JOB DESCRIPTION

Adams Clinical Dallas is dedicated to improving the mental health and quality of life for all humankind. We contribute to the advancement of scientific knowledge by conducting high quality clinical research leading to the future treatments and cures of tomorrow.
We are a small, privately owned business, conducting Phase I-IV clinical research trials throughout the Dallas-Fort Worth metroplex. Our primary focus is on drug development research involving central nervous system (CNS) and mental health disorders.
Conditions we specialize in are: ADHD, Alzheimer’s Disease, Bipolar Disorder, Chemical Dependency, Generalized Anxiety Disorder, Major Depressive Disorder, Obsessive Compulsive Disorder, Schizophrenia, Schizoaffective, Tardive Dyskinesia, and more.
We are currently seeking a highly motivated, organized, analytical individual with exceptional customer service skills and a passion for mental health to fulfill the role of Clinical Research Coordinator.

JOB SUMMARY

Coordinates and administers research study associated activities, under the immediate direction of a principal investigator, following Good Clinical Practice guidelines in an inpatient/outpatient setting. Assists in project planning, develops and maintains recordkeeping systems and procedures, and ensures that pre-established work scope, study protocol, and regulatory requirements are followed. Coordinates research subjects, as appropriate, and serves as principle administrative liaison for the project.

QUALIFICATIONS AND SKILLS

• Strong fluency in verbal and written English communication skills.
• CCRC (ACRP) certification (Highly Preferred) or willing to sit for certification upon eligibility.
• Applicable Bachelor’s Degree (Highly Preferred) or Master’s Degree in applicable clinical fields.
• Understanding of ICH/GCP guidelines for human research (Previous GCP certification preferred).
• Computer competency including proficiency in Microsoft Word and Excel.
• Understanding of Phase I-IV drug development processes.
• Experience in psychiatric/central nervous system clinical trials highly preferred.
• Understanding and knowledge of psychiatric diagnoses and medications.
• ECG, phlebotomy skills, IV infusion, and any other technical skills (if applicable) related to the completion of a study visit as required by the protocol.
• Fulfills the Five C’s of a Good CRC: Coordination, Connection, Commitment, Communication, and Collaboration.

• Plans and coordinates the initiation of research study protocol(s).
• Develops, implements, and utilizes procedures to determine subject eligibility; screens, recruits, and enrolls subjects, ensuring and documenting proper voluntary informed consent; tracks subjects’ information from multiple projects.
• Develops, coordinates, and reviews research study procedures to ensure receipt, completeness, and accuracy of research data required for study protocol.
• Assist in recruitment process for potential subjects. Plays a role in calling, pre-screening, and subject eligibility processes.
• Instructs and coordinates research subjects and/or volunteers, as appropriate to specific study objectives and work scope.
• Ensures the smooth and efficient day-to-day operation of research and data collection activities; acts as the primary administrative point of contact for internal research staff.
• Enter collected data into electronic data capture (EDC) systems in a timely manner (generally 24-72 hours).
• To perform laboratory functions such as vital signs, ECG, blood draw, PK sampling, centrifuge, packing up and shipping out (as necessary)
• Coordinates the day-to-day activities of any technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
• Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
• Attend investigator meeting(s) as necessary required per protocol.
• Maintain contact with sponsors to schedule and coordinate site visits.
• To participate in clinical floor activities on an ongoing basis with research staff to ensure adequate clinical support for trial activities.
• To perform miscellaneous job-related duties as assigned.