The Peripheral Neuropathy Team within the Department of Neurology is looking for an experienced Clinical Research Project Manager. This individual will provide overall direction and day to day management over several neuropathy projects. This position will mentor other clinical research coordinators, research associates, temporary employees, and students.
Project Leadership and Staff Oversight
In collaboration with the PI, lead and execute project vision.
Communicate with study team and PI concerning progress of research, subject related problems, recruitment strategies, and specific policies and procedures.
Review and manage billing charges and discussed projected budget.
Manage procurement of study related materials and supplies.
Functional supervision of the Neuropathy team comprised of Clinical Research Coordinators, Clinical Subject Coordinators, Research Assistants, and students.
Participate in hiring and provide feedback for evaluation process with the PI.
Oversee onboarding and training of staff members. Provides guidance and mentorship to study team personnel.
Research Activities and Process
Possess a working knowledge of clinical trial design and conduct.
Participate in research treatment plan by reviewing the overall structure, and requirements for each protocol with principal investigator, or designee.
Assist with the development of study specific source documents.
Assist the principal investigator with preparation, finalization, and submission of IRB protocol.
Assist the principal investigator with setting up contracts, financial agreements, coordination of ancillary services (i.e. MCRU, Investigation Drug Service).
Obtain informed consents for participation in clinical trials.
Support collaborators and lab staff with current and future projects.
Execute study visits and study related procedures.
Assist with the development of appropriate resource documents, patient diaries, and teaching tools.
Review the study design and study procedures prior to implementation of protocol treatment as appropriate.
Reinforce all study treatment related patient education.
Perform study-specific testing on study subjects.
Perform other duties as assigned or required for the research project.
Provide cross coverage for other ongoing research projects, as needed.
Maintain communication regarding protocol specific information and research orders with Research investigators.
Actively protect and assure the safety of patients on research protocols.
Document and report all adverse events as appropriate.
Participate in audits as well as monitor visits (as needed) with outside agencies and University of Michigan according to policy.
Organizational management, including but not limited to, timeliness in completing source documentation, reporting adverse drug experiences, managing workload, and managing patient study files.
Obtain patient self-administered forms, including study specific questionnaires and patient medication diaries.
Schedule, prepare and attend DSMB meetings and record minutes.
Manage and clean study data.
Communication and Respect
Demonstrate the ability to collaborate with other team members.
Maintain a highly professional and positive attitude regardless of workload and stress level.
Input, retrieve and interpret data from multiple sources.
Respond to communications from patients and colleagues.
Exhibit professional verbal and non-verbal communication skills.
Demonstrate ability to work with computers and general computer programs (Excel, word, access, etc).
Professional Leadership and Teamwork
Utilize time in an efficient manner by completing assigned duties.
Participate in meeting the educational needs of self and others.
Complete all other clinical and administrative tasks as assigned.
Implement change to achieve identified team goals.
Seek opportunities to meet individual objectives identified in the Professional Development Model.
Use organizational skills to assist the study team in providing safe and efficient care to the patient.
Use organizational skills to assure continuity of care in collaboration with other disciplines through appropriate planning, education, and coordination of services.
Collaborates with medical staff to facilitate and optimize the care of the research patient.
Master's degree or Bachelor’s degree with additional related experience in clinical research above minimum.
Professional certification through ACRP (CCRC) or SOCRA (CCRP) or willingness to get certified.
6+ years direct related experience.
3+ years as a CRC- Associate (or equivalent) or above.
Registered Nurse preferred.
Outstanding teamwork and communication skills.
Excellent time management and organizational skills.
Exceptional ability in handling multiple tasks.
Exceptional critical thinking skills in daily practice; assessment, planning, intervention and evaluation.
Demonstrated ability to collaborate with multi-disciplinary team, prioritize duties, multi-task and problem solve with minimal supervision as measured by interview, references and performance evaluations.
Demonstrated accountability to departmental requirements.
Ability to work independently with minimal supervision.
Understanding of medical terminology.
Knowledge of University policies and procedures.
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