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Fresenius Medical Care North America Clinical Project Associate (REMOTE) in Waltham, Massachusetts

PURPOSE AND SCOPE:

Supports Clinical Innovations team by working under the supervision of team members and other site personnel as applicable. Performs administrative assistant duties for team members and conceptually applies the research or project protocol to the clinical setting to allow for accurate and timely completion of all duties assigned. Maintains appropriate documentation associated with the assigned clinical study or project. Ensures studies and projects are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), ICH, and FDA guidelines. Applies project management principles to all projects.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines.

  • Under the supervision of immediately Supervisor, assists in preparation and submits regulatory documents in an accurate and timely manner.

  • In collaboration with immediate Supervisor, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria

  • Responsible for working with Clinical management, including RN's to completely understand the clinical needs of the patients as it applies to the study or project.

  • Communicates with the team members and other clinical staff members regarding minutes of meetings that would include clinical conversations and terminology, knowledge or work needed, assisting with site training, maintenance of pilot site recruitment records, management of clinical data spreadsheets, contributes clinical knowledge in brainstorming sessions, and takes a leadership role if a project is involved with nutrition. Maintains data records and reporting requirements; audits data and follows processes for data correction as indicated.

  • Performs administrative duties such as data entry, scheduling meetings and conference rooms, create meeting documents and food arrangements, preparation of documents, office management tasks, liaison to other office personnel, and ordering of office supplies.

  • Responsible for maintaining the accuracy and filing of all documentation.

  • Obtains informed consent forms under direct or indirect supervision

  • Works with clinicians to support implementation of project or research intervention.

  • Schedules subject visits.

  • Completes case report forms in a timely manner.

  • Educates the subject about the applicable study particulars.

  • Informs/updates the subject about pertinent study details as needed.

  • Meets with the study monitor to review, verify and correct all data entered onto the case report form and to ensure appropriate maintenance of study records.

  • Reports subject's progress, complaints and issues immediate Supervisor.

  • Collects pre-study essential documentsssential to protocolRB as neededccording tot he and files appropriately in the study record.

  • Maintains subject participant records.

  • Provides a list of all study participants to facility/practice management to avoid improper billing of lab tests or services covered under the research budget.

  • Ensures appropriate storage, access, and maintenance of records.

  • Documents investigational products received dispensed, and returned to study sponsors.

  • Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner

  • Attends Investigator Meetings as necessary.

  • Assist with various projects as assigned.

  • Other duties as assigned.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Day to day work includes desk and personal computer work and interaction with patients, facility staff and physicians.

  • The work environment is typically an office setting, with potential site visits to dialysis clinics or health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials.

  • 10-15% travel between assigned facilities and various locations within the community required. Travel to regional, Business Unit and Corporate meetings may be required.

EDUCATION:

Bachelor's Degree preferred.

EXPERIENCE AND REQUIRED SKILLS:

  • 2 to 5 years of healthcare experience with Dialysis experience preferred.

  • Research experience preferred.

  • Current appropriate state licensure if applicable.

  • Good computer skills - Microsoft Office (Word and Excel.)

  • Good communication and organizational skills.

  • Ability to work independently.

  • Attention to detail

  • Strong administrative skills.

  • Ability to handle multiple tasks simultaneously.

  • Ability to work under deadlines.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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