Administrative Assistant (Secretary)
PURPOSE AND SCOPE:
Oversees training and issue resolution for facilities, participating in research as well as on-boarding new facilities, PIs and study teams to participate in clinical trials. Acts as a central resource for PIs, study teams and facility staff.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Supports Director Site Support Services in order to complete the administration of business processes and services to ensure the operations effective achievement of goals within the assigned business unit(s).
- Helps clinical research and facility staff adhere to the broad activities of the business unit(s) through the interpretation, application and implementation of company-wide policies and processes appropriate to the functional area(s).
- Supports Director Site Services in the management of clinical research staff including but not limited to: interviewing potential new staff, training of new and existing staff, staff coverage, and team meetings.
- Responsible for growing research business and resources through identification of new study sites and maintenance of existing relationships with investigators, study teams and FKC operations leadership.
- Serves as a resource for clinical research staff by maintaining up to date knowledge of medical terminology FDA regulations, ICH guidelines and Good Clinical Practice.
- Follow processes and operational policies in selecting methods and techniques for obtaining solutions.
- Interacts with internal departments and external customers, particularly in problem resolution.
- Developing study specific and research specific trainings for facility staff.
- Responsible for raising awareness around clinical research within the enterprise through education (teleconferences, WebEx trainings and on-site visits).
- Supports facility staff as clinical research point of contact for issue resolution.
- Responsible for creating study specific and research related training for facility staff.
- Responsible for the project management of investigator initiated trials or other unique trials as assigned.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
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.
- When visiting any type of clinical site or medical center the Manager must follow the facility's standards for Personal Protective Equipment and safety commensurate with the areas visited.
- Frequent travel to investigator sites and occasional travel to company headquarters, dialysis centers, sponsor sites, conferences, meetings, trainings, etc. should be expected.
- Travel 35-40%
- 2 year Associate's Degree required plus 5 years of industry experience with direct access to clinical trial sites and study staff; Bachelor's Degree preferred
- Clinical Research certification from an industry recognized organization (ACRP, CCRA, CCRP, SOCra, etc)
EXPERIENCE AND REQUIRED SKILLS:
- 6+ years' clinical research experience required; CCRC certification preferred.
- Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship. Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
- Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
- Excellent oral and written communication skills.
- Dialysis experience preferred.
- Study coordinator experience preferred.
- A track record of success in a fast paced team environment working under very tight deadlines and ability to meet or exceed deadlines.
- Strong training and problem-solving skills.
- Proficient with PCs and Microsoft Office applications.
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.