Clinical Research Coordinator

Sarah Cannon Research Institute; Denver (CO); Vor Ort; USD 79.000 - 90.000; Vollzeit

Zusammenfassung

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Clinical Research Coordinator for Blood Cancer and Bone Marrow Transplant (BMT) to run clinical operations, enrollment, regulatory, quality, and site operations. You will support patient enrollment on trials, review designs with physicians, and ensure informed consent compliance.

Responsibilities include data entry, source documentation, adverse event tracking, and coordination of site meetings.

Qualifikationen

• At least one year of oncology experience, preferably hematology/oncology and/or transplant.
• Knowledge of FDA CFR and GCP and clinical research processes.
• Public presentation skills.
• Ability to manage multiple priorities with a diverse team of professionals.
• RN or LPN is preferred.

Aufgaben

• Oversee clinical operations and enrollment for Blood Cancer/BMT trials.
• Review study design and inclusion/exclusion criteria with physicians and patients.
• Ensure informed consent procedures and protocol compliance.
• Collect, enter, and verify data in CRFs or electronic data capture systems.
• Track adverse events, serious adverse events, and protocol deviations.
• Coordinate site meetings, investigator meetings, and communications with monitors and study teams.

Kenntnisse

Oncology experience

GCP familiarity

Regulatory knowledge

Public presentation skills

Data management

Ausbildung

Associate’s Degree

Bachelor’s Degree preferred

Jobbeschreibung

It’s More Than a Career, It’s a Mission.Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.Our MissionPeople who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.As the Clinical Research Coordinator for Blood Cancer and Bone Marrow Transplant (BMT) research you are responsible for overall clinical operations of the facility’s blood cancer research program including enrollment, regulatory, quality, and site operations.You will support enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements.You will review the study design and inclusion/exclusion criteria with physicians and patientsYou will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirementsYou will collect, complete, and enter data into study specific case report forms (CRFs) or electronic data capture systems within study required timelinesYou will ensure the integrity of the data submitted on case report forms or other data collection tools by careful source document review and monitoring data for missing or implausible dataYou will create study specific tools for source documentation when not provided by sponsorYou will generate and track drug shipments, lab kits, and other suppliesYou will be responsible for accurate and complete documentation of protocol requirements according to site work instructions and standard operating procedures (SOPs)You will track and report adverse events, serious adverse events, protocol waivers, and deviationsYou will maintain accurate and complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, screening and enrollment logs, and study communicationsYou will coordinate regular site research meetingsYou will attend study-specific on-site meetings/visits, investigator meetings, conference calls, and other coordinator meetings, as required and you will work closely with monitors, study teams and site staff to ensure quality study dataYou will communicate site status through a weekly activity report to appropriate site/management colleaguesYou should have:An Associate’s Degree, preferably a Bachelor’s DegreeKnowledge of medical and research terminologyKnowledge of FDA Code of Federal Regulations and GCPKnowledge of the clinical research processesPublic presentation skills The ability to manage multiple ongoing priorities and projects with a diverse team of professionalsAt least one year of oncology experience, preferably in hematology/oncology and/or transplantAt least one year of experience in a clinical research settingAt least one year of experience managing blood cancer and/or BMT clinical trials is preferredResearch certification (ACRP or CCRP) is preferredRN or LPN is preferredSalary range $79,000 - $9000About Sarah Cannon Research InstituteSarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.McKesson job postings are posted on our career site: careers.mckesson.com .We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.