The START Center for Cancer Research
Clinical Research Coordinator
The START Center for Cancer Research, Grand Rapids, Michigan, us, 49528
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Clinical Research Coordinator
role at
The START Center for Cancer Research .
The START Center for Cancer Research ("START") is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population – leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many – by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most.
Essential Responsibilities
Communicate on a regular basis with Study Sponsor’s, CRO’s, staff, etc. regarding questions, concerns, as well as status of the protocol.
Monitor the overall day-to-day conduct of assigned studies in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study.
Create/review forms created or revised for assigned trials to assure protocol compliance.
Maintain files using standardized study document labeling and filing procedures.
Implement initial protocol and amendments, training staff who will be involved in patient treatment and management.
Maintain an up-to-date contact list.
Assist with patient screening and determination of eligibility.
Facilitate the informed consent process ensuring that consent is appropriately completed.
Prepare and manage source documents according to standard operating procedures.
Recognize deviations to the protocol and will work with leadership and staff to address corrective actions to prevent deviations.
Assist data coordinator team with case report form completion and query resolution.
Work with the Principal Investigator to complete and submit Serious Adverse Event reports.
Perform protocol specific closeout related activities in conjunction with the data coordinator.
Provide documentation for all deviations whether related to the protocol or a SOP.
Ensure that all team members involved understand and adhere to assigned protocols.
Required Education And Experience
High School Diploma or GED.
2 years of clinical research experience.
Basic understanding of oncology clinical trials, particularly Phase 1 studies.
Strong attention to detail and accuracy in data collection and documentation.
Ability to manage multiple tasks and meet deadlines in a fast-paced environment.
Excellent organizational and time-management skills.
Strong communication skills, both written and verbal.
Ability to interact professionally with patients, study staff, and external stakeholders.
Working knowledge of GCP and regulatory requirements.
Proficient in Microsoft Office Suite and clinical trial management software.
Preferred Education And Experience
Experience working in an oncology setting.
Physical & Travel Requirements
Approximately 80% of time is spent sitting.
Very fast-paced and ever-changing healthcare environment.
Demanding deadlines and time frames.
Constant demand for updating knowledge.
Works closely with physicians and ancillary personnel in caring for and treating oncology/hematology patients.
Benefits and Perks
Comprehensive health coverage: Medical, dental, and vision insurance provided
Robust retirement planning: 401(k) plan available with employer matching
Financial security: Life and disability insurance for added protection
Flexible financial options: Health savings and flexible spending accounts offered
Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.
We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
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Clinical Research Coordinator
role at
The START Center for Cancer Research .
The START Center for Cancer Research ("START") is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population – leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many – by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most.
Essential Responsibilities
Communicate on a regular basis with Study Sponsor’s, CRO’s, staff, etc. regarding questions, concerns, as well as status of the protocol.
Monitor the overall day-to-day conduct of assigned studies in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study.
Create/review forms created or revised for assigned trials to assure protocol compliance.
Maintain files using standardized study document labeling and filing procedures.
Implement initial protocol and amendments, training staff who will be involved in patient treatment and management.
Maintain an up-to-date contact list.
Assist with patient screening and determination of eligibility.
Facilitate the informed consent process ensuring that consent is appropriately completed.
Prepare and manage source documents according to standard operating procedures.
Recognize deviations to the protocol and will work with leadership and staff to address corrective actions to prevent deviations.
Assist data coordinator team with case report form completion and query resolution.
Work with the Principal Investigator to complete and submit Serious Adverse Event reports.
Perform protocol specific closeout related activities in conjunction with the data coordinator.
Provide documentation for all deviations whether related to the protocol or a SOP.
Ensure that all team members involved understand and adhere to assigned protocols.
Required Education And Experience
High School Diploma or GED.
2 years of clinical research experience.
Basic understanding of oncology clinical trials, particularly Phase 1 studies.
Strong attention to detail and accuracy in data collection and documentation.
Ability to manage multiple tasks and meet deadlines in a fast-paced environment.
Excellent organizational and time-management skills.
Strong communication skills, both written and verbal.
Ability to interact professionally with patients, study staff, and external stakeholders.
Working knowledge of GCP and regulatory requirements.
Proficient in Microsoft Office Suite and clinical trial management software.
Preferred Education And Experience
Experience working in an oncology setting.
Physical & Travel Requirements
Approximately 80% of time is spent sitting.
Very fast-paced and ever-changing healthcare environment.
Demanding deadlines and time frames.
Constant demand for updating knowledge.
Works closely with physicians and ancillary personnel in caring for and treating oncology/hematology patients.
Benefits and Perks
Comprehensive health coverage: Medical, dental, and vision insurance provided
Robust retirement planning: 401(k) plan available with employer matching
Financial security: Life and disability insurance for added protection
Flexible financial options: Health savings and flexible spending accounts offered
Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.
We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
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