The research coordinator, RN- III functions with minimal supervision in a clinical research setting and acts as site study coordinator assisting with assessment of the logistical requirements and resources necessary to conduct the research protocol. The research coordinator, RN- III will lead ongoing and protocol activation education and training for the research staff and any participating clinical staff. The research coordinator, RN III will provide assistance with the design and maintenance of organizational processes and tools to aid research operations. The research coordinator, RN- III is responsible for coordinating the conduct of research protocols, assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal, and sponsor regulations and guidelines, BMHCC and BCRI policies and procedures. The research coordinator, RN- III is responsible for patient clinical care and management, recruitment, screening, scheduling, enrollment, submission of data, randomization and patient follow-up. The research coordinator, RN- III is also responsible for specific protocol implementation and management. The research coordinator, RN- III may act as a liaison between the hospital, the IRB, study sponsors, and all investigators. The nurse research coordinators will collaborate with research coordinators, data managers and regulatory specialists. Other duties may be performed as assigned. Travel may be required.Responsibilities
Requirements, Preferences and Experience Education
- Facilitates compliance with the requirements of the research protocol and good clinical practice while remaining cognizant of the needs of diverse patient [email protected]@Identifies the requirements of various types and phases of clinical trials, including objectives, sample sizes, and patient care [email protected]@Identifies sources for and facilitates adherence to current regulations, guidance, and policies that affect research at the institutional, state, federal, and international [email protected]@Complies with the International Air Transport Association and institutional policies for shipping and receiving biological specimens, experimental agents, and [email protected]@Facilitates and participates in the preparation for and implementation of scheduled and unscheduled meetings with external and internal monitors and auditors, including but not limited to the U.S. Food and Drug Administration (FDA), Medicare reviewers, the IRB, and quality [email protected]@Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for experimental devices or drugs as [email protected]@Engage in continuing education of research policies/guidelines. Maintains professional growth and development through seminars, workshops, and professional affiliations to maintain certification/licensure, and keep abreast of latest trends in field of expertise.
- Communicates with research team to facilitate the effective conduct of clinical [email protected]@Provides general clinical research as well as trial-specific information to research, clinical, and other organizational [email protected]@Advocates for clinical trials by participating in community outreach efforts to provide general clinical trials education when opportunities [email protected]@Advocates for the safety and care of clinical trial patients as well as for the promotion and integrity of the clinical [email protected]@Participates in conferences and research initiatives. Participates in Site Initiation Visits (SIV) and external Investigators' [email protected]@As appropriate, attends site disease group tumor board meetings and site disease group collaborative meetings.
- Demonstrates leadership in ensuring patient comprehension and safety during initial and ongoing clinical trial informed consent [email protected]@Ensures the initial and ongoing consent process is performed and documented in compliance with FDA, International Conference [email protected]@Harmonization Good Clinical Practice (GCP), institutional, sponsor, IRB, and other applicable regulations, guidances, and [email protected]@Participates in the education of clinical trial patients about their clinical trial and significant new information that is forthcoming during or after the conduct of the [email protected]@Assess for barriers to effective informed consent discussions and implements plans to overcome [email protected]@Ensures that randomization and registration of patients are performed in compliance with BCC policies, the protocol, ICH-GCP, and federal [email protected]@Adapts to physician schedules to perform protocol specific patient visits and/or procedures including, but not limited to early AM and /or early evening hours as required.
- Manages the activities of patients participating in clinical trials, ensuring compliance with protocol procedures, assessments, and reporting [email protected]@Collaborates with the investigator to ascertain study patient eligibility for a clinical trial patient, including documentation of criteria specified in the [email protected]@In collaboration with the investigator, assesses patients for adverse events and then documents and reports these findings per the protocol and FDA, sponsor, and IRB [email protected]@Utilizes adverse event assessment data and clinical judgement to determine if a dose-limiting toxicity has occurred or if any treatment schedule or drug dose modifications are necessary and communicates findings to the study team and [email protected]@During phase I/dose escalation studies, collaborates with the principal investigator to determine when the maximum tolerated dose has been achieved based on adverse event assessment data and clinical [email protected]@During phase I/dose escalation studies, collaborates with the principal investigator to determine when the maximum tolerated dose has been achieved based on adverse event assessment data and clinical [email protected]@Ensures that protocol lab kits and study specific supplies and dry ice are obtained /ordered as [email protected]@Ensure that the appropriate personnel complete medical intervention as per protocol thought the use of tools to assess completion. Ensure that the orders and collection of protocol specific subject specimens, i.e. pharmacokinetics samples, blood specimen, tissue samples, etc. are obtained as per protocol.
