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Clinical Research Coordinator

4 months ago

Grand Rapids, United States START Center for Cancer Research Full time
Job DescriptionJob Description

The START Center for Cancer Research (“START”) is the world’s largest global phase I oncology clinical trial research site network. Over its 17-year history, START has provided hope to cancer patients in community practices and hospitals by offering access to cutting edge early phase oncology 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 tested at START facilities 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.

START is needed more now than ever before. There are nearly 20 million new cases of cancer per year across the globe, and 50% of all new clinical trials occur in cancer. Yet, AMCs are saturated with too many trials, too few patients, and not enough capacity to meet the demand. As a result, many of the trials in AMC settings take too long and do not reach patients in need. START offers hope to patients, while allowing clinical researchers to conduct essential trials and biopharma companies the ability to run trials on medicines. START’s legacy is rooted in scientific innovation. As an example, in San Antonio, where START was founded in 2007, START treated the first patient ever with Keytruda – the most effective cancer drug in medical history.

​​​​​​We are hiring for a Clinical Research Coordinator.

Position Summary:
The Clinical Research Coordinator Research Study Coordinator/Study Coordinator is assigned multiple protocols at any time for which they will oversee the aspects of assigned protocols with planning and coordinating patient participation in the trial. They are responsible for implementation as well as completion of protocol specific requirements and will provide accurate, up to date information to all team members involved with any aspect of carrying out protocol specific requirements. They will assist in the maintenance of all study related Case Report Forms, whether paper or electronic as well as know status of completion. They will understand the ethical issues involved in human subjects research, adhering to the Federal Regulations governing research.

Essential Responsibilities:

  • Will be courteous and professional in both written and oral communication, expressing as well as communicating ideas in a non-confrontational manner in one-on-one situations, small groups, larger audiences, email communication, etc...

  • Communicates on a regular basis with Study Sponsor’s, CRO’s, staff, etc. regarding questions, concerns, as well as status of the protocol

  • Will have regular communication with each CRA involved with assigned protocols

  • Will 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

  • Reviews forms created or revised for assigned trials to assure protocol compliance

  • Maintains files using standardized study document labeling and filing procedures

  • Implements initial protocol and amendments, training staff who will be involved in patient treatment and management

  • Maintains an up-to-date contact list

  • Assists with patient screening and determination of eligibility

  • Facilitates the informed consent process ensuring that consent is appropriately completed

  • Prepares and manages source documents according to standard operating procedures

  • Will recognize deviations to the protocol and will work with management and staff to address corrective actions to prevent deviations

  • Will assist CRA with case report form completion and query resolution

  • Will work with the Principal Investigator to complete and submit Serious Adverse Event reports

  • Is responsible for all protocol specific closeout related activities in conjunction with the CRA

  • Will provide documentation for all deviations whether related to the protocol or a SOP

  • Will ensure that all team members involved understand and adhere to assigned protocols

  • Other duties as assigned


Required Skills & Abilities:

  • Demonstrates an ability to work independently in a self-directed environment

  • Effective time management and organizational skills

  • Effective written and verbal communication skills

  • Working knowledge of a variety of health care equipment

  • Ability to make quality, independent decisions

  • Ability to instruct and direct the work of others

  • Able to work effectively and efficiently under tight deadlines, high volumes, and multiple interruptions


Education & Experience:

  • Bachelor’s degree required

  • Minimum of 2 years of patient and/or clinical team member experience, oncology preferred

  • Additional demonstration of clinical research knowledge as evidenced by the use of either CCRP or CCRC credentials is highly desirable


Physical Requirements & Work Environment

  • 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