Career

We are starting to make our mark and looking for experienced Clinical Research Coordinator(s) to help us grow and achieve our mission. This is a consulting/contract opportunity. If you have some time and are interested, please read on. This assignment is located in the San Jose, CA area.

We currently have an immediate need for experienced Clinical Research Coordinator(s). This trial is in the area of Neurology, with a focus on Alzheimer’s.

The Clinical Research Coordinators (CRCs) work under the direction of the Adaptive Research Clinical Development Team, reporting to the Project Manager. The CRCs will take a proactive critical role in the initiation, maintenance and close out of clinical studies on behalf of the site. The CRCs work with the site Principal Investigator (PI), existing site staff, Study Sponsor, associated vendors contracted by the Study Sponsor, and central ethics to provide execution of the contracted clinical trial to ensure compliance, quality and meeting the financial and other related aspects of the clinical study.

The position will be responsible for:

• Coordinating with the Principal Investigator (PI), associated department, and central administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and the Study Sponsor policies and procedures.
• Leading the development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• Assisting the PI to ensure that all key personnel and/or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and the Study Sponsor policies and procedures.
• Coordinating and facilitating the monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and Sponsors.
• Respond to any audit findings and implement approved recommendations.
• Cooperating with Study Sponsor agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
• Performing study feasibility assessments as requested.
• Preparing a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.
• Attends investigator meetings and other related meetings as required or requested by the PI.
• Prepare IRB and any other regulatory submission documents as required by the protocol.
• Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study-specific training log.
• Develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Conducts or participates in the informed consent process including interactions with (RB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Collecting data as required by the protocol. Assures timely completion of Case Report Forms.
• Retaining all study records in accordance with study sponsor requirements and community policies and procedures.
• Providing accurate and timely closeout documents to applicable federal agencies, and the study sponsor in accordance with federal regulations study sponsor policies, and procedures.
• Arranging secure storage of study documents that will be maintained according to study sponsor requirements or for the contracted length of time, whichever is longer.
• Performing other related duties as needed.

Education and Experience

• Bachelor’s degree in a related field and a minimum of two (2) years of experience in clinical research/trials, or an equivalent combination of education and relevant experience.
• Prior experience in Neurology and/or Alzheimer’s, preferred.
• Prior experience in the cognitive rating scales.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification, is preferred.

Knowledge, Skills, and Abilities

• Requires excellent communication, organization, analytical and computer skills including proficiency with Microsoft Office 365 and related database applications.
• Prior experience with research protocols and regulatory and/or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Requires a valid California Driver’s License in good standing, along with reliable transportation.

Again, this assignment is located in the San Jose, California area. Local candidates are encouraged to apply.

This is a part-time, contract/consulting opportunity. We are looking for someone who has the flexibility to work weekly on a part-time basis, as needed.

This is a contract role, expected to last 6 to 9 months. We are looking for someone who can commit to a full-time schedule as needed during this period. There is the possibility that this contract arrangement may extend further as we grow.

For immediate consideration, submit your resume/cv to careers@adaptiveresearch.com