- Ensures collection of source data and completion of documentation that validate the integrity of the conduct of the clinical [email protected]@Complies with regulations, institutional policies, and sponsor requirements governing source data and [email protected]@Demonstrates proficiency in the use of clinical and research-related computer [email protected]@Documents assessment, management, and evaluation in source documents for patients on clinical trials as appropriate to the protocol and [email protected]@Enters data and subject visit milestones into VELOS within 48 hours of the subject [email protected]@Enters data onto case report forms and/or into computer database(s). Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for [email protected]@Ensures study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents. Obtains relevant medical information from patient clinic charts/medical records.
- Enhances recruitment while being mindful of the needs of diverse patient [email protected]@Assists in implementation of recruitment plans to identify and assess individuals who might be eligible for clinical trials, taking into consideration the study entry criteria, required procedures, and other potential factors.
- Enhances adherence to ethical practices during the conduct of clinical trials in order to protect the rights and well-being of patients and the collection of quality [email protected]@Advocates for ethical care of clinical trial patients and the conduct of clinical trials in accordance with standards of nursing [email protected]@Identifies and follows institutional procedures to report any falsification of data or scientific misconduct
- Identifies financial variables that affect research and supports good financial stewardship in clinical [email protected]@Identifies routine care versus research-related costs, the financial impact on patients, and any need for financial [email protected]@Updates Budget/Financial staff as requested about patient accruals/completed cycles for billing of Industry Studies and for in-house studies.
- Identifies his or her ongoing professional development needs and seeks resources and opportunities to meet those needs, such as memberships in nursing, oncology, or research [email protected]@Participates in educational opportunities to increase knowledge about clinical trials, regulations, and [email protected]@Maintains certification in specialty [email protected]@Seeks resources on an ongoing basis that provide oncology treatment and nursing practice updates, such as through professional mentoring and meetings, journals, and Web sites.
- Completes assigned [email protected]@Achieves all requirements for assigned [email protected]@Completes all assigned goals within designated time frames
Preferred: Master's Degree in Nursing
Minimum: Bachelor's Degree in Nursing or equivalentExperience
Preferred: 5 Years Experience in Oncology and/or Clinical Research
Minimum: 5 years Research or Clinical Research Experience Licensure, Registration, Certification
Minimum: BLS AHA, RNSpecial Skills
Preferred: Computer skills to include MS Word Excellent Organizational skills. Detailed Oriented; Experience With EMR and Clinical Trial Management SystemTraining
Minimum: Certification required SOCRA (Society of Clinical Research Associates), ACRT (Association of Clinical Research Professionals)About Baptist Memorial Health Care
At Baptist, we owe our success to our colleagues, who have both technical expertise and a compassionate attitude. Every day they carry out Christ's three-fold ministry-healing, preaching and teaching. And, we reward their efforts with compensation and benefits packages that are highly competitive in the Mid-South health care community. For two consecutive years, Baptist has won a Best in Benefits award for offering the best benefit plans compared with their peer groups. Winners are chosen based on plan designs, premiums and the results of a Benefits Benchmarking Survey.At Baptist, We Offer:
- Competitive salaries
- Paid vacation/time off
- Continuing education opportunities
- Generous retirement plan
- Health insurance, including dental and vision
- Sick leave
- Service awards
- Free parking
- Short-term disability
- Life insurance
- Health care and dependent care spending accounts
- Education assistance/continuing education
- Employee referral program
Position: 17334 - Coordinator-Research Nurse III RN
Facility: BMHCC Corporate Office
Department: BCRI Baptist Clinical Research
Category: Nurse RN
Type: Clinical Nurse
Work Type: Full Time
Work Schedule: Days
Located in the Memphis metro area