Clinical Research Program Manager Jobs in Fort Wayne, IN

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Responsible for various support tasks for the clinical research department. Provides administrative and clerical support to the clinical research team.

Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.

KPA 1 - Maintains working knowledge of research process

• Remains knowledgeable and demonstrates compliance with GCP/ICH guidelines, SOPs and individual protocols
• Attend all study initiation meetings and complete ongoing GCP and protocol-based trainings
• Manages fax and e-mail communications in a timely manner
• Actively seeks clarification to study processes when needed

KPA 2 - Ensures accurate and timely collection and submission of centralized study assessments (radiology, pathology, laboratory, EKG)

• Maintains inventories for all clinical trial supplies, including restock for any study that is actively enrolling or has active patients.
• Facilitates destruction of expired or unused supplies in accordance with site policy and study protocol.
• Prepares supplies needed for patients in advance of scheduled appointments.
• Completes requisitions and shipping of lab samples collected and processed by the clinic
• Supports the collection and submission of central radiology data/images per protocol and study manuals
• Supports the collection and submission of archival tissue Per protocol and study manuals
• Supports the collection and submission of EKG tracings per protocol and study manuals
• Completes Source Documents, Study Documents, Logs, and Master Files to ensure quality, completeness, and accuracy

KPA 3 - Support ongoing clinical trial operations including monitoring and quality audit functions

• Ensures that written and verbal communication with co-workers, sponsors, and other professionals in the pharmaceutical research field are collaborative and courteous
• Maintain, update, and distribute research information and training documents to staff and investigators as instructed
• Reviews monitor follow-up letters and ensure outstanding issues are resolved where applicable
• Prepare and support quality audits and inspections as needed
• Ensure that adequate and accurate records are maintained in the patient medical record and study regulatory file

Education:.

• High school education required
• Some college is preferred

Certifications/Licenses:

• Professional clinical research certification is preferred
• Valid state Driver's License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.

Previous Experience:

• 1-2 years prior research or related medical science experience preferred

Core Capabilities:

• Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.
• Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.
• Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.
• Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.
• Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.
• Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.
• Computer Skills:
  • Proficiency in MS Office Word, Excel, Power Point, and Outlook required.
  • Prior experience with electronic medical records (EMR) is preferred
  • Prior experience with clinical trial data entry systems (EDC) preferred
  • Prior Clinical Trial Management Systems (CTMS) preferred.

Travel: 0%

Standard Core Workdays/Hours: Monday to Friday 8:00 AM - 5:00 PM.

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