• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $75,000 - $85,000

Position Summary

The primary role of this position is to support clinical research involving Maternal Fetal Medicine Research. The employee will interact with women, their families and clinical staff as it relates to clinical research protocols and clinical trials, industry funded and grant funded, being implemented in the outpatient setting.

Responsibilities

• Oversee the day to day operations of the MFM Research Follow-up and NIH Studies.
• Preparation and completion of feasibility surveys.
• Participate and contribute to the grant application process.
• Develop plans for protocol implementation, identify necessary resources and request as appropriate. This includes instruments, equipment and staff.
• Determine recruitment objectives and develop systems to monitor and track achievement.
• Develop all day to day plan and procedures for data collection as well as data confidentiality and data security.
• Responsible for mechanisms and details of protocol adherence and for providing administrative back-up to PI.
• Preparation and submission of annual reports and regulatory information to funding and regulatory agencies.
• Develop local systems & SOPS for secure storage of drugs and supplies and be the point of contact for the research pharmacy
• Preparation of IRB applications.
• Preparation and submission of regulatory documentation to the regulatory bodies as relevant.
• Assist investigators with validation and editing of collected data.
• Participate in Analysis of study data and assist in preparing manuscript.
• Completion of GCP, HIPAA and applicable regulatory training.
• Complete certification requirements for assigned protocols.
• Screen designated schedules or patient lists for eligible subjects, approach and verify eligibility, consent and enroll, when coverage is necessary.
• Complete research study visits as delineated in assigned protocol and manual of operations set forth by sponsor and supervisor.
• Ensure the completion of Telephone follow-up and telephone reminder calls for study participants; during these phone calls the person will need to administer study questionnaire as assigned.
• Coordinate the collection of all research data points as assigned, whether through research visits, chart abstraction or telephone.
• Oversee the scheduling of research visits.
• Collection through venipuncture of biological specimens.
• Processing, transporting and shipping of biological specimens and following of instructions as delineated in the protocol or manual of operations, when needed.
• Completion of study documents and files; some examples might include case report forms, worksheets and medical record notes.
• Maintain confidentiality of documents and files such as HIPAA.
• Informing relevant clinical staff regarding subject protocol participation.
• Regular collaboration with the PI and other research staff.
• Develop and maintain procedures for organizing work and staff; attend investigator meetings as needed.
• Carry out required staff training and provide the direct supervision for assigned staff.
• Assist in other research related activities and projects as needed.
• Maintenance of study documents and files, such as regulatory binders, CVs etc.
• Participate in on-call activities during off-hours.
• Perform other related duties and responsibilities as assigned/requested.

Financial Accountability:

• Oversee proper distribution of funds in accordance with university and all state and federal policies.
• Complete human subject incentive set-up forms.

Decision Making:

• Working under the direct supervision of Senior Clinical Research Manager the Clinical Research Manager has a moderate level of autonomy and is held accountable to the high standards of excellence in clinical research implementation.

Minimum Qualifications

• Requires a bachelor's degree or equivalent in education and experience, plus four years of related experience.
• SOCRA or ACRP certification or in progress within 4 months of hire.
• Phlebotomy Certified (or other forms of certification in lieu of phlebotomy such as certified medical assistant, nursing degree, medical degree) - current or obtained within 3 months.
• Incumbent must be self-directed and able to make independent decision within the parameters of all federal, state, institutional and departmental guidelines.
• Experience in a patient care setting and with clinical research.
• Experience managing people or a project.
• Experience working with data, data entry, data management.
• Complete proficiency in written and verbal English.

Preferred Qualifications

• Knowledge of medical terminology specifically related to Maternal Child Health.
• Master's or another advanced degree may substitute in part for experience.
• Excellent interpersonal, written/oral communication, and organizational skills.
• Proficiency in Microsoft Office.

The Department of Obstetrics and Gynecology is dedicated to the goal of building a multicultural faculty and staff committed to teaching, working and serving in a diverse community, and strongly encourages applications from candidates of traditionally underrepresented backgrounds.

We are continuously seeking to recruit individuals who will enhance the diversity of our workplace and the effectiveness of our organization.