Northern Light Eastern Maine Medical Center
Department: Clinical Research
Position is located: Northern Light Eastern Maine Medical Center
Work Type: Full Time
Hours Per Week: 40.00
Work Schedule: 7:30 AM to 4:00 PM
Summary:
The Clinical Research Center at Northern Light Eastern Maine Medical Center assists clinical researchers from various specialties in development, implementation, and finalization of novel projects, sponsored clinical trials, and protocol driven care. Clinical Research Coordinators work closely with the other members of the research team to ensure excellent quality and safety for patients enrolled in clinical trials /projects. Research Coordinators work with healthcare providers, multiple departments and outside facilities to coordinate projects, streamline processes and provide patient coordination support, as well as manage regulatory requirements for research.
Responsibilities:
JOB RESPONSIBILITITES TO INCLUDE, BUT NOT LIMITED TO:

• Maintains research data, participants files, regulatory binders and study databases, and provides initial interpretation. Patient accrual: screens all new patients daily -determines preliminary eligibility- informs physician- follows through with patients for possible entry into clinical trial. Maintain contact with programs/sponsors as necessary.
• 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 CRC IDDs and federal guidelines)
• Develops and implements recruitment/screening strategies. Administers scores and interprets study questionnaires. Educates and guides patients and families through the clinical trial consenting process according to the federal regulations and CRC IDDs.
• Recommends protocol changes and prepares drafts of protocols, research summaries, educational materials and manuscripts. Acts as study resource for patients and family members; being available on call.
• Collaborates with healthcare providers to accurately assess patient adverse events with the sponsors and the IRB.
• Identify problems or obstacles in the system/procedures related to implementation of the study and communicate to the study investigators. Work with the Principal Investigator and Director of Clinical Research to develop study budgets.
• Performs data analysis and QA/QC data checks.
• Conduct or coordinate training for participants, schedule participant appointments, and maintain contact with study participants as necessary.
• Collaborates with the laboratory and other personnel to facilitate the processing and shipment of required laboratory specimens. Seek certification in shipping of laboratory specimens.
• Collaborates with the Lead Clinical Research Coordinator and Director of Clinical Research to develop educational and marketing materials. Act as a resource to other departments.
• Maintains an effective system facilitating completion of clinical trial requirements: appropriate timing of care, minimizing missed required events timely submissions of required data including tracking deadlines for program components.

Other Information:

• Demonstrated excellent oral and written communication skills.
• Strong critical thinking, problem solving and attentiveness to detail.
• Knowledge of anatomy and physiology and medical terminology.
• Ability to prioritize work.
• Experience with Microsoft office (Excel, Access, and Power Point).
• Must have administrative, interpersonal, organizational, and time management skills.
• Ability to follow guidelines, instructions, as well as work independently.
• Ability to communicate effectively and clearly about research.
• Ability to interact effectively with physicians and various other professionals.
• Knowledge of regulations and GCP guidelines relating to clinical research and human subjects' protections.
• Knowledge of IRB processes and procedures.
• Ability to read/interpret written study reports and research data.

Competencies and Skills

• 2 years of relative work experience required. Two years' experience conducting clinical trials or five years' experience with patient care
• 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.

Education

• Required Bachelor's DegreeCertification as a Clinical Research Professional required within 2 years of hire.

Working Conditions

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