Summary
Overview
Work History
Education
Skills
Vendor Experience
Experience in Clinical Studies
Location and Date:
Timeline
BusinessDevelopmentManager
Anjela Akinyi Agala

Anjela Akinyi Agala

Clinical Research Coordinator
Heidelberg

Summary

ABOUT ME:

Clinical Research Management Graduate with a solid theoretical knowledge of clinical research regulations, Project Management, data management, study design and trial conduct. Strong Background in Oncology and Geriatry. Proven track record in enhancing patient recruitment and supporting Compassionate Use Programs. Process-oriented professional, dedicated to advancing research and improving patient outcomes.

Overview

11
11
years of professional experience
3
3
Languages

Work History

Clinical Research Coordinator

National Center for Tumor Diseases (NCT) /German Cancer Research Center (DKFZ)
04.2024 - Current
  • Follows clinical research protocols and conducts study visits in compliance with ICH/GCP.
  • Coordinates of Phase I–IV Mamma carcinoma ISTs and IITs from site selection through initiation till study close out.
  • Assesses patients' eligibility criteria following strict adherence to inclusion/exclusion criteria.
  • Trains new team members on essential clinical trial protocols and procedures, promoting a culture of continuous learning.
  • Manages patient recruitment, informed consent process and data entry to support trial objectives.
  • Management of patient visits, AE/SAE reporting, and eCRF data entry.
  • Collects blood samples, prepares samples according to the study protocol and organizes shipment to local and central laboratory according to IATA Dangerous Goods Regulations
  • Coordinates vendor-related trial activities (e.g., LabCorp, Q² Solutions, Cellcarta, FMI) including sample shipment, tracking, and documentation
  • Coordinates imaging appointments (CT, MRI, bone scan) and multidisciplinary consultations e.g Ophthalmology, Cardiology.
  • Prepares and maintains regulatory documents for clinical trial submissions.
  • Facilitates clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
  • Retrieves and documents Investigator’s Brochures, study updates, safety letters, and newsletters from vendor and sponsor platforms.
  • Participates in initiation visits and investigator meetings, implementing trials following study timelines and budgets

Accomplishments:

  • Supported the setup and coordination of Compassionate Use Programs (CUPs) for Inavolisib (Roche) and Mirvetuximab(Abbvie)
  • Developed source data worksheets

Nurse-Oncology and Rheumatology Department

St. Vincentius Hospital
01.2019 - 03.2024
  • Supported oncology patients with various diagnoses(e.g. Osteosarcoma, Chondrosarcoma, Lymphoma, Leukemia, CUP, Rheuma e.t.c )during chemotherapy and other treatments
  • Administered medications p.o and IVs while monitoring responses in accordance with physician orders.
  • Monitored vital signs, performed blood collection, and maintained documentation.
  • Assisted physicians with coordination of imaging/staging and stem cell transplant appointments.
  • Prepared, connected, and supervised chemotherapy infusions, including operation and monitoring of infusion pumps.
  • Ordered and managed medications, infusion materials and other nursing materials from the pharmacy and medical supply stores.
  • Educated patients on disease management, self-care techniques, and wellness strategies to improve long-term health outcomes.
  • Responsible for patient admission and discharge procedures.

Geriatric Nurse

Agaplesion Maria Von Graimberg
10.2014 - 12.2018


  • Provided comprehensive nursing care for elderly patients, including personal hygiene, wound care, and medication administration.
  • Monitored and documented vital signs, mobility, nutrition, and overall wellbeing.
  • Assisted with admission and discharge documentation and coordinated patient information with physicians and family members.
  • Collaborated with the MDK (Medical Service of Health Insurance) during quality audits and nursing-grade assessments.
  • Ensured infection prevention and hygiene compliance according to institutional policies.
  • Supported residents in maintaining daily routines and encouraged independence and mobility.

Education

Bachelor of Science - Clinical Research Management

University of Applied Sciences
Bochum, Germany
10.2025

Study Nurse GCP Training

GCP Service International
11.2023

Certificate - Nursing

Academy For Health Professions(AfG) , University Clinic
Heidelberg
09.2014

Skills

SOPs understanding

Vendor Experience

Imedidata , IQVIA, Labcorp, IQVIA Q2 Solutions, Almac, FMI, Cell Carta, Signant Health, Veeva Vault, SIP, Perceptive, Endpoint, 4G

Experience in Clinical Studies

  • Gilead: Ascent 07-GS-US-598-6168, Phase 3, randomized, Sacituzumab Govitecan versus TPC in patients with HR pos. HER 2 neg advanced, inoperable or metastatic Breast Cancer, since 05/2024
  • IFG Erlangen: Captor BC -open label phase IV study investigating the combination of ribociclib and standard of care endocrine treatment for the discovery and validation of molecular and non-molecular biomarkers predicting drug response and resistance, since 05/2024
  • Roche: HeredERA WO43571- Phase 3, open label, randomized, Giredestrant with Phesgo versus Phesgo after induction therapy in untreated HER2 pos, ER pos, advanced metastatic BC, since 05/2024
  • Roche: PionERA C044657- Phase III, Randomized Open-Label Study, Evaluating Efficacy and Safety of Giredestrant compared with Fulvestrant both Combined with CDK4/6 Inhibitor in Patients with Estrogen Receptor-Positive HER2-Negative Advanced Breast Cancer with Resistance to adjuvant ET, since 06/2024
  • Astra-Zeneca: Evopar BR-01 D9722C00001- Randomised Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared with Physician Choice of CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line treatment of Patients With BRCA1, BRCA2 or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative, Advanced Breast Cancer since 05/2025
  • Roche: INAVO 123 (WO45654) phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Inavolisib plus CDK4/6 inhibitor and Letrozole in patients with endocrine-sensitive PIK3CA mutated, hormone receptor positive, HER-2 Negative advanced breast cancer, since 04/ 2025
  • Pfizer: C5731004/SGNDV004- Phase Ib/2 Open-Label Study of Disitamab Vedotin in Combination with Other Anticancer Therapies in Solid Tumors, since 07/2025
  • BMS: IZABRIGHT Breast -01 CA244-0008-A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs Since 08/2025
  • Novartis: CECI830A12101- A Phase I Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer, Since 10/2025

Location and Date:

Heidelberg, 03.JAN.2026

Timeline

Clinical Research Coordinator

National Center for Tumor Diseases (NCT) /German Cancer Research Center (DKFZ)
04.2024 - Current

Nurse-Oncology and Rheumatology Department

St. Vincentius Hospital
01.2019 - 03.2024

Geriatric Nurse

Agaplesion Maria Von Graimberg
10.2014 - 12.2018

Bachelor of Science - Clinical Research Management

University of Applied Sciences

Study Nurse GCP Training

GCP Service International

Certificate - Nursing

Academy For Health Professions(AfG) , University Clinic
Anjela Akinyi AgalaClinical Research Coordinator