Notice: MCRA’s Talent Solutions division works to untie top talent with opportunities on our clients’ teams.
This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.
Our client seeking a contract/temporary, part-time clinical research coordinator to support ongoing studies for one of our medical device clients. This position will be based in-person at a study site/clinic and will support all trial activities at the site level. The Contract Study Coordinator will be responsible for liaising with Sponsor and CRO as necessary, collecting, assessing, and coding subject study data, responding to queries, managing the study budget, and other duties as needed. This Coordinator will also provide support by assisting or leading site recruitment, screening, and enrollment (i.e., consenting participants, administering questionnaires, participant monitoring, etc.), adhering to research regulatory and ethical standards (completing required training, maintaining the ISF, IP inventory, etc.), and other duties as assigned. This position is part-time and temporary – roughly ~20 hours per week.
The duration of assignment is 6 to 8 months.
Position Responsibilities:
- Provide on the ground support to clinical trial activities at the site level under the guidance of the PI at the site and CRO/Sponsor partner.
- Implement and coordinate research and administrative procedures for the successful management of clinical trials.
- Perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols
- Enters study and/or research participant data into the Clinical Trial Management System (CTMS) or other record keeping systems as applicable
- Informed consent – explain the informed consent process and the study to the research participant (e.g., purpose, duration, risks/benefits) and obtains all required signatures; ensures the research participant has sufficient time and opportunity to ask the investigator medical questions; documents the informed consent process in the source document and provides the research participant with a copy of the informed consent
- Participant recruitment – recruits research participants and discuss study protocol; educates research participants about protocol expectations and meets with research participants for each visit and maintains accessibility to discuss any questions or concerns regarding the study; oversees the development of advertising materials; participates in teleconferences and/or meetings to review study progress and conduct
- Data entry responsibilities include the completion and maintenance of case report forms and reviews data against the research participant's medical record for completeness and accuracy
- Study conduct responsibilities include research participant interviews and assessments at study visits as required by protocol; assessing and ensuring research participant safety through study participation; maintaining close communication with investigator; attending investigator meetings as appropriate and communicating relevant information to the research team (including sponsor and CRO as needed); understanding and proficiently communicating all components of research documents, such as protocol, investigator brochure and research instructions
- Additional duties as assigned
- Ensure all work products comply fully with related guidelines, regulations, standards, policies, and mission of MCRA.
Required Qualifications:
- Education: Associate’s degree required; Bachelor’s degree preferred.
- Certification/Licensure: CCRC certification is preferred but not required.
- Experience: 2+ years of relevant clinical research experience required.
- Strong attention to detail and the ability to work both individually and collaboratively within a fast-paced clinic environment, as well as with external partners.
- Possesses strong written and verbal communication and presentation skills.
- Ability to comprehend technical medical language and dissect clinical research protocols.
- Strong research, analytical and problem-solving skills.
- Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
- PC/Technical skills- MS Office, Excel, Word, and various web applications.
- Strong professionalism and customer service skills.
- Effective interpersonal skills
Special Requirements:
- Onsite position at a doctors office.
- Part-time 20 hours a week
- Contract
- Hourly Compensation
$40 - $50 an hourNOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.Apply for this job
