Clinical Research Coordinator

Adaptive Research Inc., is driven to disrupt the clinical trial landscape in the United States. We believe that clinical trials should be accessible to all people, and that research should reflect the diversity of all people with certain health conditions. Our network is the key to faster, widely available clinical trials in community practices. We offer on-site CLINICAL RESEARCH personnel, standardized clinical operating procedures, trial management software, and regulatory support. We aim to improve both physician and patient experience while delivering the highest quality of research data efficiently.

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.

CLINICAL RESEARCH COORDINATOR (CRC)

We currently have an immediate need for an experienced Clinical Research Coordinator in the area Neurology, with a focus on Alzheimer's.

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction with the Adaptive Research Clinical Development Team, reporting to the Project Manager. The CRC will take a proactive critical role in the initiation, maintenance and close out of clinical studies on behalf of the site. The CRC works 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, or an equivalent combination of education and relevant experience.
• Requires prior experience in Neurology and/or Alzheimer’s.
• Requires 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.

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 part-time but who also has the flexibility to commit to a full-time schedule as needed.

For immediate consideration, submit your resume/cv .

Job Type: Contract

Pay: $45.00 - $55.00 per hour

Expected hours: No more than 15 per week

Experience level:

• 2 years

Medical specialties:

• Neurology

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Clinical Resarch Coordinator: 2 years (Required)
• Neurology along with Alzheimer's: 1 year (Required)
• research protocol and regulatory/governing body: 1 year (Required)
• Good Clinical Practivces: 1 year (Required)
• cognitive rating scales: 1 year (Required)

License/Certification:

• CRA or Assoc of Clinical Research Professonals certification (Preferred)
• California Driver's License in good standing (Required)

Work Location: In person