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clinical research manager resume example with 9+ years of experience

JC
Jessica Claire
, , 100 Montgomery St. 10th Floor (555) 432-1000, resumesample@example.com
Summary

Multi-talented clinical research professional proficient in handling all aspects of site level clinical trials and compliance procedures. Focused on expanding diversity in clinical trials and compassionate care. Well-organized and hardworking with excellent communication and planning skills.

Skills
  • Clinical Research Experience and leadership
  • Good Clinical Practice
  • Informed Consent Process
  • Trial Oversight
Experience
06/2020 to Current Clinical Research Manager Eden Technologies | White Plains, NY,
  • Recruited, hired, trained, mentored, and led clinical research staff members with focus on GCP and patient/subject care and compassion.
  • Developed and monitored study budgets, contracts, study feasibility and start up including IRB submissions.
  • Ensured all clinical studies are compliant with study protocols and applicable regulations. Served as primary liaison between staff, director, sponsors and regulatory agencies.
  • Managed site initiation, interim maintenance and close out of clinical trials.
  • Promoted the ethical conduct of research by actively participating in research related education meetings.
12/2018 to 06/2020 Clinical Research Coordinator II Drug Information Association Inc | Durham, NH,
  • Identified and recruited eligible study subjects and conducted informed consent process, functioned as primary subject liaison, and maintained all study documents, regulatory binders, source documents and correspondence.
  • Arranged and conducted subject visits for studies per protocol and GCP. Monitored adverse events and reported them as required. Recorded data on source documents, case report forms and electronic web-based systems.
  • Abstracted data from medical records and entered data onto specific case report forms, study source and other required study forms.
  • Maintained inventory of supplies and equipment.
  • Prepared lab kits and requisitions prior to subject visits.
  • Adhered to research protocol compliance with the applicable institutional, local, and federal regulations.
02/2015 to 10/2019 Ophthalmic Technician Ohsu | Scappoose, OR,
  • During my work as an Ophthalmic technician at this large practice I worked for both Ophthalmologists and Optometrists with completing measurements and tests that provided the physicians with the information needed to arrive at a diagnosis and to prescribe treatment.
03/2013 to 09/2015 Optometric Technician The Luxottica Group | Folsom, CA,
  • During my work as an Optometric technician at this small practice, I worked for both Ophthalmologists and Optometrists with completing measurements and tests that provided the doctor with the information needed to arrive at a diagnosis and to prescribe treatment.
  • I served as the department’s superuser for EPIC electronic medical records and handled all prior authorizations for the department
Education and Training
Expected in 12/2022 CATEGORY A, INFECTIOUS SUBSTANCES AFFECTING HUMANS CATEGORY B, BIOLOGICAL SUBSTANCES | IATA, , GPA:
Expected in 12/2022 CERTIFIED PATIENT SERVICE SPECIALIST BSM CONSULTING | , , GPA:
Expected in 12/2022 Ciarc Certified Specular Microscopy Cornea image analysis reading center certified University Hospitals Clevland medical center | , , GPA:
Expected in 12/2022 BIRC digital corneal photographer certified Boston image reading | center, Boston, ma GPA:
Expected in 01/2009 Bachelor of Science; Pending | Psychology Bemidji State University, Bemidji, MN, GPA:
Expected in 05/2003 High School Diploma | Bemidji High School, Bemidji, MN GPA:
Additional Information
Clinical Research Experience

1. A Multi-Center Randomized, Double-Masked, Placebo-Controlled Clinical Trial of suppressive

valacyclovir for One Year in immunocompetent Study Participants with an Episode of Dendriform

Epithelial Keratitis, Stromal Keratitis, Endothelial Keratitis, and/or lritis due to Herpes Zoster

Ophthalmicus (HZO) in the Year Prior to Enrollment.

2. Early Bird: Early Feasibility Study of The Brown Glaucoma Implant in Patients with Severe Visual

Impairment or No Light Perception and Elevated lntraocular Pressure.

3. A Prospective, Concurrent Controlled, Open-Label, Multicenter Observational Clinical Study to Assess

the Long-term Safety of the *** MicroShunt in Subjects with Primary Open Angle Glaucoma

Who Have Completed Participation in the INN-005 Randomized Control Study.

4. A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing

Regimens of Netarsudil Ophthalmic Solution in Patients with Corneal Edema Due to Fuchs Corneal

Dystrophy.

5. A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week, Phase 2 Study to

Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Descemetorhexis in Patients with Corneal Edema Due to Fuchs Corneal Dystrophy

6. A Prospective, Multicenter Study of the OMNI Surgical System in Pseudophakic Eyes with Open

Angle Glaucoma (ORION).

7. A Phase 3, Randomized, Adaptive Dose-Selection, Multi-Regional, Double-Masked, Parallel-Group,

3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects with

Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)

8. A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled trial to Evaluate the Effect

of NOV03 (Perfluorohexyloctane) on Signs and Symptoms of Dry Eye Disease Associated with

Meibomian Gland Dysfunction (Mojave Study)

9. A Prospective, Multicenter Study to Evaluate the Safety and Effectiveness of the Beacon Aqueous

Microshunt for Refractory Glaucoma.

10. A Phase III, Multi-Center, Study to Evaluate the Safety and Efficacy of Epithelium-On Corneal

Collagen Cross-linking in Eyes with Progressive Keratoconus.

11. Field Test of Glaucoma Outcomes Survey.

12. Investigating molecular mechanisms of Ocular disease from Aqueous humor samples.

13. Safety and Effectiveness of the Custom Flex Artificial Iris Prosthesis for the Treatment of Iris Defects.

14. A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of

CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects.

15. Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes on Corneal Transplant Success and Endothelial Cell Loss

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Resume Overview

School Attended

  • IATA
  • center
  • Bemidji State University
  • Bemidji High School

Job Titles Held:

  • Clinical Research Manager
  • Clinical Research Coordinator II
  • Ophthalmic Technician
  • Optometric Technician

Degrees

  • CATEGORY A, INFECTIOUS SUBSTANCES AFFECTING HUMANS CATEGORY B, BIOLOGICAL SUBSTANCES
  • CERTIFIED PATIENT SERVICE SPECIALIST BSM CONSULTING
  • Ciarc Certified Specular Microscopy Cornea image analysis reading center certified University Hospitals Clevland medical center
  • BIRC digital corneal photographer certified Boston image reading
  • Bachelor of Science; Pending
  • High School Diploma

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