Clinical Research Coordinator Associate
The Suicide Prevention Research Lab within the Department of Psychiatry and Behavioral Sciences is seeking a Clinical Research Coordinator Associate to serve as a project manager and study coordinator of clinical research studies focused on sleep, mental health, and emotion. The mission of our program centers on the identification of novel therapeutic targets for suicide prevention and mood disorders, particularly those aiming to reduce stigma and enhance access to care. This work utilizes cognitive, biologic (e.g., fMRI), and behavioral testing paradigms, with an emphasis on translational therapeutics. Clinical trials underway involve testing of a non-pharmacological insomnia treatment to improve mood and overall well-being. A specific focus of this work emphasizes use of rapid-action, low-risk treatment approaches. Our aim is to delineate transdiagnostic risk factors and biomarkers of clinical response that may inform treatment innovation. An overarching mission is to harness new technologies within suicide prevention, including artificial intelligence (AI) and mobile health applications, to enhance triage and intervention opportunity.
Main duties include in-person and telephone recruitment of research participants; obtaining informed consent; scheduling and coordination of research participant clinical study visits; maintaining longitudinal contact with participants by phone, email and other means; psychological assessment data collection/scoring/entry.
In addition to submitting your resume/CV, please include a cover letter describing your prior experience with research. For more information, please see the following laboratory website:
- Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
- Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
* - Other duties may also be assigned
- Coordinate collection of study specimens and processing.
- Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
- Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
- Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
- Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- Participate in monitor visits and regulatory audits.
- Plan and perform research tasks of limited complexity requiring initiative and judgment in applying basic knowledge and understanding of scientific theory when precedents do not provide specific guidance; general instruction is provided by the supervisor.
- Administer questionnaires and rating scales requiring judgment in applying non-routine scoring procedures.
- Excellent verbal and written communication skills.
- Bachelor’s degree in related field
- Ability to work independently and proactively, with good organizational skills.
- 2+ years of related experience in subject recruitment, assessment, and analysis related to clinical research in psychiatry or a related field.
- Proficiency with statistical software (eg, SPSS or R) preferred.
- Ability to work under deadlines with general guidance.
- Desired experience with software packages for survey development and administration (eg, Qualtrics and RedCap)
- Knowledge and past coordination and data entry experience with clinical research studies desired; experience and exposure to study conduct within psychiatry and clinical trials preferred.
EDUCATION & EXPERIENCE (REQUIRED):
- Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Strong interpersonal skills.
- A high attention to detail.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
CERTIFICATIONS & LICENSES:
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
- • Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
- • Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
- * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
- Schedule: Full-time
- Job Code: 4924
- Employee Status: Regular
- Grade: F