Clinical Research Team Lead

Position Overview

The Team Lead performs multiple and varied clinical study activities actively involved with the management, administration and conduct of clinical research studies for AMR. The Team Lead is responsible for ensuring the complete and accurate performance of all study activities in compliance with federal Food and Drug Administration (FDA) regulations. Team Lead exercises significant authority and responsibility for all site staff. Additionally, this position will participate in the training of all personnel as applicable. Position may require occasional weekend and/or overtime.

To consistently embody AMR’s Core Values:

· Excellence and Consistency

· Collaborative Innovation

· Respect for our Subjects, Sponsors and Team Members

· Community

· Unimpeachable Ethics

The Team Lead reports to the Site Manager and/or General Manager.

Classification: Exempt

Primary Responsibilities:

· Consistently communicates with fellow team members and management staff on needs of the department, workload concerns, etc., and consults with supervisors for assistance and advice as needed.

· Advanced understanding of SOPs and ensure they are adhered to in the conduct of the clinic research study.

· Advanced understanding of all active and upcoming studies.

· Consistently communicate with fellow team members and management staff regarding department, concerns, etc.

· Provide input for the completion of employee evaluations.

· Coordinates and/or trains new staff members in accordance with the training program to ensure staff’s knowledge of and proficiency in applying and complying with standard operation procedures.

· Block CRC schedules as needed for office time, appts, etc.

· Assure study team’s compliance with FDA, ICH and HRA guidelines.

· Identify areas of risk to exposure and report targets to the Site Manager/General Manager along with recommendations for minimizing risk.

· Coordinate with QA team to organize Sponsor and FDA audit preparation.

· Review and update payroll and attendance as needed for designated staff.

· Assist in the interview process of hiring new designated staff.

· Perform staff counseling when necessary.

· Provide quality service to all participants and potential participants in a timely manner; both in person and by phone (directing, assessing and assisting).

· Active participation in CRC meeting/training sessions.

· Track various staff metrics per Site Manager

· Participate in community research events, including local health fairs and other related events.

· Provide coverage for temperature monitoring as needed.

· Other duties as assigned

Additional Responsibilities (Check If Applicable):

Performs random QA reviews to ensure policies, procedures and protocol are being followed appropriately.

Manages oversight of source production to ensure source needs are met for each study.

Routinely meet with CRA during interim monitoring visit.

Review CRA follow-up letters and block CRC time as needed.

Meet with Site Manager regularly to review QA issue or deviation trends.

Monitor schedules daily for overtime needs and recruitment availability.

Assist with Prestudy Visits when requested by Site Manager.

Ensure prescreen lab procedure is followed. Ensure Investigator oversight of these lab results.

Track IATA expiration dates for individual site.

Track credentials and certifications for staff and providers

Meet with recruiters to maintain a sense of urgency to complete study enrollment in the shortest time frame possible.

Work with Investigators and staff on protocols and procedures required for the success and compliance on all research studies.

Ability to administer prescribed treatments according to protocol and/or local regulations.

Serves as a clinical research coordinator for multispecialty clinical research trials.

Desired Skills and Qualifications:

· Successful completion of a formal medical/clinical educational program and possession of a current, unrestricted license or certification (i.e., R.N., L.P.N., C.M.A., E.M.T., R.T.), or in the alternative have a strong desire to learn medical terminology and a demonstrated ability to learn quickly.

· Past experience to include three years of clinical experience involving patient care in a healthcare environment or at least three years of applied clinical research experience.

· Demonstrate interpersonal and leadership skills, including ability to effectively supervise individuals and teams.

· Strong understanding of FDA regulations and ICH guidelines.

· Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances).

· Ability to interpret as needed, clinical, laboratory and diagnostic tests (for the purpose of eligibility review) and ability to perform basic clinical tests as necessary (such as vital signs, height, weight, temperature, etc.).

· Ability to quickly adapt to working in a wide variety of dynamic therapeutic areas of medicine.

· Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.

· Strong written and verbal communication skills.

· Ability to be ambulatory part of the workday.

· Advanced knowledge of computer operations, computer skills, i.e., Word, Excel, Research and Clinic programs.

· Learn and comply with OSHA regulations

· Critical and analytical thinking and mathematical skills.

· Understanding and compliance of Good Clinical Practice Guidelines i.e.: completion of training, testing and application.

· Successful completion of FAA training concerning the handling and shipping of hazardous goods and materials.

· Ability to effectively communicate with Sponsors, CROs, monitors, IRBs, laboratories and clinical personnel.

· Demonstrated ability to exercise standard Universal Precautions; in the alternative, the ability to quickly learn and apply Universal Precautions.

· Demonstrated ability to operate basic office equipment including (but not limited to) copy machines, facsimile machine, multi-line telephones and computers.

· Professional and highly motivated “self-starter” with the ability to exercise initiative. Must have the ability to work as a team leader as well as independently while managing a variety of study related projects simultaneously.

· Advanced knowledge of medications, medical diagnosis and medical terminology.

· Regular and predictable attendance is an essential function.

Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

Job Type: Full-time

Pay: From $62,000.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Shift:

• Day shift

Experience:

• Clinical research: 3 years (Required)
• Leadership: 3 years (Required)

License/Certification:

• IV Certification (Required)

Ability to Relocate:

• Norman, OK 73069: Relocate before starting work (Required)

Work Location: In person

Salary : $62,000