Overview

Responsibilities

Qualifications

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Principal Investigator.  The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

Essential Functions

• Participate in the coordination of multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet objectives of assigned research protocol(s).
• Assesses patients for protocol eligibility and communicates findings to Principal Investigator.
• Coordinates the implementation of protocol procedures.
• Assesses and monitors patient responses and adverse reactions; reports same to accountable sources.
• Provides appropriate patient and family education.
• Completes a variety of reports, documents and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes.
• Collaborates with Principal Investigator and study team to ensure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and act as appropriate.
• Assist in the preparation and submission of amendments to clinical trials protocols to the IRB.
• Provides educational in-services as needed.
• Promotes interdepartmental cooperation and coordination for each protocol.
• Maintains reasonably regular, punctual attendance consistent with Headlands Research policy.

Qualifications

• Experience and training in conducting clinical trials with knowledge of ICH GCP
• Bachelor’s degree in a health or scientific related program
• A thorough understanding of regulatory requirements
• 2+ years previous experience working in a clinical setting
• Ability to manage up to 6 clinical trials concurrently
• Excellent written and verbal communication skills
• Ability to interact effectively with professional, administrative staff, sponsor and regulatory representatives, participants and referral sources
• Superior organizational and time management skills
• Bachelor’s degree in a health or scientific related program
• Capable of working independently with minimal supervision and also as part of a team
• Ability to speak a second language is an asset, but not required
• Understanding of medical terminology as well as standard clinical procedures and protocols
• Prior experience training and mentoring staff members is preferred
• Experience with CRIO (Clinical Trial Management System) is a plus

This new Clinical Research Coordinator role is a full-time position and will be based in Orlando, FL

The Company

At Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, our company is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans.

Apply here: https://app.trinethire.com/companies/20192-headlands-research-inc/jobs/47075-clinical-research-coordinator

The Psychometric Rater is responsible for administering and interpreting quantitative and qualitative tests as part of a clinical team investigating pharmaceutical treatments for related disease state which include but are not limited to, Alzheimer’s disease, Mild Cognitive Impairment, Depression, Anxiety, and Parkinson’s Disease. This position is responsible for ensuring that the data collection is in congruence with the philosophy and mission of the company, as well as with the specific scale administration guidelines. The Psychometric Rater follows study-specific protocol guidelines and communicates and interacts with Investigators, clinic staff, sponsoring agencies, and others to effectively perform required testing and related research activities. All duties carried out by the Psychometric Rater are done so in accordance with company policies and SOPs, Good Clinical Practice, as well as all applicable local, state, and federal regulations. Professionals in this role actively participate in outstanding customer service and accept responsibility for developing and maintaining mutually respectful relationships.

PRIMARY RESPONSIBILITIES:

• Conduct cognitive, diagnostic, and clinical assessments of study participants, as well as caregiver interviews for clinical trials under the direction of a supervising Principal Investigator in accordance to FDA, GCP, and protocol guidelines

• Actively work to maintain consistency in the performance of ratings over time for individual subjects to ensure efficacy and prevent rater drift

• Articulate ratings issues to CRO and/or Sponsor, Principal or Sub-Investigator and other members of the study team.

• Maintain accurate, complete, and timely visit source documentation as well as sponsor required information

• Respond promptly to questions and feedback regarding rating assessments

• Ensure subject safety by appropriately assessing and responding to any potential for harm to self or others and reporting it appropriately per company policy

• Facilitate flow of professional and timely communication with subjects, study staff, referral sources, Sponsor and/or CRO, Monitor(s), Auditors and any central ratings groups hired by the Sponsor.

• Complete all study queries in a timely manner

• Conduct telephone screens and pre-screens, as needed

• Administer protocol-specific scales and evaluate results to determine protocol eligibility under the supervision of the Principal Investigator

• Administering and scoring psychometric tests for clinical trial participants in accordance to the visit schedule outlined in the study protocol.

• Maintain compliance with all company policies and procedures.

• Provide appropriate community resource referrals to subjects, caretakers, and family, as appropriate.

• Assist with additional tasks as assigned

Knowledge, Skills, Abilities:

The ideal candidate will demonstrate:

• A genuine interest in the field of cognitive and/or mental health research, and will be able to work in a dynamic office of dedicated professionals.

• Must have the ability to demonstrate situational awareness and empathy while working with patients of diminished mental capacity within the guidelines of research protocols.

• Ability to communicate clearly and effectively (written and oral)

• Excellent interpersonal and customer service skills

• Strong computer skills

• Detail oriented and highly organized

• Maintain reasonably regular, punctual attendance consistent with company policy, the ADA, FMLA, and other federal, state, and local standards

• Strong critical thinking skills

• Strong ability to multi-task

• Ability to support and demonstrate the mission and goals of the company

• Strong time management and organizational skills

Qualifications:

• Master's degree or higher in a field that includes patient assessments, such as psychology or social work

• At least 1-year experience in clinical research or psychometry Preferred

• Experience with cognitive assessments in adults and geriatric populations

• Bachelor's degree will be considered with 1-2 years’ experience in psychometry or a relevant role

• Spanish Speaking preferred

Working conditions:

Travel: 0-10%

Lifting: 0-10 lbs.

Other: Computer work for long periods of time

This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.