on clinical issues, available resources, study coordination, participant safety, data quality, and recommend operational improvements..
• Provides a redacted copy of the informed consent form for regulatory submission at time of continuing review.
• Assist key research personnel in ensuring that clinical research activities are performed in accordance with all federal, state, and NINDS regulations, policies and procedures related to human subjects' research.
• Assist researchers with developing protocol documentation including schemas, informed consent and assent documents, other regulatory documents.
• Assist researchers in obtaining NINDS approval before any study related activities begin.
• Assist researchers in communicating with IRB, NIH Clinical Center, and other regulatory authorities for protocol approval.
• Maintain content on the Clinical Studies websites (resources for staff and extramural investigators). Assist researchers register studies on
• Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.
• Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms.
• Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.
• Update annual status of recruitment/enrollment in NIH Human Subjects Reporting System.
• 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
• Schedule and participate in monitoring and auditing activities and coordinate responses to audits.
• Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.
• Assess protocols and studies for regulatory compliance, adherence to IRB approvals and Federal standards, such as HIPAA, human subject ethics, privacy, etc. and generate quality assurance reports.
• Assist researchers coordinate, facilitate and prepare site for monitoring visits and FDA audits.
• Documents, collects, records, and retains all research related participant encounters including in person, phone, or electronic in the research record eg source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents.
• Maintains the privacy and confidentiality of participant and research data.
• Anticipates and consistently meets reporting deadlines, collaborating with PIs and teams to note data trends and identify problems.
• Participates in developing recruitment materials with input of investigators and IRB approval for referral sources outlining eligibility information.
• Performs and or coordinates outreach activities, as appropriate to meet research recruitment and enrollment goals. Notes trends in toxicities, participant information, and data collection points.
• Creates and updates protocol operating policies and procedures eg MOPs as needed.
• Identifies and develops relationships with institutional or community-based resources or groups that can assist in achieving recruitment goals.
• Serves as a communication liaison between interdisciplinary team and the research participant.
• Track and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
• Protects participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
• 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
• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). Assist researchers with study testing, observations data entry and other duties associated with study sessions.
• Collaborates with principal investigator and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices, as needed.
• Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities to ensure all aspects of protocol and regulatory requirements are addressed.
• Support storage and maintenance of all study data and metadata on clinical websites (resources for study team personnel and extramural investigators).
• Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.
• Monitor all aspects of reporting to for individual research studies, including keeping track of and providing advance notification to research team of reporting deadlines once study data acquisition has completed.
• Maintain the privacy and confidentiality of participant and research data.
• Protect participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
• Work with investigators to maintain Protocol Applications within the protocol management database system. Instruct clinical and research staff in procedures relative to data management.
• Manages conflicts issues that arise in clinical research setting, by utilizing strong communication and collaboration skills.
• Mentor new HCPS personnel and serve as an expert resource on all aspects of research support.
• Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations.
• Organize, prepare and distribute informational materials and provide support to the educational mission of the study.
• Researches changes and updates to Good Clinical Practices (GCP) and prepares summaries, job aids and training materials for research staff and new clinical research coordinators.
• Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations.
• Mentor new clinical research coordinators on all aspects of research support.
• Performs problems-solving and improves processes as needed to resolve complex and or unpredictable situations.
• 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

Basic Qualifications:

• Bachelor's degree in nursing, community and public health, biology, social work, social psychology, or a related discipline.
• 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).
• Experienced working with Clinical Trial Management System (CTMS), Electronic Medical Records System, and Electronic Data Capture System.
• Demonstrated experience overseeing and documenting IP dispensing, inventory, and reconciliation.
• Experienced closing clinical trial sites down on completion of clinical trial.
• Experience with ordering, tracking, and managing IP and trial materials.
• Experience with the implementation of clinical trial site action plans and training clinical trial site staff.
• Experienced in coordinating project meetings, electronic medical records, protocol review revision, patient confidentiality, remote site monitoring, regulatory compliance, protocol development, clinical research, clinical trials, and protocol writing.
• Experienced in data monitoring, data integrity, patient care, recruitment, scheduling, screening, research, ICH/GCP, and SOPs.
• Experience liaising with regulatory authorities and liaising with ethics committee.
• Experienced with protocol navigation, regulatory affairs, and IRB submissions.
• Previous clinical trials and Phase I or II work experience required.

Minimum Qualifications:

• Ability to multi-task and pay close attention to detail.
• Excellent analytical, organizational and time management skills.
• Strong communication skills, both oral and written.

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job us at . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.