Clinical Research Protocol Manager Jobs (NOW HIRING)

Clinical Research Nursing is the specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. This specialty practice incorporates human subject protection; care coordination and continuity; contribution to clinical science; clinical practice; and study management throughout a variety of professional roles, practice settings, and clinical specialties. Principle duties include coordination and implementation of Phase I- IV clinical trials, coordination and continuity of care for patients enrolled in clinical trials, collaboration among multiple stakeholders involved in the implementation of clinical trials for which they are assigned, and adherence to all applicable guidelines, policies, and procedures related to clinical care and its intersection with the clinical research protocol. The CRN- C has additional responsibilities in the following domains: contribution to clinical science, technology/ informatics, leadership.

Job Responsibilities

Human Subjects Protection

Elicit the research participant's values preferences, expressed needs, knowledge of the healthcare situation, understanding of research protocol requirements, and acceptance of risks versus benefits. Apply ethical, legal, and privacy guidelines and policies to the collection, maintenance, use, and dissemination of data and information. Facilitate initial and ongoing informed consent process.

Care Coordination and Continuity

Coordinate research participant study visits. Facilitate research participant inquiries and concerns. Facilitate education of the interdisciplinary team on study requirements. Collaborate with interdisciplinary team to create a plan of care that allows for safe and effective collection of clinical research data. Provide nursing leadership within the interdisciplinary team. Coordinate interdisciplinary meetings and activities in the context of a study. Coordinate referrals to appropriate interdisciplinary services outside the immediate research team. Communicate the impact of study procedures on the research participants. Provide nursing expertise to community based health care personnel related to study participation.

Contribution to Clinical Science

Ability to review protocol for potential enrollment/ retention issues that may occur regarding logistics of the care delivery system and make recommendations to reduce disruption to protocol compliance and safe patient care. Coordinate development of research protocols and treatment plans with physicians, pharmacists, other nurses, research coordinators, and pharmaceutical companies. Active participation in the development of investigator initiated protocol case report forms and progress notes. Disseminate clinical expertise and best practices related to clinical research through presentations, publications, and/or interactions with nursing colleagues. Serve as an expert in specialty area (ex. Grant reviewer, editorial board, presenter). Participate in query and analysis of research data. Generate practice questions as a result of new study procedure or intervention. Collaborate with interdisciplinary team to develop innovations in care delivery that have potential to improve patient outcomes and data collection. Identify questions appropriate for clinical nursing research as a result of study team participation (ex. Viral shedding studies for gene therapy and implications for nurses administering IP). Mentor junior staff and students participating as members of the research team. Perform secondary data analysis to contribute to the development of new ideas. Serve as a resource to the new investigator.

Clinical Practice

Collects comprehensive data pertinent to the research protocol requirements and the research participant's health and/ or situation. Provide oversight of administration of medications, study drugs, or study interventions, as appropriate. Administer investigational products in approved settings. Staff nurses caring for research patients may not be familiar with the research process- must work alongside the assigned bedside nurse to provide necessary information about the research study including intervention and potential adverse events. Conduct study interventions in accordance with PSOM and health system policies. Provide oversight and coordination of radiographic imaging and laboratory findings. Conduct assessments, collect medical history, and adverse event assessment. Discuss advanced assessment of patient/ family situation as it relates to adverse event attribution defined by the Principal Investigator. Monitor patient care, assess patient status, and monitor treatment side effects. Obtain specimens (including venipuncture) Provide patient and family education and support. Ensure patients are educated regarding the protocol specifics and study drugs. Demonstrate understanding of standard of care activities related to the care of the research participants and requirements of the protocol in which they are enrolled. Demonstrate ability to glean information from multiple sources and integrate that information into clinical practice while maintaining fidelity to the research protocol.

Study Management

Demonstrate knowledge of pathophysiology, pharmacology, and toxicology as related to medicines discovery and development. Coordinate activities of team in caring for patients. Coordinate patient visits and any necessary testing. Maintain Informed Consent for the duration that the patient is participating in the trial. Follow GCP guidelines. Conduct initiation, monitoring, and close-out visits with sponsors and/or CROs. Recruit and screen potential study patients as specified per assigned protocols. Confirm patient eligibility and registration. Complete case report forms (CRFs), and resolve data queries with sponsors and CROs. Obtain records required to complete CRFs. Process and ship biologic specimens (blood, urine, stool, nasal swabs, serum, etc) as directed by the clinical trial protocol. Obtain diagnostic materials such as slides from pathology and/or scans from radiology and ship to sponsor/independent review per protocol guidelines. Attend investigator and site initiation meetings. Adhere to all University of Pennsylvania, ICF, and FDA guidelines. Participate in the conduct of audits by study sponsors, CROs, the FDA, NCI, and Penn Regulatory bodies (OCR, Cancer Center DOCM), and other groups. Prepare and process all regulatory documentation through the Institutional Review Board (IRB) and other entities as required, including amendments, continuing reviews, and adverse event reporting. Prepare and process all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs). Resolve regulatory related queries with IRB, study sponsors, and CRO. Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.

Technology/ Informatics

Utilizes appropriate information and technology to communicate, manage knowledge, mitigate error, and support decision making across the continuum. Searches, retrieves, and manages data needed to make decisions, using information and knowledge management systems. Ability to create clear treatment plans for administration of investigational interventions in collaboration with the pharmacy and IT teams that can be utilized in the Electronic Medical Record by clinical and research personnel. Serve as an expert and champion in the use of technologies that support clinical decisions making, error prevention, and protection of patient privacy. Assists others in retrieving and managing data needed to make decisions, using information and knowledge management systems.

Effectively collaborates and applies innovative, systems thinking to engage in systematic, evidence-based problem solving and decision making to promote effective changes within a complex care delivery system. Exemplifies the ability to build consensus and arrive at a common understanding through effective and skilled communication. Analyzes and interprets the barriers to effective communication within the health care setting and develops strategies to improve outcomes. Effectively engages in the process of cooperation, coordination, and collaboration in an effort to provide for safe, quality outcomes for patients within inter and intra-professional teams, including virtual teams.

Other duties as assigned.

Qualifications

• Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation and 2-3 years of experience required. BSN preferred.
• Two to three years' clinical research experience preferred• Basic Life Support Certification (CPR) required and maintained every 2 years• ACLS preferred and may be required in specific environments (ICU settings, ED, etc)• Applicable Professional Certification preferred (ex. CCRP, CRN-BC, OCN)• Effective problem-solving abilities• Effective communication and writing skills• Ability to multi-task• Demonstrated ability to work as part of a team as well as independently• Knowledge of IRB and human research protection regulations required

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$62,000.00 - $87,561.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
• Retirement