Contract- Assistant Clinical Research Coordinator (Farmington, MI)*

Profound Research:

Profound Research seeks to drive clinical innovation by partnering with community physicians to offer clinical research as a therapeutic option to their patients. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to grow its energetic team inspired by changing how patients and providers engage in clinical research.   

Our Mission: Improving Lives by Providing Advanced Therapeutic Options 

Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research 

Our Values: 

Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. 

Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues.  

Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. 

Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards.  

Profound Ethos

o Physicians are the Vanguard   

o All Decisions Improve Patient Care   

o Never Compromise Quality   

Why this Role Exists

The Assistant Clinical Research Coordinator at Profound Research supports the coordination and execution of clinical trials by assisting with patient recruitment, data collection, and regulatory compliance. This role ensures adherence to study protocols and patient safety, providing essential administrative support to maintain high research standards and contribute to the success of clinical studies.

Responsibilities

·       Works under the direction of the clinical research site management, Principal Investigator, and other more senior clinical research staff

·       Participate in active patient recruitment efforts

·       Supports the lead clinical research coordinator and other clinical research staff with daily clinical trial activities which may include phlebotomy,  laboratory, data entry, and administration assignments.

·       Conduct all assigned clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws,  regulations, policies, and procedural requirements.

·       Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner.

·       Coordinate, with supervision, duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up.

·       Apply good documentation practices when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. 

·       Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.

·       Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products.

·       Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.

·       Other duties as assigned.

Requirements

·       Bachelor’s degree with 1 year of relevant experience in the life science industry OR

·       Associate’s degree with 2 years of relevant experience in the life science industry OR

·       High School Graduate and/or technical degree with minimum of 3 years relevant experience in the life science industry

·       Demonstrated knowledge of medical terminology

·       Demonstrated ability to use the following technology Computers, Microsoft Office software, fax, copier, and multi-line telephone.

·       Demonstrated ability to work in a fast-paced environment.

·       Experience performing some clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens.

·       Excellent attention to detail, organization, and communication with varied stakeholders.

Travel Requirements

·       Daily commute to site location

Physical Requirements 

·       Prolonged periods of sitting at a desk and working on a computer, standing and walking. 

·     Must be able to lift 25 pounds at times. 

·     Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. 

·     Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. 

·     Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. 

·     The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.