Fda Researcher Jobs (NOW HIRING)

Department:
38923 Wake Forest University Health Sciences - Gerontology
Status:
Full time
Benefits Eligible:
Yes
Hours Per Week:
40
Schedule Details/Additional Information:
Full-time, 8-5 M-F
Pay Range
$21.85 - $32.80
JOB SUMMARY
Schedules and verifies patient appointments. Answers telephone calls, prepares and packs laboratory samples to be shipped. Completes reports and maintains research correspondence and enrollment logs. Key responsibilities of this position include maintaining and updating records for the brain donation study, processing invoices, managing supply requests, and supporting the administrative core of the P30. These tasks require a high degree of accuracy, consistency, and organization, as they directly contribute to regulatory compliance, financial stewardship, and effective study management. This position is a shared role that will provide essential administrative and operational support to the Alzheimer's Disease Research Center. Responsibilities will span both the Administrative (25%) and Clinical Cores (75%). Key functions will include managing communications, coordinating events and meetings, supporting financial and vendor processes, maintaining documentation for grants and reporting, and assisting with travel, reimbursements, and regulatory tasks. Success in this role requires strong organizational skills, attention to detail, proficiency with Microsoft 365 and enterprise systems, excellent written communication, and the ability to manage multiple tasks in a fast-paced clinical research environment.
EDUCATION/EXPERIENCE
Two years' experience in a research setting. Associate's degree preferred.
ESSENTIAL FUNCTIONS
1. Assists with preparation and submission of applications, updates and other documents to local and central IRBs (Institutional Review Boards).
2. Submits documents to sponsors as requested by Investigators, supervisor and Clinical Research Coordinators.
3. Prepares source document packets with attention to detail as requested by Clinical Research Coordinators. Maintains an organized and accurate filing system. Assists with storage preparation of closed studies.
4. Enters data into sponsor specific EDC systems for multiple clinical trials. May also assist with data entry on paper CRFs as requested by Clinical Research Coordinators.
5. Extracts patient information from electronic medical records and/or paper medical records for submission to Clinical Research Coordinators as requested.
6. Contacts potential/current research participants regarding appointments, clinical trial opportunities, etc. as requested by Clinical Research Coordinators.
7. Prepares for and participates in monitoring visits, sponsor and FDA audits as assigned by supervisor.
8. Collaborates with outside facilities to obtain medical records and patients referrals.
9. Distributes incoming mail/packages, prepares and coordinates mailings and shipments as requested. Assists with putting away of shipments as requested by Clinical Research Coordinators.
10. Answers phones, record messages, and direct calls appropriately and professionally. Submits enrollment and other logs to sponsors on designated days. Maintains site master files for all studies-includes filing correspondences, updating CVs, licenses, etc.
11. Greets and checks-in patients. Assists with scheduling and entering appointments.
12. Maintains and orders adequate office supplies. Assures patient restrooms, snack and waiting areas are clean and properly stocked with needed items. Records room, refrigerator and freezer temperatures onto logs.
13. Attends relevant professional meetings.
14. Performs other tasks as delegated by supervisor and/or Investigators.
SKILLS/QUALIFICATIONS
Knowledge of English grammar, spelling and punctuation
Knowledge of wide variety of disease processes and medications
Knowledge of phlebotomy and the handling of specimens
Knowledge of computer systems and applications specifically
Excel software
Knowledge of common safety hazards and universal precautions to establish a safe work environment
Knowledge of organizational policies, procedures and protocols
Knowledge of GCP guidelines
Knowledge of FDA Research Regulations
WORK ENVIRONMENT
Combination of medical office and exam/procedure room settings
Well-lighted, well-ventilated, and adequate space
Frequent exposure to diseases, medicinal preparations and other conditions common to a clinic environment
Our Commitment to You:
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including:
Compensation

• Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
• Premium pay such as shift, on call, and more based on a teammate's job
• Incentive pay for select positions
• Opportunity for annual increases based on performance

Benefits and more

• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program

Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.
About Advocate Health
Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.