Clinical Research Manager jobs in Bangor, ME

Northern Light Eastern Maine Medical Center

Department: Cardiology Research

Position is located: Northern Light Cardiology

Work Type: Full Time

Hours Per Week: .9 - 36 Hour/Week

Work Schedule: 7:30 AM to 5:00 PM

Eligible for a Sign on Bonus

Summary :

Through Northern Light Cardiology Research, cutting edge cardiac medical and device therapies are available to the people of our region. The NL Cardiology Research team is dedicated to providing patients with expert services to ensure that all research activity is ethical, safe, and patient-focused, and done in accordance with the Code of Federal Regulations. At Northern Light Health and NL Cardiology, the Clinical Research Nurse will have the opportunity to work with investigators, IRBs and the medical community to implement, execute and maintain clinical studies based upon specific protocols.

Responsibilities :

• Maintains positive working relationships with all members of the healthcare team.
• Supports change within the institution and unit.
• Patient accrual: screens all new patients daily -determines preliminary eligibility- informs physician- follows through with patients for possible entry into clinical trial.
• Collaborates with physicians, nursing staff, pharmacy, accounting to ensure that protocol registration-enrollment procedures are followed: current consent obtained, pre-study tests reported, final eligibility determined, investigational drugs on hand or plan to order; all protocol supplies on hand and appropriate billing is arranged (per Research IDD's and federal guidelines)
• Educates and guides patients and families through the clinical trial consenting process according to the federal regulations and Research IDD's.
• Collaborates with the pharmacist to educate and guide Research staff and inpatient staff about investigational agents and /or investigational administration methods following the federal guidelines and Research IDD;
• Collaborates with healthcare providers to accurately assess patient adverse events using the NIH Common Terminology Criteria for Adverse Events (CTCAE)
• Based on CTCAE assessments, educates and guides healthcare providers in dose modifications and or delays according to the clinical trial guidelines.
• Documents all aspects of patient-staff education - care.
• Develops age specific, individualized plans of care in collaboration with the patient and significant others.
• Provides patients with timely and complete care in accordance with diagnosis, age, and other factors influencing care needs.
• Collaborates with other disciplines on an ongoing basis to effectively manage care as prescribed by the clinical trial.
• Actively participates in Research meetings by providing insights, suggestions, observations and follows up on any requests generated by the meetings.
• Maintains an effective system facilitating completion of clinical trial requirements: appropriate timing of care, minimizing missed required events (ie QOL's ; testing) timely submissions of required data.
• Enrolls only fully eligible patients.
• Promptly reports serious adverse events following the guidelines of each clinical trial, the governing IRB guidelines, and the Northern Light Health IRB
• Completes iCare and has 100% attendance at EMPLOYEE UPDATES
• Participates in routine internal audits reviewing quality issues in care of the research patient and in quality of data management.
• Recognizes, responds to, reports and assists in determining intervention for conditions that require an improvement in performance and/or process.
• Collaborates with Accounting Department to ensure questions regarding clinical trial costs of care are answered.
• Informs Accounting Department when patients who will receive free drug/treatment through the clinical trial are enrolled to ensure that patients are not charged GROWTH.
• Travels to research / investigator meetings and updates staff with pertinent new information

Other Information :

BLS and ACLS required.

Competencies and Skills

• Behaves with Integrity and Builds Trust: Acts consistently in line with the core values, commitments and rules of conduct. Leads by example and tells the truth. Does what they say they will, when and how they say they will, or communicates an alternate plan.
• Cultivates Respect: Treats others fairly, embraces and values differences, and contributes to a culture of diversity, inclusion, empowerment and cooperation.
• Fosters Accountability: Creates and participates in a work environment where people hold themselves and others accountable for processes, results and behaviors. Takes appropriate ownership not only of successes but also mistakes and works to correct them in a timely manner. Demonstrates understanding that we all work as a team and the quality and timeliness of work impacts everyone involved.
• Practices Compassion: Exhibits genuine care for people and is available and ready to help; displays a deep awareness of and strong willingness to relieve the suffering of others.

Credentials

• Required Registered Nurse

Education

• Required High School Diploma/General Educational Development (GED)

Working Conditions

• Need to drive to perform responsible duties.
• Work with computers, typing, reading or writing.
• Prolonged periods of sitting.